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Medical advancements and improvements in how doctors treat disease are made possible by what we learn through clinical trials. Commonly done in a medical setting such as a hospital, clinical trials are research studies that evaluate the safety and effectiveness of new treatments, whether they are drugs, devices, or preventative and other therapeutic measures that can influence health. Patients who participate in clinical trials have the opportunity to access treatments before they are publically available and also help others by contributing to medical research.  

Atlantic Health System hospitals participate in numerous clinical trials in partnership with other research organizations and pharmaceutical or biotech sponsors. Please browse the listing of clinical trials below to learn more about our open and active studies. Our physicians are committed to finding the latest treatments within a variety of medical areas, with a particular focus on cancer, genetics and congenital disease, movement disorders such as Parkinson’s disease, pediatrics, valve disease, and women’s health. 

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Acne
Open to Enrollment

A Randomized, Double-blind, Vehicle Controlled, Efficacy and Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil Gel compared to vehicle in patients with acne vulgaris.

Investigator:
Hilary Baldwin, MD
DRM01B-ACN03 | PHASE III

Sponsor:
Dermira, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 9 Years and older (Child, Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Signed informed consent and, for subjects under legal adult age, signed assent
• Age ≥ 9 years
• Clinical diagnosis of facial acne vulgaris defined as:
◦At least 20 inflammatory lesions, and
◦At least 20 non-inflammatory lesions, and
◦Investigator Global Assessment of 3 or greater

Exclusion Criteria:
• Active cystic acne or acne conglobata, acne fulminans, and secondary acne
• Two or more active nodulocystic lesions on the face
• Clinically significant abnormal laboratory or ECG result
• Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days or 5 half-lives (whichever is longer) of the Baseline visit
• Treatment with over-the-counter topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid on the face within 2 weeks prior to Baseline
• Treatment with systemic antibiotics or systemic anti-acne drugs or topical retinoid within 4 weeks prior to Baseline
• Treatment with a new hormonal therapy or dose change to existing hormonal therapy within 12 weeks prior to Baseline (hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills).
• Use of androgen receptor blockers (such as spironolactone or flutamide) within 2 weeks prior to Baseline.
• Oral retinoid use (e.g., isotretinoin) within 12 months prior to Baseline or vitamin A supplements greater than 10,000 units/day within 6 months prior to Baseline
• Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks

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973-630-2200
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Acne
Open to Enrollment

An Open-Label Study Assessing Long-Term Safety of Olumacostat Glasaretil Gel in Subjects with Acne Vulgaris

The objectives of this study are to assess the long-term safety of Olumacostat Glasaretil gel, 5.0% in patients with acne vulgaris.

Investigator:
Hilary Baldwin, MD
DRM01B-ACN05 | PHASE III

Sponsor:
Dermira, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 9 Years and older (Child, Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Signed informed consent or assent (for subjects under legal adult age)
• Completed Week 12 visit of either DRM01B-ACN03 or DRM01B-ACN04 studies.
• Willing to comply with the protocol. Subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol
• Willing to refrain from using any treatments on the face for acne vulgaris, other than the investigational product, including topical or systemic antibiotics.

Exclusion Criteria:
• Abnormal clinically significant findings on physical exam, vital signs or ECG at Week 12 visit of either the DRM01-ACN03 or DMR01-ACN04 studies that would make further treatment with Olumacostat Glasaretil Gel contraindicated, as determined by the Investigator
• Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study

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973-630-2200
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Aortic Stenosis
Open to Enrollment

A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Requiring Aortic Valve Replacement Who Have Severe, Calcific, Symptomatic Aortic Stenosis

To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients with severe, symptomatic aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR).

Investigator:
John Brown, MD
Partner 3 | PHASE III

Sponsor:
Edwards Lifesciences LLC

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 65 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. 65 years of age or older at time of consent.
2. Symptomatic, severe, calcific aortic stenosis with the following TTE criteria:
◦Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg AND
◦AVA ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2/m2
3. Aortic valve annulus 273 mm2 - 683 mm2 measured by 3D imaging (CT, TEE or MRI)
4. Adequate iliofemoral access with minimum average vessel diameter of 5.5mm (20, 23, 26mm) and 6.0mm (29mm) and acceptable level of vessel calcification and tortuosity for safe device implant
5. NYHA Functional Class ≥ II
6. Heart team agrees the patient has a risk of operative mortality < 2% (e.g., STS <4).
7. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.

Exclusion Criteria:
1. ≥ 1/4 frailty. (Only 0/4 frail patients may be enrolled in the trial).
2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization with evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. Any one of the following criteria meets the diagnosis for MI:
◦Detection of a rise and/or fall of cardiac biomarker values (preferably cardiac troponin (cTn)) with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following:
◦Symptoms of ischemia
◦New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB)
◦Development of pathological Q waves in the ECG
◦Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
◦Identification of an intracoronary thrombus by angiography
3. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified
4. Severe aortic regurgitation (>3+)
5. Severe mitral regurgitation (>3+)
6. Pre-existing mechanical or bioprosthetic valve in any position. (Of note, mitral ring is not an exclusion).
7. Any patient with a balloon valvuloplasty (BAV) within 30 days of the valve implant procedure (unless BAV is a bridge to procedure after a qualifying ECHO).
8. Any therapeutic invasive cardiac procedure performed within 30 days of the valve implant procedure. Pre-planned PCI performed within 2 weeks prior to valve procedure or implantation of a permanent pacemaker or Implantable Cardioverter Defibrillator (ICD) is not considered exclusionary criteria.
9. Complex coronary artery disease:
◦Unprotected left main coronary artery
◦Syntax score > 32 (in the absence of prior revascularization)
10. Non-complex, flow limiting coronary artery disease requiring revascularization that cannot be treated at the time of or within 2 weeks prior to the valve procedure.
11. Patients with a planned concomitant surgical or transcatheter ablation for atrial fibrillation.
12. Leukopenia (WBC < 3000 cell/mL), anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt < 50,000 cell/mL)
13. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit.
14. Emergency interventional/surgical procedures within 30 days of the valve implant procedure
15. Any planned surgical or peripheral procedure to be performed within the 30 day follow-up from the valve implant procedure
16. Hypertrophic cardiomyopathy with or without obstruction (HOCM)
17. Ventricular dysfunction with LVEF < 45%
18. Cardiac imaging (echo, CT, and/or MRI) evidence of intracardiac mass, thrombus or vegetation
19. History of upper GI bleeding within 90 days of the valve implant procedure
20. Inability to tolerate anti-thrombotic/anticoagulation therapy during or after the valve implant procedure
21. Stroke or transient ischemic attack (TIA) within 180 days of the valve implant procedure
22. Renal insufficiency (eGFR < 40 ml/min per the Cock-croft-Gault formula) and/or renal replacement therapy at the time of screening
23. Active bacterial endocarditis within 180 days of the valve implant procedure
24. Severe lung disease (FEV1 < 50% predicted) or currently on home oxygen
25. Chronic liver disease (MELD Score ≥ 10 or Child-Pugh Class B or C)
26. Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (>5mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta.
27. Porcelain aorta
28. Complications with prior cardiac surgery (i.e., mediastinitis, prolonged intubation)
29. Patient refuses blood products
30. Severe chest deformity (i.e., pectus excavatum, mastectomy, iatrogenic radiation exposure)
31. BMI > 50 kg/m2
32. Estimated life expectancy < 24 months
33. Known blood dyscrasia
34. Aortic coarctation
35. Absolute contraindications or allergy to iodinated contrast that cannot be pre-medicated
36. Immobility that would prevent completion of study procedures
37. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. Observational studies are not considered exclusionary.
38. Patient refuses SAVR

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Aortic Stenosis
Open to Enrollment

A Randomized Evaluation of the TriGuard Embolic Deflection Device to Reduce the Impact of Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation

The Keystone Heart TriGuard™ device is an aortic embolism deflection device intended to reduce the amount of embolic material that may enter the carotid, subclavian, and vertebral arteries during transcatheter heart valve implantation. The objective of the...

Investigator:
Robert Kipperman, MD

study is to assess the safety and efficacy of the TriGuard™ embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with an active control group of patients undergoing unprotected transcatheter aortic valve implantation (TAVI).

REFLECT | PHASE II/III

Sponsor:
Keystone Heart Ltd.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. The patient is a male or non-pregnant female ≥18 years of age
2. The patient meets indications for transcatheter aortic valve implantation (TAVI)
3. The patient is willing to comply with protocol-specified follow-up evaluations
4. The patient, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).

Exclusion Criteria:
1. Patients undergoing transcatheter aortic valve implantation (TAVI) via the trans-axillary, trans-subclavian, or trans-aortic route
2. Patients undergoing transcatheter aortic valve implantation (TAVI) via the transapical approach due to friable or mobile atherosclerotic plaque in the aortic arch
3. Patients with a previously implanted prosthetic aortic valve (i.e., planned valve-in-valve transcatheter aortic valve implantation (TAVI))
4. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 14 days prior to index procedure per site standard test.
5. Patients with known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (according to definition) or AMI >72 hours preceding the index procedure, in whom Creatine Kinase (CK) and CK-MB have not returned to within normal limits at the time of procedure, or patients who are currently experiencing clinical symptoms consistent with new-onset AMI, such as nitrate-unresponsive prolonged chest pain.
6. Patients with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, patients who will refuse transfusion, or patients with an active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 6 months
7. Patients with known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year.
8. Patients with severe allergy or known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel, nitinol, stainless steel alloy, and/or contrast sensitivity that cannot be adequately pre-medicated.
9. Patients with a history of a stroke or transient ischemic attack (TIA) within the prior 12 months.
10. Patients with renal failure (estimated Glomerular Filtration Rate [eGFR] <30 mL/min, calculated from serum creatinine by the Cockcroft-Gault formula)
11. Patients with hepatic failure (Child-Pugh class C)
12. Patients with hypercoagulable states that cannot be corrected by additional periprocedural heparin
13. Patients presenting with cardiogenic shock at the time of the index procedure.
14. Patients with severe peripheral arterial disease that precludes delivery sheath vascular access
15. Patients in whom the aortic arch, innominate artery ostium, or proximal innominate artery is heavily calcified, severely atheromatous, or severely tortuous.
16. Patients with any other condition that would prevent adherence to the TriGuard HDH Instructions for Use.
17. Patients with contraindication to cerebral magnetic resonance imaging (MRI).
18. Patients who have a planned treatment with any other investigational device or procedure during the study period.
19. Patients planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the transcatheter aortic valve implantation (TAVI) procedure or within 10 days prior to the transcatheter aortic valve implantation (TAVI) procedure. NOTE: Diagnostic cardiac catheterization is permitted within 10 days prior to the transcatheter aortic valve implantation (TAVI) procedure.

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973-971-7541
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Aortic Stenosis
Open to Enrollment

Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis

This clinical trial is a prospective, randomized, controlled, multi-center study. Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 THV or clinical surveillance. Patients will be stratified...

Investigator:
Philippe Genereux, MD

by whether or not they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.

EARLY-TAVR | PHASE III

Sponsor:
Edwards Lifesciences LLC

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 65 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Severe aortic stenosis
2. Patient is asymptomatic
3. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site.

Exclusion Criteria:
1. Patient is symptomatic.
2. Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
3. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
4. Aortic valve is a unicuspid, bicuspid, or is non-calcified.
5. Severe aortic regurgitation (>3+).
6. Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.

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973-971-4205
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Aortic Stenosis
Open to Enrollment

Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)

The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve...

Investigator:
John Brown, MD

Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.

SURTAVI

Sponsor:
Medtronic, Inc.

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
•Subject must have STS mortality risk score ≥4% and ≤10%;
•Heart Team (consisting of at least one interventional cardiologist and one cardiac surgeon) unanimously agree on indication, treatment proposal, and eligibility for randomization based on their clinical judgment (including anatomy assessment, risk factors, etc.);
•Subject has severe aortic valve stenosis presenting with
a. Critical aortic valve area defined as an initial aortic valve area of ≤1.0 cm2 or aortic valve area index < 0.6 cm2/m2 AND
b. Mean gradient > 40 mmHG or Vmax > 4m/sec by resting echocardiogram [or dobutamine stress echocardiogram if subject has a left ventricular ejection fraction (LEVF) < 55%] or velocity ratio < 0.25;

•Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;
•Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits;
•Subject meets the legal minimum age to provide informed consent based on local regulatory requirements;

Exclusion Criteria:
•Subject has refused surgical aortic valve replacement (SAVR) as a treatment option;
•Any condition considered a contraindication for placement of a bioprosthetic valve (i.e. subject requires a mechanical valve);
•A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (including inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated;
•Blood dyscrasias as defined: leukopenia (WBC <1000mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy;
•Ongoing sepsis, including active endocarditis;
•Any condition considered a contraindication to extracorporeal assistance;
•Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to randomization;
•Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization;
•Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support;
•Recent (within 6 months of randomization)cerebrovascular accident (CVA) or transient ischemic attack (TIA);
•Active gastrointestinal (GI) bleeding that would preclude anticoagulation;
•Subject refuses a blood transfusion;
•Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);
•Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery;
•Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid conditions;
•Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-ups exams;
•Currently participating in an investigational drug or another device trial (excluding registries);
•Evidence of an acute myocardial infarction ≤30 days before the index procedure;
•Need for emergency surgery for any reason;
•True porcelain aorta (i.e. Heart Team agrees the aorta is not clampable for SAVR);
•Extensive mediastinal radiation;
•Liver failure (Child-C);
•Reduced ventricular function with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram;
•Uncontrolled atrial fibrillation (e.g. resting heart rate > 120 bpm);
•Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements;
•End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min;
•Pulmonary Hypertension (systolic pressure> 80mmHg);
•Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) < 750cc;
•Frailty assessments identify:
a. Subject is < 80 years of age and three or more of the following apply
b. Subject is ≥ 80 years of age and two or more of the following apply
◾Wheelchair bound
◾Resides in an institutional care facility (e.g. nursing home, skilled care center)
◾Body Mass Index < 20 kg/m2
◾Grip Strength < 16 kg
◾Katz Index Score ≤ 4
◾Albumin < 3.5 g/dL
•Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention;

Note: Additional anatomical and vascular exclusion criteria may apply.

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Aortic Stenosis
Open to Enrollment

The Medtronic TAVR 2.0 US Clinical Study

The study objective is to evaluate safety and efficacy of the Medtronic TAVR 2.0 system in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement.

Investigator:
Robert Kipperman, MD
TAVR 2.0

Sponsor:
Medtronic, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: Child, Adult, Senior
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Severe aortic stenosis, defined as aortic valve area of <1.0 cm2 (or aortic valve area index of <0.6 cm2/m2) by the continuity equation, AND mean gradient >40 mmHg OR maximal aortic valve velocity >4.0 m/sec by resting echocardiogram
2. STS score of ≥8 OR documented heart team agreement of ≥ high risk for AVR due to frailty or co-morbidities
3. Symptoms of aortic stenosis AND NYHA Functional Class II or greater
4. The subject and the treating physician agree that the subject will return for all required post procedure follow-up visits.

Exclusion Criteria:
1. Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve)
2. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre medicated:
◦aspirin or heparin (HIT/HITTS) and bivalirudin
◦ticlopidine and clopidogrel
◦nitinol (titanium or nickel)
◦contrast media
3. Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
4. Untreated clinically significant coronary artery disease requiring revascularization
5. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% by echocardiography, contrast ventriculography, or radionuclide ventriculography
6. End stage renal disease requiring chronic dialysis or creatinine clearance <20 cc/min.
7. Ongoing sepsis, including active endocarditis
8. Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to study procedure
9. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment
10. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
11. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
12. Gastrointestinal (GI) bleeding that would preclude anticoagulation
13. Subject refuses a blood transfusion
14. Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
15. Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions
16. Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams
17. Currently participating in an investigational drug or another device study (excluding registries)
18. Evidence of an acute myocardial infarction ≤30 days before the study procedure
19. Need for emergency surgery for any reason
20. Liver failure (Child-Pugh class C)
21. Subject is pregnant or breast feeding
22. Pre existing prosthetic heart valve in any position
23. Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation)
24. Severe mitral regurgitation
25. Severe tricuspid regurgitation
26. Moderate or severe mitral stenosis
27. Hypertrophic obstructive cardiomyopathy
28. Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation
29. Congenital bicuspid or unicuspid valve verified by echocardiography
30. Access vessel diameter <5.5 mm or <6.0 mm for patent LIMA

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Arrhythmia
Completed

Micra™ Transcatheter Pacing Study

The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing System and to assess long term performance.

Investigator:
Robert Coyne, MD
Micra | PHASE III

Sponsor:
Medtronic, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
•Subjects who have a Class I or II indication for implantation of a single chamber ventricular pacemaker according to ACC/AHA/HRS 2008 guidelines and any national guidelines
•Subjects who are able and willing to undergo the study requirements and are expected to be geographically stable for the duration of the follow-up.
•Subjects who are at least 18 years of age (or older, if required by local law).

Exclusion Criteria:
•Subjects who are entirely pacemaker dependent (escape rhythm <30 bpm).
•Subject has an existing or prior pacemaker, ICD or CRT device implant.
•Subject has unstable angina pectoris or has had an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment.
•Subjects with current implantation of neurostimulator or any other chronically implanted device which uses current in the body. Note that a temporary pacing wire is allowed.
•Subjects with a mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD).
•Subjects who are morbidly obese and physician believes telemetry communication of ≤5 inches (12.7 cm) could not be obtained with programmer head.
•Subjects whose femoral venous anatomy is unable to accommodate a 23 French introducer sheath or implant on the right side of the heart (for example, due to obstructions or severe tortuosity) in the opinion of the implanter.
•Subjects who are considered as unable to tolerate an urgent sternotomy
•Subjects with a known intolerance to Nickel-Titanium (Nitinol) Alloy.
•Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated.
•Subjects with a life expectancy of less than 12- months.
•Subjects who are currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Coenrollment in concurrent trials is only allowed when document pre-approval is obtained from the Medtronic study manager.
•Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control.
•Subjects with exclusion criteria required by local law (e.g. age, breast feeding, etc.).

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Arrhythmia
Open to Enrollment

Tachy Prediction Download (TPD) Study

The purpose of the Medtronic Tachy Prediction Download (TPD) study is to collect data from an implantable cardiac defibrillator (ICD) device that will be used to identify markers for imminent onset of ventricular arrhythmias.

Investigator:
Jonathan Sussman, MD
TACHY

Sponsor:
Medtronic Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population:
The study subjects will include patients currently implanted, or who will be implanted with a market-approved Medtronic Evera MRI® ICD.

Inclusion Criteria:
• Subject is implanted or will be implanted, with an Evera MRI device with properly functioning Medtronic tachycardia lead placed in the right ventricle (with or without atrial lead) with remaining device longevity of 4 years or more for:
◦ Secondary Prevention or,
◦ Primary Prevention and has had a device treated VT/VF or a device recorded episode of sustained VT/VF
• Subject is ≥ 18 years old
• Subject has previously documented history of VT/VF
• Subject must be willing and able to use Medtronic CareLink network monitoring system
• Subject provides signed and dated authorization and/or consent per institution and local requirements
• Subject is willing and able to comply with the protocol

Exclusion Criteria:
• Subject who received device for Primary Prevention indication and who has not had either a device treated VT/VF episode or a device recorded episode of sustained VT/VF
• Subject is enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
• Subject has chronic AF
• Subject has inherited disorders of ion transport mechanisms that predispose the subject to sudden death ("Channelopathies"): Long QT and Brugada Syndromes
• Subject with multiple implanted active devices that may cause an interruption of a transmission of device data to CareLink
• Subject has active electronic medical device other than an ICD
• Subject requires more than 25% atrial or ventricular pacing
• Subject has medical conditions that would limit study participation (per investigator judgment)
• Subject has projected life expectancy of less than 1 year
• Subject is pregnant or plans to be pregnant over the next year (females of child-bearing potential must have a negative pregnancy test within one week of enrollment and must practice a reliable form of birth control while enrolled in the study)
• Subject meets exclusion criteria required by local law (e.g. age, breastfeeding, etc.)

Contact:
973-971-4205
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Arthritis
Open to Enrollment

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Secukinumab 300 mg and 150 mg in Adult Patients With Active Psoriatic Arthritis After 16 Weeks of Treatment Compared to Placebo and to Assess the Safety, Tolerability and Efficacy up to 52 Weeks

To demonstrate that the efficacy of secukinumab 300 mg at Week 16 is superior to placebo in adult patients with active PsA based on the proportion of patients achieving an American College of Rheumatology 20 (ACR20) response.

Investigator:
Elliot Rosenstein, MD
CAIN457FUS01 | PHASE IV

Sponsor:
Novartis Pharmaceuticals Corporation - NJ

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Male or non-pregnant, non-lactating female patients at least 18 years of age
• Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
• Rheumatoid factor and anti-CCP antibodies negative
• Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis

Exclusion Criteria:
• Chest X-ray with evidence of ongoing infectious or malignant process
• Patients who ever received biologic immunomodulating agents including those targeting TNFα, IL-6 and IL-12/23 investigational or approved

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Arthritis
Open to Enrollment

Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry

Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will...

Investigator:
Sivia Lapidus, MD

be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including safety questions.

CARRA

Sponsor:
Duke Clinical Research Institute

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 2 Years to 21 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Sampling Method: Non-Probability Sample

Study Population
Children with pediatric rheumatic diseases enrolled from participating CARRA sites.

Inclusion Criteria:
1. Onset of rheumatic disease prior to age 16 years for JIA and onset prior to age 19 years for all other rheumatic diseases (see appendix A).
2. Subject (and/or parent/legal guardian when required) is able to provide written informed consent and willing to comply with study procedures.
3. Subject and/or parent/legal guardian can read either English or Spanish.
4. Subject and/or parent/legal guardian is willing to be contacted in the future by study staff.

Exclusion Criteria:
1. Greater than 21 years of age at the time of enrollment.

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Arthritis
Open to Enrollment

Prospective Outcomes Study: Vectra® DA Guided Care Compared to Usual Care

In this 12-month multi-center prospective, site-randomized, two-arm trial, approximately 265 biologic-naïve subjects with RA who are candidates for treatment intensification due to inadequate response to MTX monotherapy will be enrolled at up to 60 study sites.

Investigator:
Elliot Rosenstein, MD

In this 12-month multi-center prospective, site-randomized, two-arm trial, approximately 265 biologic-naïve subjects with RA who are candidates for treatment intensification due to inadequate response to MTX monotherapy will be enrolled at up to 60 study sites.

088-CL-01

Sponsor:
Crescendo Bioscience, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
Subjects will be eligible to participate in the study if they meet all the following criteria:
1. Willing and able to sign an ICF
2. Age 18 to 80 years at enrollment
3. Meets the 2010 ACR/EULAR criteria and/or 1987 criteria for RA, as determined by a board-certified rheumatologist ≥3 months prior to enrollment
4. Received uninterrupted treatment with weekly MTX begun ≥3 months prior to enrollment, at a stable dose of ≥15 mg per week for at least 4 weeks prior to enrollment. A history of therapy with split dose oral MTX or parenteral MTX is acceptable only if the weekly MTX dose was always ≤20 mg/week during the 3 months prior to enrollment.
5. CDAI >10 as assessed by the Investigator at screening
6. At least 3 swollen joints (SJC ≥3) and 3 tender joints (TJC ≥3) out of 28 joints as assessed by the Investigator at screening
7. Must be eligible for treatment intensification with non-biologic and biologic DMARDs
8. Documented evidence of seropositivity (RF and/or anti-CCP antibodies). Seronegative subjects are allowed if erosive disease attributable to RA is documented on X-rays.

Exclusion Criteria:
Subjects will be ineligible to participate in the study if they meet any of the following criteria:
1. Use of a non-biologic DMARD other than MTX within 3 months prior to enrollment
2. MTX administered SQ or as an oral split dose at >20 mg/week any time during the 3 months prior to enrollment
3.Two or more DMARDs used in combination (i.e., concomitantly), including but not limited to: MTX, HCQ, SSZ, LEF, cyclosporine, azathioprine, gold or penicillamine any time prior to enrollment
4. Biologic DMARD or JAKi use any time prior to enrollment
5. Any contraindication to use of MTX, HCQ, LEF or biologic DMARDs
6. Opiate use during the 2 weeks prior to enrollment
7. Oral corticosteroids during the month prior to enrollment at a dosage >10 mg/day prednisone (or equivalent) or at a non-stable dose ≤10 mg/day prednisone (or equivalent)
8. MTX intolerance prior to enrollment that limits its use
9. Inflammatory joint disease (other than RA) or any other systemic autoimmune disorder. (Osteoarthritis is not a basis for exclusion.)
10. Primary or secondary immunodeficiency
11. Active infection (excluding fungal infection of nail beds); or acute or chronic infection requiring hospitalization or treatment with parenteral systemic antibiotics within one month of enrollment or treatment with oral antibiotics within 2 weeks of enrollment
12. IA, intravenous or IM corticosteroids during the month prior to enrollment
13. Initiation or non-stable dosing of NSAIDs within 2 weeks prior to enrollment
14. Vectra DA testing within 6 months prior to enrollment
15. Live vaccine within 90 days of enrollment
16. Active substance abuse or psychiatric illness likely to interfere with protocol conduct
17. History of severe allergic or anaphylactic reaction to any monoclonal antibody therapy
18. Known infection with HIV (HIV testing will not be a requirement for trial entry); a past or current history of hepatitis B virus or hepatitis C virus infection
19. History of malignancy within the past five years or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ that has been treated or excised in a curative procedure
20. Pregnancy or inadequate contraception in women of childbearing potential
21. Breast feeding or lactating
22. Medical, psychiatric, cognitive or other conditions that, in the opinion of the Investigator, may compromise the ability of the subject to understand the study information, to give informed consent, to comply with the trial protocol, or to complete the study
23. Presently enrolled in another clinical trial Note: Screening for TB is not required for subjects participating in the study. If an Investigator is considering a subject for treatment with a biologic DMARD in the study, guidelines for TB screening need to be followed.

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Asthma
Open to Enrollment

A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Existing Asthma Therapy in Patients With Uncontrolled Severe Asthma.

This study aims to determine the efficacy and safety of QAW039 (Dose 1 and Dose 2), compared with placebo, when added to GINA steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2015) in each of the groups (patients with severe asthma and high eosinophil...

Investigator:
Robert Sussman, MD

counts and all patients with severe asthma)

QAW039A2314 | PHASE III

Sponsor:
Novartis Pharmaceuticals Corporation - NJ

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 12 Years and older (Child, Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Written informed consent.
• Male and female patients aged ≥12 years.
• A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.
• Evidence of airway reversibility or airway hyper- reactivity.
• FEV1 ≤80% of the predicted normal value for patients aged ≥18 years; FEV1 of ≤90% for patients aged 12 to <18 years
• An ACQ score ≥1.5
• A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.

Exclusion Criteria:
• Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.
• Subjects who have participated in another trial of QAW039.
• A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).
• History of malignancy with the exception of local basal cell carcinoma of the skin.
• Pregnant or nursing (lactating) women.
• Serious co-morbidities.
• Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin.

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908-934-0440
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Atrial Fibrillation
Open to Enrollment

LEFT ATRIAL APPENDAGE LIGATION WITH THE LARIAT+® SUTURE DELIVERY SYSTEM AS ADJUNCTIVE THERAPY TO PULMONARY VEIN ISOLATION FOR PERSISTENT OR LONGSTANDING PERSISTENT ATRIAL FIBRILLATION

This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary...

Investigator:
Timothy Mahoney, MD

vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation.

aMAZE

Sponsor:
SentreHEART, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Documented diagnosis of symptomatic persistent or longstanding persistent non-valvular atrial fibrillation
• Failed at least one Class I or III Antiarrythmic drug (AAD)
• Life expectancy ≥ 1 year;
• Willing and able to return to and comply with scheduled follow-up visits and tests; and
• Willing and able to provide written informed consent

Exclusion Criteria:
• Prior procedure involving opening of the pericardium or entering the pericardial space (e.g., coronary artery bypass graft, heart transplantation, valve surgery) where adhesions are suspected;
• Prior epicardial or endocardial atrial fibrillation ablation procedure;
• LA diameter > 6 cm as measured by computerized tomography;
• Documented embolic stroke, transient ischemic attach or suspected neurologic event within 3 months prior to the planned intervention;
• Currently exhibits New York Heart Association Class IV heart failure symptoms;
• Documented history of right heart failure specifically when right ventricle exceeds the left ventricular size;
• Documented history of myocardial infarction (MI) within 3 months prior to the planned study intervention;
• Documented history of unstable angina within 3 months prior to the planned study intervention;
• Documented symptomatic carotid disease, defined as > 70% stenosis or > 50% stenosis with symptoms;
• End Stage Renal Disease (ESRD) or documented history of renal replacement / dialysis;
• Current documented history of clinically significant liver disease which predisposes the subject to significant bleeding risk (clinically defined by the treating physician);
• Any history of thoracic radiation with the exception of localized radiation treatment for breast cancer;
• Current documented use of long-term treatment with corticoid steroids, not including use of inhaled steroids for respiratory diseases;
• Active pericarditis;
• Active endocarditis;
• Any documented history or autoimmune disease associated with pericarditis;
• Evidence of Pectus Excavatum (documented and clinically defined by the treating physician);
• Untreated severe scoliosis (documented and clinically defined by treating physician);
• Documented Left Ventricular Ejection Fraction (LVEF) < 30% within 30 days prior to planned intervention;
• Documented presence of implanted congenital defect closure devices, (e.g., atrial septal defect, patent foramen ovale or ventricular septal defect device);
• Previously attempted occlusion of the left atrial appendage (by any surgical or percutaneous method);
• Body Mass Index (BMI) > 40;
• Evidence of active Graves disease;

Additional Exclusion Criteria: Based on Screening / Pre-procedure Imaging
Subjects will also be excluded if they meet any of the following:
• Based on screening computed tomography angiography performed within 90 days prior to study intervention as confirmed by the core lab:
◦Left atrial appendage morphology: Superior-posterior oriented left atrial appendage (i.e. superior C shape), that has:
a.Left atrial appendage LARIAT-approach width ≥ 40 mm; or
b.Left atrial appendage distal apex extending posterior to the ostium of the appendage.
◦Left atrial appendage positioned behind the pulmonary artery; or
◦All other left atrial morphology: Left atrial appendage LARIAT approach width > 45 mm.
• Based on a peri-procedural imaging (transesophageal echocardiography) at time of LARIAT or catheter ablation) and confirmed by institution's designated LARIAT echocardiographer:
◦Intracardiac thrombus; or
◦Significant mitral valve stenosis (i.e., mitral valve stenosis < 1.5cm2)

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Atrial Fibrillation
Completed

reMARQable: nMARQ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation

To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).

Investigator:
Jonathan Sussman, MD
nMARQ

Sponsor:
Biosense Webster, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Patients with symptomatic paroxysmal AF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.
2. Patients who have failed at least one antiarrhythmic drug (AAD; class I or III, or atrioventricular (AV) nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic AF, or intolerance to the AAD.
3. Age 18 years or older.
4. Signed Patient Informed Consent Form (ICF).
5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Exclusion Criteria:
1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
2. Previous ablation for atrial fibrillation.
3. Patients on amiodarone at any time during the past 3 months prior to enrollment.
4. AF episodes lasting > 7 days.
5. Any cardiac surgery within the past 60 days (2 months) or valvular cardiac surgical procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
6. Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months).
7. Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months).
8. Documented left atrial thrombus on imaging.
9. History of a documented thromboembolic event within the past one (1) year.
10. Diagnosed atrial myxoma.
11. Presence of implanted cardioverter defibrillator (ICD).
12. Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
13. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
14. Women who are pregnant (as evidenced by pregnancy test if subject is of child-bearing age and potential) or breast feeding.
15. Acute illness or active systemic infection or sepsis.
16. Unstable angina.
17. Myocardial infarction within the previous 60 days (2 months).
18. Left ventricular ejection fraction <40%.
19. History of blood clotting or bleeding abnormalities.
20. Contraindication to anticoagulation (i.e., heparin, dabigatran, Vitamin K Antagonists such as warfarin).
21. Life expectancy less than 365 days (12 months).
22. Enrollment in an investigational study evaluating another device or drug.
23. Uncontrolled heart failure or NYHA Class III or IV heart failure.
24. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
25. Presence of a condition that precludes vascular access.
26. Left atrial size >50 mm.

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Bariatrics
Open to Enrollment

Bariatric Surgery for Adolescents with Associated Comorbidities and Body Mass Index (BMI) 35-39.9 kg/m2, or BMI ≥ 40 kg/m2

The principal goal of this prospective study is to establish the efficacy  of bariatric surgery to adolescent patients between the ages of 15-18 years old.  The study will evaluate improvement in comorbid conditions, quality of life, and lower BMI over a 2...

year time span.  The surgeries offered will be laparoscopic sleeve gastrectomy and laparoscopic gastric bypass. Improvement in weight and obesity-associated comorbidities will be measured at specific time intervals after surgery.

Adolescent Bariatric Registry

Sponsor:

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 15-18 Years Old
Genders Eligible for Study: Both

Inclusion Criteria:
Patient is an adolescent between the ages of 15-18 years old, has met the requirements for surgery and has been evaluated by one of the participating surgeons and is planned to undergo either sleeve gastrectomy or gastric bypass. The patient should have a body mass index (BMI) ≥ 35 kg/m2 and severe obesity-associated comorbidities (i.e. diabetes mellitus, hypertension, sleep apnea, coronary artery disease, fatty liver disease, polycystic ovarian syndrome, gastroesophageal reflux disease, dyslipidemia), or a BMI ≥ 40 kg/m2

Exclusion Criteria:
1. No exclusion criteria other than not meeting the inclusion criteria.
2. There are no exclusions based on gender, race or ethnic background

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Bariatrics
Open to Enrollment

Bariatric Surgery for Low BMI Patients, a Registry Study

The principal goal of this prospective study is to establish the efficacy of bariatric surgery in patients with body mass index (BMI) between 30.0-34.9 kg/m2 with obesity-related comorbidities or BMI 35 - 40 kg/m2 without comorbidities. In addition, this study...

will evaluate any changes in the patients’ comorbidities. The surgeries offered will be laparoscopic sleeve gastrectomy and laparoscopic gastric bypass. Improvement in weight and obesity-associated comorbidities will be measured at specific time intervals after surgery.

Bariatric Registry

Sponsor:

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and Older
Genders Eligible for Study: Both

Inclusion Criteria:
1.Patient has been evaluated by one of the participating surgeons and is planned to undergo either sleeve gastrectomy or gastric bypass. The patient should have a body mass index (BMI) 30-34.9 kg/m2 and obesity-associated comorbidities (i.e. diabetes mellitus, hypertension, sleep apnea, coronary artery disease, depression, polycystic ovarian syndrome, gastroesophageal reflux disease, dyslipidemia), or a BMI ≥ 35 kg/m2

Exclusion Criteria:
1. No exclusion criteria other than not meeting the inclusion criteria.
2. There are no exclusions based on gender, race or ethnic background.

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Bladder Cancer
Open to Enrollment

An Open-Label, Multi-Centre, Safety Study of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies.

To evaluate the safety, tolerability, and anti-tumor activity of the combination of durvalumab + tremelimumab or durvalumab alone in different solid tumors.

Investigator:
Dennis Lowenthal, MD
D4191C00068 | PHASE III

Sponsor:
AstraZeneca

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Age ≥ 18 years at the time of screening. For patients aged <20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative
2. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
3. Disease not amendable to curative surgery
4. Eastern Cooperative Oncology Group (ECOG) performance status as defined in the specific module.
5. Body weight >30 kg.
6. No prior exposure to anti-programmed death (PD) 1 or anti-PD-ligand (L) 1.
7. Adequate organ and marrow function.
8. Female patients of childbearing potential (i.e., not surgically sterile or post-menopausal) who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions for 180 days after the last dose of investigational product (IP).
9 .Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
◦ Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
◦ Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
10. Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from screening through 180 days after the last dose of IP.

For inclusion in the Module A of the study patients should fulfill the following criteria:
1. Histologically or cytologicaly confirmed locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract (including the urinary bladder, ureter, urethra and renal pelvis)
2. Disease that has progressed during or after at least one previous platinum or nonplatinum based chemotherapy, either for metastatic disease or progressive disease less than 12 months after adjuvant or neo-adjuvant chemotherapy
3. ECOG performance status 0-2

Exclusion Criteria:
1. Involvement in the planning and/or conduct of the study.
2. Previous IP assignment in the present study.
3. Concurrent enrollment in another clinical study or another sub-study of this protocol, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
4. Participation in another clinical study with an IP and receipt of any investigational anticancer therapy during the last / within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment.
5. Any concurrent chemotherapy, investigational agent, biologic, or hormonal therapy for cancer treatment.
6. Local treatment of isolated lesions for palliative intent is acceptable (e.g., local surgery or radiotherapy).
7. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
8. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
9. History of allogenic organ transplantation.
10. Uncontrolled intercurrent illness (ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
11. History of another primary malignancy, leptomeningeal carcinomatosis and active primary immunodeficiency.
12. Has untreated central nervous system (CNS) metastases and/or carcinomatous meningitis identified either on baseline brain imaging (please refer to RECIST for details on the imaging modality) obtained during the screening period or identified prior to signing the ICF
13. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (positive HIV ½ antibodies).
14. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab.
15. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]).
16. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
17. Known allergy or hypersensitivity to study drug(s) or compounds of similar biologic composition to the study drug(s), or any of the study drug excipients.
18. Any unresolved NCI CTCAE Grade ≥2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia, and the laboratory values defined in the inclusion criteria.
19. Pregnant or breastfeeding women or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab + tremelimumab combination therapy.
20. Prior randomization or treatment in a previous durvalumab and/or tremelimumab clinical study regardless of treatment arm assignment.

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Bladder Cancer
Open to Enrollment

Open-Label, Multicenter, Ph 3 Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium™ in Subjects With Non Muscle-Invasive Carcinoma in Situ and/or High-Grade Papillary Disease of the Bladder Treated With BCG

Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. Vicinium is an experimental agent that may provide an alternative...

Investigator:
Ayal Kaynan, MD

to cystectomy

VB4-845-02-IIIA | PHASE III

Sponsor:
Viventia Bio Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Histologically-confirmed non muscle-invasive bladder cancer - CIS, high grade Ta or any grade T1 papillary disease or CIS plus papillary disease following adequate BCG treatment.
2. The CIS, Ta or T1 disease is documented as unresponsive to (i.e., not intolerant) adequate BCG therapy. Adequate BCG therapy is defined as at least 7 instillations of BCG over 2 cycles. (1 induction course of at least 5 doses over 6 weeks + 1 maintenance cycle of at least 2 doses over 6 weeks, or up to 2 induction courses) of BCG (with or without interferon).
3. Male or non-pregnant, non-lactating female.
4. Females of childbearing potential and all males with partners of childbearing age are eligible only if they agree to use highly effective contraceptive techniques or abstinence during the 24-month study period.
5. Bladder biopsy mapping the location of the tumors and quantifying the affected area of bladder within 8 weeks before study drug administration.
6. Life expectancy of at least 4 years.
7. Adequate organ function, as defined by the following criteria:
a. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x upper limit of normal (ULN);
b. Total serum bilirubin ≤1.5 x ULN (CTCAE Grade ≤1);
c. Serum creatinine ≤2.0 x ULN; subjects with serum creatinine >1 x ULN must also have creatinine clearance ≥50 mL/min;
d. Hemoglobin ≥8.0 g/dL; subjects receiving therapeutic erythropoietin preparations (i.e., epoetin alfa, darbepoetin alfa) are eligible to enroll;
e. Absolute neutrophil count ≥1500 x 109/L;
f. Platelets ≥75,000 x 109/L.
8. Ability to understand and sign an Independent Ethics Committee- or Institutional Review Board-approved informed consent document.

Exclusion Criteria:
1. The subject is pregnant or breastfeeding.
2. Evidence of urethral or upper tract transitional cell carcinoma (TCC) by biopsy or upper tract radiological imaging or evidence of higher stage disease by pelvic imaging within the past 2 years .
3. Subjects with hydronephrosis, except for those subjects where hydronephrosis has been longstanding (i.e., predates the diagnosis of the CIS, Ta or T1 by more than 2 years) and diagnostic evaluation at screening shows no evidence of tumor.
4. Any intravesicular or other chemotherapy treatment within 2 weeks or any investigational agent within 4 weeks prior to the initial dose of study drug.
5. Current severe urinary tract infection or history of recurrent severe bacterial cystitis.
6. Active, uncontrolled impairment of the urogenital, renal, hepatobiliary, cardiovascular, gastrointestinal, neurologic or hematopoietic systems which, in the opinion of the Investigator, would predispose the subject to the development of complications from the administration of intravesical therapy and/or general anesthesia.
7. History of other primary malignancy (other than squamous or basal cell skin cancers) that will require concomitant cancer therapy during the 24 months of the study.
8. A QTc interval of >450 msec for males or > 470 msec for females at the Screening ECG.
9. Subjects who, in the opinion of the Investigator, cannot tolerate intravesical administration or intravesical surgical manipulation.

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Bowel Disease
Open to Enrollment

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children, Ages 6 to 17 Years, A Multicenter, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation (IBS-C) (ie, Fulfill Rome III Criteria for Child/Adolescent IBS and Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation

The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years. This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment...

Investigator:
Alycia Leiby, MD

Period. Patients age 7-11 will receive oral liquid or oral solid capsule and patients 12-17 will receive solid oral capsule formulation. Children ages 7-11 years meeting the entry criteria will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks. This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of IBS-C.

LIN-MD-63 | PHASE II

Sponsor:
Forest Research Institute, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 7 Years to 17 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Patient weighs at least 18 kg (39.7 lbs)
• Patient meets Rome III criteria for child/adolescent IBS: at least once per week for at least 2 months before Screening Visit, the patient experienced abdominal discomfort (an uncomfortable sensation not described as pain) or pain associated with 2 or more of the following at least 25% of the time:
a. Improvement with defecation
b. Onset associated with a change in frequency of stool
c. Onset associated with a change in form (appearance) of stool
• Patient meets modified Rome III criteria for child/adolescent Functional Constipation (FC): For at least 2 months before the Screening Visit, the patient has had 2 or fewer defecations (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) in the toilet per week. In addition, at least once per week, patient meets 1 or more of the following:
a. History of retentive posturing or excessive volitional stool retention
b. History of painful or hard bowel movements (BMs)
c. Presence of a large fecal mass in the rectum
d. History of large diameter stools that may obstruct the toilet
• Patient is willing to discontinue any laxatives used before the Pretreatment Visit in favor of the protocol-permitted rescue medicine
• Patient has an average of fewer than 3 spontaneous BMs (SBMs) per week during the 14 days before the randomization day and up to the randomization. An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM
• Patient or parent/guardian/LAR or caregiver is compliant with eDiary by completing both the morning and evening assessments for 10 out of the 14 days immediately preceding the Randomization Visit

Exclusion Criteria:
• Patient reports having more than 1 loose, mushy stool (eDiary-recorded stool consistency of 6 on the Pediatric Bristol Stool Form Scale [p-BSFS]) or any watery stool (eDiary-recorded stool consistency of 7 on the p-BSFS) with any SBM that occurred in the absence of laxative use on the calendar day of the BM or the calendar day before the BM during the 14 days before the randomization day and up to the randomization
• Select medical history or conditions that may be related to other causes of constipation or may interfere with safety and efficacy analyses
• Patient has required manual or hospital-based disimpaction any time prior to randomization
• Patient is unable to tolerate the placebo during the Screening Period

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Bowel Disease
Open to Enrollment

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children, Ages 6 to 17 Years, Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)

The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of functional constipation (FC), in children age 6-17 years This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients...

Investigator:
Alycia Leiby, MD

age 6-11 will receive oral liquid formulation and patients 12-17 will receive solid oral capsule or liquid oral solution. Children ages 6-11 years meeting the entry criteria will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks. This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of FC.

LIN-MD-62 | PHASE II

Sponsor:
Forest Research Institute, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 6 Years to 17 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Patient weighs at least 18 kg (39.7 lbs)
• Patient meets modified Rome III criteria for child/adolescent FC: For at least 2 months before the Screening Visit, the patient has had 2 or fewer defecations (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) in the toilet per week
• In addition, at least once per week, patient meets 1 or more of the following:
a. History of retentive posturing or excessive volitional stool retention
b. History of painful or hard bowel movements (BMs)
c. Presence of a large fecal mass in the rectum
d. History of large diameter stools that may obstruct the toilet
• Patient is willing to discontinue any laxatives used before the Pretreatment Visit in favor of the protocol-permitted rescue medicine
• Patient has an average of fewer than 3 spontaneous BMs (SBMs) per week during the 14 days before the randomization day and up to the randomization. An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM
• Patient or parent/guardian/LAR or caregiver is compliant with eDiary by completing both the morning and evening assessments for 10 out of the 14 days immediately preceding the Randomization Visit

Exclusion Criteria:
• Patient meets Rome III criteria for Child/Adolescent irritable bowel syndrome (IBS): At least once per week for at least 2 months before the Screening Visit, the patient has experienced abdominal discomfort (an uncomfortable sensation not described as pain) or pain associated with 2 or more of the following at least 25% of the time:
a. Improvement with defecation
b. Onset associated with a change in frequency of stool
c. Onset associated with a change in form (appearance) of stool
• Patient reports having more than 1 loose, mushy stool (eDiary-recorded stool consistency of 6 on the Pediatric Bristol Stool Form Scale [p-BSFS]) or any watery stool (eDiary-recorded stool consistency of 7 on the p-BSFS) with any SBM that occurred in the absence of laxative use on the calendar day of the BM or the calendar day before the BM during the 14 days before the randomization day and up to the randomization
• Select medical history or conditions that may be related to other causes of constipation or may interfere with safety and efficacy analyses
• Patient has required manual or hospital-based disimpaction any time prior to randomization
• Patient is unable to tolerate the placebo during the Screening Period

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Bowel Disease
Open to Enrollment

A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease

The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.

Investigator:
Razvan Arsenescu, MD
64304500CRD2001 | PHASE II

Sponsor:
Janssen R & D

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Have Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
• A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [b-hCG]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0
• Adhere to the following requirements for concomitant medication for the treatment of Crohn's disease, which are permitted provided that doses meeting these requirements are stable, or have been discontinued, for at least 3 weeks before baseline (Week 0), unless otherwise specified: a) Oral 5-aminosalicylic acid (5-ASA) compounds, b) Oral corticosteroids at a prednisone-equivalent dose at or below 40 milligram per day (mg/day), or 9 mg/day of budesonide, or 5 mg/day beclomethasone dipropionate, c) Antibiotics being used as a primary treatment of Crohn's disease, d) Conventional immunomodulators (that is, azathioprine (AZA), 6-mercaptopurine (6-MP), or Methotrexate (MTX)): participants must have been taking them for at least 12 weeks and at a stable dose for at least 4 weeks before baseline
• A participant who has had extensive colitis for greater than or equal to (>=) 8 years, or disease limited to the left side of the colon for >= 12 years, must either have had a colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study agent or a colonoscopy to assess for the presence of malignancy at the screening visit, with no evidence of malignancy
• Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of >= 220 but <= 450

Exclusion Criteria:
• Participants who have received intravenous (IV) corticosteroids less then (<)3 weeks or have received tumor necrosis factor-alpha (TNF-alpha) antagonist biologic agents (example, monoclonal antibody [mAb] therapies) or other agents intended to suppress or eliminate tumor necrosis factor-alpha (TNF-alpha) <8 weeks or have received Vedolizumab <16 weeks before the first administration of study drug
• Woman who is pregnant or planning pregnancy or is a man who plans to father while enrolled in the study or within 16 weeks after the last administration of study agent
• Participants with certain complications of Crohn's disease that would make it hard to assess response to study drug
• Participants with a history of or ongoing chronic or recurrent infectious disease
• Has previously received a biologic agent targeting interleukin (IL)-12 or IL-23, including but not limited to ustekinumab or briakinumab (ABT-874)

Contact:
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Bowel Disease
Open to Enrollment

A Phase 3 Multicenter, RandomizeEd, Double Blind, Placebo COntrolled, Parallel Group Study to Evaluate the Safety, Tolerability, & Efficacy of SER-109 vs. Placebo to Reduce Recurrence of ClOstRidium Difficile Infection (CDI) in Adults

Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group II. The purpose of this study is to demonstrate the superiority of SER-109...

Investigator:
Razvan Arsenescu, MD

vs placebo to reduce recurrence of CDI in adults up to 8 weeks after initiation of treatment.

SERES-012 | PHASE III

Sponsor:
Seres Therapeutics, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject must be able to provide written informed consent and understand the potential risks and benefits from study enrollment and treatment.
2. Male or female subject ≥ 18 years of age.
3. A qualifying episode of CDI as defined by:
1. ≥ 3 unformed stools per day for 2 consecutive days
2. A positive C. difficile stool toxin assay.
3. The requirement of CDI SOC antibiotic therapy (defined as 10 to 21 days of treatment with vancomycin [125 mg QID] and/or fidaxomicin [200 mg BID]).
4. An adequate clinical response following SOC antibiotic therapy, defined as (<3 unformed stools in 24 hours) for 2 or more consecutive days before randomization.

Exclusion Criteria:
1. Female subjects who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
2. Known or suspected toxic megacolon and/or known small bowel ileus.
3. Admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding). Note: nursing homes, rehabilitation, assisted living centers and acute care hospitals are acceptable.
4. Absolute neutrophil count of <500 cells/ml3
5. Major gastrointestinal surgery (e.g. significant bowel resection or diversion) within 3 months before enrollment (this does not include appendectomy or cholecystectomy), or any history of total colectomy or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e., restrictive procedures such as banding, are permitted).
6. History of active inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 3 months.
7. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (subjects on maintenance chemotherapy may only be enrolled after consultation with the study medical monitor).
8. Any history of fecal microbiota transplantation (FMT).

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Bowel Disease
Open to Enrollment

A Prospective, Multi-center Registry for Patients With Short Bowel Syndrome

This is a global prospective, observational, multi-center registry to evaluate the long-term safety profile for patients with short bowel syndrome (SBS) who are treated with teduglutide in a routine clinical setting. The registry will also evaluate the long-term...

Investigator:
Michael Rothkopf, MD

clinical outcomes in patients with SBS. SBS patients treated and not treated with teduglutide will be enrolled.

TED-R13-002

Sponsor:
NPS Pharmaceuticals, Inc.

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population

This registry is to enroll both male and female patients, of any age, with a diagnosis of SBS.
Criteria

Inclusion Criteria:
- Male and female patients, of any age, with a diagnosis of SBS
- Signed informed consent and medical records release by the patient or a legally acceptable representative

Exclusion Criteria:
- None

Contact:
973-971-7101
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Bowel Disease
Open to Enrollment

An Open-Label, Multicenter, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab Therapeutically

The purpose of this study is to assess the concentration of vedolizumab in breast milk of lactating women with active ulcerative colitis (UC) or Crohn's disease (CD) who are receiving vedolizumab therapeutically.

Investigator:
Razvan Arsenescu, MD
Vedolizumab-4001 | PHASE IV

Sponsor:
Takeda Development Center Americas, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Is capable of understanding and complying with protocol requirements.
2. Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
3. Is female and at least 18 years of age at the time of informed consent.
4. Weighs at least 50 kilogram at Screening and Day 1.
5. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent and throughout the duration of the study.
6. Is on established vedolizumab maintenance therapy of (received at least two 300 mg once every 8 weeks doses prior to the delivery of infant and one 300 mg once every 8 weeks dose of vedolizumab postpartum), which has been commenced by the participant's treating physician for the treatment of active UC or CD prior to enrolling in this study.
7. Has delivered a single, normal term infant (at least 37 weeks' gestation) that is, a mother-infant pair is required.
8. Is at least 6 weeks postpartum by Day 1.
9. Lactation is well established and the mother is exclusively breast feeding their infant (or not providing more than 1 supplemental bottle of formula/day) when enrolled in the study.
10. Participant has independently decided to be treated with vedolizumab or to breastfeed prior to providing consent to participate in this study.
11. Plans to continue breastfeeding at least throughout the duration of this study.
12. Agrees to use only the emollient or nipple cream recommended by the investigator for use during the sampling period as described per protocol.

Exclusion Criteria:
1. Has received any investigational compound or approved biologic or biosimilar agent, except for vedolizumab within 60 days prior to enrollment in the study.
2. Within 30 days prior to enrollment, the participant has received any of the following for the treatment of underlying disease:
a. Nonbiologic therapies [example (eg), cyclosporine], other than those listed in the protocol.
b. An approved nonbiologic therapy in an investigational protocol.
3. Is expected to receive additional vedolizumab treatment between Day 2 and Study Exit/Follow-up (Day 57).
4. Has received natalizumab treatment.
5. Has received any live vaccinations within 30 days prior to study drug administration.
6. Has a positive test result for hepatitis B surface antigen, antibody to hepatitis C virus, at Screening or a known history of human immunodeficiency virus infection (eg, common variable immunodeficiency, human immunodeficiency virus infection, organ transplantation).
7. Has clinically significant infection (eg, pneumonia, pyelonephritis) or chronic infection within 30 days prior to enrollment.
8. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
9. Has evidence of unstable or uncontrolled, clinically significant cardiovascular, central nervous system, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic or other medical disorder, including serious allergy, asthma, hypoxemia, hypertension, seizures or allergic skin rash that, in the opinion of the investigator, would confound the study results or compromise participant safety. Additionally, if there is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking vedolizumab, or a similar drug that might interfere with the conduct of the study.
10. Had any surgical procedure requiring general anesthesia within 30 days prior to enrollment or is planning to undergo major surgery during the study period.
11. Has any history of malignancy, except for the following: (a) adequately treated nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to enrollment; and (c) history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to enrollment. Participants with remote history of malignancy (eg, greater than (>) 10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received and must be discussed with the sponsor on a case-by-case basis prior to enrollment.
12. Has a positive progressive multifocal leukoencephalopathy subjective symptom checklist at screening.
13. Has a current or recent history (within 1 year prior to enrollment) of alcohol dependence or illicit drug use.
14. Has active psychiatric problems that, in the investigator's opinion, may interfere with compliance with the study procedures.
15. Has history of breast implants, breast augmentation, or breast reduction surgery.
16. Has a prior history of difficulty establishing lactation.
17. Has a positive urine/blood drug result for drugs of abuse (defined as any illicit drug use) at Screening.
18. Has donated or lost 450 milliliter or more of her blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days prior to Day 1.
19. Has active or latent tuberculosis (TB)

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Bowel Disease
Open to Enrollment

ECOSPOR IV: An Open-Label Extension of Study SERES 0012 Evaluating SER-109 in Subjects With Recurrent Clostridium Difficile Infection

Subjects who had a CDI recurrence in Study SERES-012 within 8 weeks of receipt of study drug will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days. The purpose of this study is to assess safety and efficacy of SER-109 in reducing...

Investigator:
Razvan Arsenescu, MD

recurrence of Clostridium difficile infection (CDI) in adults who had a CDI recurrence within 8 weeks after receipt of SER-109 or Placebo in Study SERES-012.

SERES-013 | PHASE III

Sponsor:
Seres Therapeutics, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Previously enrolled in Study SERES-012, had CDI recurrence within 8 weeks after receipt of study drug, and have completed their SERES-012 Week 8 visit.
2. Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject must be able to provide written informed consent and understand the potential risks and benefits from study enrollment and treatment.
3. The CDI recurrence in Study SERES-012 must have met the protocol definition of ≥ 3 unformed stools per day over 2 consecutive days, a positive C. difficile stool test, and assessment by the investigator that the clinical condition of the subject warranted treatment.

Exclusion Criteria:
1. Female subjects who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
2. Known or suspected toxic megacolon and/or known small bowel ileus.
3. Admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding). Note: nursing homes, rehabilitation, assisted living centers and acute care hospitals are acceptable.
4. Absolute neutrophil count of <500 cells/ml3
5. Major gastrointestinal surgery (e.g. significant bowel resection or diversion) within 3 months before enrollment (this does not include appendectomy or cholecystectomy), or any history of total colectomy or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e., restrictive procedures such as banding, are permitted).
6. History of active inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 3 months.
7. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (subjects on maintenance chemotherapy may only be enrolled after consultation with the study medical monitor).
8. Any history of fecal microbiota transplantation (FMT)

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Bowel Disease
Open to Enrollment

Entyvio (Vedolizumab) Long-term Safety Study: An International Observational Prospective Cohort Study Comparing Vedolizumab to Other Biologic Agents in Patients With Ulcerative Colitis or Crohn's Disease

The purpose of this study is to assess the long-term safety of vedolizumab versus other biologic agents in participants with Ulcerative Colitis (UC) or Crohn's Disease (CD).

Investigator:
Razvan Arsenescu, MD
MLN-0002_401

Sponsor:
Takeda Development Center Americas, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample

Study Population

Participants with ulcerative colitis (UC) or Crohn's disease (CD) who are initiating Entyvio or another biologic agent. Participants may be biologic-naive or have prior use of a biologic agent

Inclusion Criteria:
1. Signed informed consent, by the participant or a legally acceptable representative.
2. Aged at least 18 years.
3. Initiating vedolizumab or another biologic agent for UC or CD.
4. Signed release form, by the participant or a legally acceptable representative, permitting abstraction of the participant's medical records at Baseline and during participation in the study.

Exclusion Criteria:
1. The participant is enrolled in a clinical trial in which treatment for CD or UC is managed through a protocol.
2. Prior treatment with vedolizumab.
3. Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.

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Bowel Disease
Open to Enrollment

This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC) plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with known CD and mucosal disease. The primary objective of the study is to assess...

Investigator:
Razvan Arsenescu, MD

the accuracy of CE versus IC plus MRE for detecting active CD, by visualizing the small bowel and colon in subjects with known CD and mucosal disease.

BLINK

Sponsor:
Medtronic, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Subject has provided informed consent.
• Subject is ≥ 18 years of age
• Subject is willing and able to comply with all aspects of treatment and evaluation schedule.
• Subject has known CD and a recent history (within last 2 years) of mucosal disease (diagnosis based on radiologic, endoscopic, or histological evidence).

Exclusion Criteria:
• Subject has indeterminate, ulcerative, antibiotic-associated colitis.
• Subject has stool positive for ova and parasite and for Clostridium difficule toxins within 3 months prior to enrollment.
• Subject with other known infectious cause of abdominal symptoms.
• Subject with clinical evidence of renal disease with the past 6 months, defined as estimated glomerular filtration rate (GFR) outside the normal reference range.
• Subject with known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment.
• Subject with a diagnosis of gastroparesis or small bowel or large bowel dysmotility.
• Subjects with a history of small bowel or colonic resection.
• Subject with any current condition believed to have an increased risk of capsule retention such as suspected or known bowel obstruction, stricture, or fistula.
• Subject has used non-steroidal anti-inflammatory drugs including aspirin, two times per week, during the 4 weeks preceding enrollment. Low dose aspirin regimens (< 100 mg daily) are acceptable and not exclusionary.
• Subject suffers from any condition, such as swallowing problems, that precludes compliance with study and/or device instructions.
• Subject with cardiac pacemaker or other implanted electromedical device.
• Subject has an allergy or other known contraindication to the medications used in the study.
• Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding.
• Subject is considered to be a part of a vulnerable population (eg. prisoners or those without sufficient mental capacity).
• Subject has a known contraindication to MRE or IC.
• Subject has participated in a drug or device research study within 30 days of enrollment that may interfere with the subject's safety or ability to participate in the study.
• Subject has any medical condition that would make it unsafe for them to participate, per Investigator's descretion

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Brain Cancer
Open to Enrollment

A Phase 2/3 Randomized, Open-Label Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC Versus Standard of Care in Subjects Undergoing Planned Resection for Recurrent Glioblastoma or Anaplastic Astrocytoma

This is a multicenter, randomized, open-label phase 2/3 study of Toca 511 and Toca FC versus standard of care that comprises Investigator's choice of single agent chemotherapy (lomustine or temozolomide) or bevacizumab administered to subjects undergoing resection...

Investigator:
Yaron Moshel, MD

for first or second recurrence (including this recurrence) of GBM or AA. Subjects meeting all of the inclusion and none of the exclusion criteria will be randomized prior to surgery in a 1:1 ratio to receive either Toca 511 and Toca FC (Experimental arm, Arm T) or control treatment with one option of standard of care (Arm SOC). Due to the prognostic influence of molecular subgroups such as isocitrate dehydrogenase mutation, the trial will be stratified based on this determination from the primary pathology or subsequent biopsy known locally or otherwise determined centrally.

Tg511-15-01 | PHASE II/III

Sponsor:
Tocagen Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Subject has given written informed consent
2. Subject is between 18 years old and 75 years old, inclusive
3. Subjects must have histologically proven GBM or AA in first or second recurrence (including this recurrence) or progression following initial definitive multimodal therapy with surgery, temozolomide (unless MGMT promoter unmethylated) and radiation (confirmed by diagnostic biopsy with local pathology review or contrast enhanced MRI). If first recurrence of GBM is documented by MRI, an interval of at least 12 weeks after the end of prior radiation therapy is required unless there is either: i) histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI outside of the radiotherapy treatment field
4. Subjects must have measurable disease preoperatively, defined as at least 1 contrast enhancing lesion, measuring at least 1 cm in 2 planes (axial, coronal, or sagittal)
5. Subjects must be at least 4 weeks post last dose of temozolomide
6. Prior gamma knife, stereotactic radiosurgery, or other focal high-dose radiotherapy is allowed but the subject must have either histopathologic confirmation of recurrent tumor, or new enhancement on MRI outside of the radiotherapy treatment field
7. Based on the pre operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region
8. IDH mutation status of the primary tumor must be available or tumor samples must be available for pre randomization testing
9. Laboratory values adequate for patient to undergo surgery, including:
◦ Platelet count ≥ 60,000/mm3
◦ Hgb ≥ 10 g/dL
◦ Absolute neutrophil count (ANC) ≥ 1,500/mm3
◦ Absolute lymphocyte count (ALC) ≥ 500/mm3
◦ Adequate liver function, including:
◾ Total bilirubin ≤ 1.5 x ULN (unless has Gilbert's syndrome)
◾ ALT ≤ 2.5 x ULN f. Estimated glomerular filtration rate of at least 50 mL/min by the Cockcroft Gault formula below:
10. Women of childbearing potential (≥12 months of non-therapy-induced amenorrhea or surgically sterile) must have had a negative serum pregnancy test within the past 21 days and must use a birth control method in addition to barrier methods (condoms).
11. Subject or subject's partner is willing to use condoms for 12 months after receiving Toca 511 or until there is no evidence of the virus in his/her blood, whichever is longer.
12. The subject has a KPS ≥ 70
13. The subject is willing and able to abide by the protocol

Exclusion Criteria:
1. History of more than 2 prior recurrences (including this recurrence) of GBM or AA
2. History of other malignancy, unless the patient has been disease free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment
3. Histological confirmed oligodendroglioma or mixed glioma
4. Known 1p/19q co deletion
5. A contrast enhancing brain tumor that is any of the following:
◦ Multi focal (defined as 2 separate areas of contrast enhancement measuring at least 1 cm in 2 planes that are not contiguous on either fluid attenuated inversion recovery (FLAIR) or T2 sequences);
◦ Associated with either diffuse subependymal or leptomeningeal dissemination; or > 5 cm in any dimension
6. The subject has or had any active infection requiring antibiotic, antifungal or antiviral therapy within the past 4 weeks
7. The subject has any bleeding diathesis, or must take anticoagulants, or antiplatelet agents, including nonsteroidal anti inflammatory drugs (NSAIDs), at the time of the scheduled resection that cannot be stopped for surgery
8. The subject is HIV positive
9. The subject has a history of allergy or intolerance to flucytosine
10. The subject has a gastrointestinal disease that would prevent him or her from being able to swallow or absorb flucytosine
11. The subject received cytotoxic chemotherapy within the past 4 weeks (6 weeks for nitrosoureas) of the planned surgery date
12. The subject received any investigational treatment within the past 30 days or prior immunotherapy or antibody therapy within the past 45 days.
13. The subject is breast feeding
14. The subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery or has received the Gliadel® wafer < 30 days from W1D1 (surgery)
15. The subject has received bevacizumab for their disease unless in the context of primary therapy for newly diagnosed glioma
16. For subjects planned to potentially receive bevacizumab, they have no evidence of uncontrolled hypertension (defined as a blood pressure of ≥ 150 mm Hg systolic and/or ≥ 100 mm Hg diastolic on medication) or active GI perforation
17. The subject has received systemic dexamethasone continuously at a dose > 8 mg/day for 8 weeks prior to the date of the screening assessment
18. Severe pulmonary, cardiac or other systemic disease, specifically:
◦ New York Heart Association > Grade 2 congestive heart failure within 6 months prior to study entry, unless asymptomatic and well controlled with medication
◦ Uncontrolled or significant cardiovascular disease, clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or Torsades des pointes), clinically significant pulmonary disease (such as ≥ Grade 2 dyspnea, according to CTCAE 4.03)
◦ Subjects who have any other disease, either metabolic or psychological, which as per Investigator assessment may affect the subject's compliance or place the subject at higher risk of potential treatment complications

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Brain Cancer
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A Phase II/III Randomized Trial of Veliparib or Placebo in Combination With Adjuvant Temozolomide in Newly Diagnosed Glioblastoma With MGMT Promoter Hypermethylation

This randomized phase II/III trial studies how well temozolomide and veliparib work compared to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme. Drugs used in chemotherapy, such as temozolomide, work in different ways to...

Investigator:
Kurt Jaeckle, MD

stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective with or without veliparib in treating glioblastoma multiforme.

A071102 | PHASE II/III

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Criteria


Inclusion Criteria:
•Histologic documentation: newly diagnosed World Health Organization (WHO) grade IV intracranial glioblastoma or gliosarcoma; GBM with oligodendroglial features are NOT PERMITTED in this study if they are 1p19q codeleted; sites submitting GBM with oligodendroglial features will be asked to provide results of 1p/19q codeletion status
•Sufficient tissue available for central pathology review and MGMT methylation status evaluation
•Patients who have had a local MGMT testing that is unmethylated are not allowed to participate
•Tumor MGMT promoter hypermethylation determined by central testing at MD Anderson
•Confirmation by central pathology review of WHO grade IV glioblastoma or gliosarcoma
• Absolute neutrophil count (ANC) >= 1500 cells/mm^3 within 14 days prior to study registration
• Platelets >= 100,000 cells/mm^3 within 14 days prior to study registration
• Creatinine =< 1.5 x upper limit of normal (ULN) within 14 days prior to study registration
• Bilirubin =< 1.5 x ULN within 14 days prior to study registration; unless patient has Gilbert's disease
• Alanine aminotransferase (ALT) =< 3 x ULN within 14 days prior to study registration
• Aspartate aminotransferase (AST) =< 3 x ULN within 14 days prior to study registration
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Measurable disease or non-measurable disease; extent of resection: patients with complete resection, partial resection, or biopsy are eligible
• Progression: patients deemed to have progressive disease based on clinical deterioration after chemoradiation or radiographic progression outside of the radiation field are not eligible; patients deemed to have pseudoprogression are eligible
• Prior treatment:
◦ Must have completed standard radiotherapy and concomitant TMZ therapy as defined and determined by the study oncologist
◦ Besides concomitant TMZ with radiation, no other therapy (neo-adjuvant or adjuvant) can be given prior to study registration, including chemotherapy (also including Gliadel/carmustine [BCNU] wafers), biologics, immunotherapy, radiation therapy; the only exception is the Optune device (NovoTTF-100A), which may be started any time after end of radiation therapy up through the initiation of Cycle 1; intent to use Optune must be declared at registration for stratification
• Not pregnant and not nursing; females of childbearing potential must have negative urine or serum pregnancy test within 7 days of registration but before start of treatment; a female of childbearing potential is a sexually mature female who:
◦ Has not undergone a hysterectomy or bilateral oophorectomy; or
◦ Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• Concomitant medications: patients receiving anticoagulation should be on stable dose 2 weeks prior to registration
• Comorbid conditions: patients are unable to participate due to the following:
◦ Generalized or partial seizure disorder that is uncontrolled at the time of registration; the definition of controlled generalized seizures is patients must be on a stable dose of anti-seizure medication and without generalized seizures for at least 10 days prior to registration; the definition of controlled partial seizures is patients must be on a stable dose of anti-seizure medication for at least 10 days prior to registration; patients with occasional breakthrough partial seizures are allowed at treating physician's discretion
◦ Grade 3 or 4 thromboembolic disease within 6 months (mo) of registration
◦ Known history of prolonged QT syndrome
• No history of major surgery =< 14 days prior to registration

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Brain Cancer
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A Pivotal Randomized, Controlled Trial of VAL-083 in Patients With Recurrent Glioblastoma Who Have Failed Standard Temozolomide/Radiation Therapy and Bevacizumab (STAR-3)

This is an adaptive design, randomized controlled, Phase 3 clinical trial in patients with glioblastoma multiforme (GBM) or gliosarcoma (GS), previously treated with surgery (if appropriate), standard of care chemo-radiation with temozolomide, +/- adjuvant...

Investigator:
Kurt Jaeckle, MD

temozolomide, and bevacizumab and now has progressive disease during or after bevacizumab.

DLM-16-002 | PHASE III

Sponsor:
DelMar Pharmaceuticals (BC) Ltd.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Patient must agree to testing of GBM tumor promoter methylation status of the MGMT gene and tumor (IDH1) gene mutation status. Tissue may be tested at study entry, if not done previously, or data may be obtained from last known test result for MGMT and IDH1. IDH1 status may be assessed at study entry, but MGMT status is required prior to randomization.
2. Agree to allow the sponsor to collect data on all GBM-related treatments received after the patient comes off the current study, and to collect survival data after the patient comes off the current study.
3. Patient must be ≥ 18 years old.
4. Histologically confirmed initial diagnosis of primary glioblastoma multiforme (GBM) or gliosarcoma (GS), now recurrent. Patients with recurrent/progressive disease whose initial diagnostic pathology confirmed GBM or GS will not need re-biopsy. Patients with prior low-grade glioma or anaplastic glioma are eligible, if histologic assessment demonstrates transformation to GBM or GS.
5. Patient has previously received standard of care chemo-radiation with temozolomide, ± adjuvant temozolomide and bevacizumab and now has radiographic evidence of recurrent/progressive GBM or GS during or after bevacizumab.
6. Patient must have bi dimensionally measurable disease, per the proposed Response Assessment in NeuroOncology (RANO; Appendix C) (Wen et al., 2010), with measurement of >1 cm in one diameter and ≤5 cm diameter in any plane on MRI performed within 2 weeks prior to randomization.
7. At least 4 weeks from last chemotherapy or bevacizumab (Avastin®) therapy (6 weeks for nitrosourea or mitomycin C), or for chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity, at least 2 weeks from last dose.
8. If the patient has been using the Optune™ device, it will be discontinued at least four days prior to commencing treatment with VAL-083, and the patient must have recovered from all treatment-related toxicities to Grade 1 or less.
9. Baseline MRI must be obtained ≥ 4 weeks after surgical resection but within 2 weeks prior to randomization.
10. Adequate recovery from all recent surgery is required; at least 1 week must have elapsed from the time of a minor surgery; at least 21 days must have elapsed from the time of a major surgery. Patients must have recovered from all surgery-related toxicities to Grade 1 or less.
11. Prior therapy with Laser-Induced Thermal Therapy (LITT) is allowed but at least 21 days must have elapsed from last LITT, with recovery from all LITT-related toxicities to Grade 1 or less and subsequent histologic documentation of recurrence.
12. Greater than 12 weeks from radiotherapy, to minimize the potential for MRI changes related to radiation necrosis that might be misdiagnosed as pseudoprogression of disease, unless the recurrence is a new lesion, outside the primary radiation field or the patient fulfills criteria for early progressive disease by RANO ((Wen et al., 2010); Appendix C).
13. Prior therapy with gamma knife or other focal high-dose radiation is allowed, but at least 2 weeks must have elapsed from the time of treatment, and the patient must have subsequent post-radiotherapy histologic documentation of recurrence in the irradiated field, unless the recurrence is a new lesion outside the irradiated field.
14. If receiving corticosteroids, patients must be on a stable or decreasing dose of corticosteroids for ≥ 5 days prior to baseline MRI.
15 .At least 28 days or 5 half-lives (whichever is shorter) since prior investigational anti-cancer drugs. A minimum of 21 days between termination of the investigational drug and administration of VAL-083 is required.
16. Must have recovered from all treatment-related toxicities to Grade 1 or less.
17. Patients must have a Karnofsky performance status (KPS; Appendix D) of ≥ 70%
18. KPS must have been stable during the period from wash-out of prior therapy to randomization. A declining KPS is defined by reduction of 10 points or more over at least a 28-day period.
19. Patient must have a predicted life expectancy of at least 12 weeks.
20. Laboratory values as follows at screening and within 7 days of planned first dose of therapy:
1. Absolute neutrophil count (ANC) ≥1500/μL.
2. Hemoglobin (HgB) ≥9 g/dL.
3 .Platelets ≥100,000/μL (≥150,000/μL, if within 12 weeks of prior nitrosourea treatment).
4. Serum creatinine ≤1.5 x upper limit of normal or creatinine clearance >60 mL/min (measured or calculated by the Cockcroft-Gault formula) (Cockcroft DW et al, 1976).
5. AST, ALT must be <2 x ULN.
6. Total bilirubin <1.5 x the institutional ULN, unless the subject has documented unconjugated bilirubin disorder such as Gilbert's syndrome.
7. Subjects with known Gilbert's syndrome who have serum bilirubin ≤ 3 x ULN (NCI CTCAE v4.03 Grade 2) may be enrolled.
8. International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.5 x the ULN.
9. QTc <450 msec on screening ECG.
21. No clinically significant cardiac conduction disorder on screening.
22. Female patients of child-bearing potential must have a negative serum or urine pregnancy test within 7 days prior to planned first dose of treatment, and agree to use dual method of contraception through 90 days after study drug treatment. Approved methods of contraception include an IUD with spermicide, a female condom with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, use of a condom with spermicide by sexual partner or a sterile sexual partner. Women of childbearing potential are defined to include any female who:
1. Has experienced menarche and has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy); and
2. Is not post-menopausal (defined as amenorrhea >12 consecutive months).
23. If male, patient must be sterile or willing to use an approved method of contraception from the time of Informed Consent to 90 days after study drug treatment. Males must be willing to refrain from sperm donation within 90 days after study treatment.

Exclusion Criteria:
1. Current history of neoplasm other than the entry diagnosis. Exceptions are:
1. Curatively treated basal cell/squamous cell skin cancer
2. Carcinoma in situ of the cervix
3. Patients with previous solid and hematologic tumors, that have been treated with no evidence of recurrence within the last 5 years, are permitted.
2. Evidence of diffuse subependymal disease or tumor in the brainstem, cerebellum, spinal cord, or CSF.
3. Radiological evidence of multifocal disease, tumors extending into or crossing the corpus callosum or leptomeningeal disease.
4. Need for urgent palliative intervention for primary disease (e.g., impending herniation).
5. Evidence of recent hemorrhage on baseline MRI of the brain with the following exceptions:
1. Presence of hemosiderin.
2. Resolving hemorrhagic changes related to surgery.
3. Presence of punctate hemorrhage in the tumor.
6. Concurrent severe, intercurrent illness including, but not limited to unstable systemic disease, including ongoing or active infection, uncontrolled hypertension, serious cardiac arrhythmia requiring medication, or psychiatric illness/social situations that would limit compliance with study requirements.
7. Any of the following cardiac conditions:
1. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, and/or stenting up to 12 weeks before Cycle 1, Day 1.
2. Class III or IV heart failure as defined by the New York Heart Association functional classification system up to 6 months before Cycle 1, Day 1.
8. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair, or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of treatment.
9. History of stroke or transient ischemic attack within 6 months prior to beginning treatment.
10. Patients receiving prohibited concomitant medications at the start of the study
11. Patients with steroid myopathy.
12. Patients who are HIV positive with an active AIDS-related illness are excluded; patients who are HIV positive but on stable therapy are not excluded.
13. Patients with a known sensitivity to any of the products to be administered during treatment and assessments.
14. Women who are pregnant or lactating.
15. Patients unable to undergo an MRI of the brain with contrast.

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Brain Cancer
Open to Enrollment

Phase II Trial of SMO/AKT/NF2 Inhibitors in Progressive Meningiomas With SMO/AKT/NF2 Mutations

This phase II trial studies how well vismodegib and focal adhesion kinase (FAK) inhibitor GSK2256098 work in treating patients with meningioma that is growing, spreading, or getting worse. Vismodegib and FAK inhibitor GSK2256098 may stop the growth of tumor...

Investigator:
Kurt Jaeckle, MD

cells by blocking some of the enzymes needed for cell growth.

A071401 | PHASE II

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Criteria

•Documentation of disease:
◦Histologic documentation: histologically proven intracranial meningioma as documented by central pathology review
◦Molecular documentation: presence of SMO, PTCH1 or NF2 mutation in tumor sample as documented by central laboratory
◦Progressive OR residual disease, as defined by the following:
◾Residual measurable disease: residual measurable disease immediately after surgery without requirement for progression; for grade I disease, progression pre-operatively needs to be documented, with an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area); the change must occur between scans separated by no more than 12 months; residual measurable disease will be defined by bidimensionally measurable lesions with clearly defined margins by MRI scans, with a minimum diameter of 10 mm in both dimensions
◾Progressive measurable disease: progression defined as an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area); the change must occur between scans separated by no more than 12 months
◾Post radiation patients: patients with measurable and progressive meningioma who have received radiation are potentially eligible, but need to show evidence of progressive disease after completion of radiation; at least 24 weeks must have elapsed from completion of radiation to registration


•Measurable disease: measurable disease is defined by a bidimensionally measurable main lesion on MRI or computed tomography (CT) images (MRI preferred) with clearly defined margins; multifocal disease is allowed
•Prior treatment
◦Prior medical therapy is allowed but not required
◦No limit on number of prior therapies
◦No chemotherapy, other investigational agents within 28 days of study treatment
◦No other concurrent investigational agents or other meningioma-directed therapy (chemotherapy, radiation) while on study
◦For patients treated with external beam radiation, interstitial brachytherapy or radiosurgery, an interval > 24 weeks must have elapsed from completion of radiation therapy to registration
◦Steroid dosing stable for at least 4 days
◦Recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or less toxicity from other agents with exception of alopecia and fatigue
◦No craniotomy within 28 days of registration

•Not pregnant and not nursing:
* A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

•Eastern Cooperative Oncology Group (ECOG) performance status =< 2
•Patient history:
◦Patients with history of neurofibromatosis (NF) may have other stable central nervous system (CNS) tumors (schwannoma, acoustic neuroma or ependymoma) if lesions have been stable for 6 months
◦No metastatic meningiomas (as defined by extracranial meningiomas) allowed
◦No history of allergic reactions attributed to compounds of similar or biologic composition to assigned study drug
◦No known active hepatitis B or C
◦No current Child Pugh class B or C liver disease
◦No uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease within 28 days of registration)
◦No uncontrolled diabetes defined as a known diabetic with hemoglobin A1C (HBA1C) > 7.5 OR fasting glucose > 140
◦No uncontrolled hypertension defined as blood pressure (BP) > 140/90
◦No abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 28 days prior to registration

•Concomitant medications:
◦Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors must discontinue the drug for 14 days prior to registration on the study for patients with NF2 mutation enrolled to GSK2256098
◦Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment for patients with NF2 mutation enrolled to GSK2256098

•Absolute neutrophil count (ANC) >= 1,500/mm^3
•Platelet count >= 100,000/mm^3
•Creatinine OR =< 1.5 mg/dl x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance > 45 mL/min
•Urine protein:creatinine ratio (UPC) =< 45 mg/mmol; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)
•Total bilirubin =< 1.5 x upper limit of normal (ULN); except in case of Gilbert's disease
•Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
•Fasting triglyceride =< 200 mg/dL; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)
•Fasting cholesterol =< 240 mg/dL; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)
•Corrected QC interval calculated using Fridericia's formula (QTcF) =< 500 msec; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)

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Brain Cancer
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Phase III Intergroup Study of Radiotherapy With Concomitant and Adjuvant Temozolomide Versus Radiotherapy With Adjuvant PCV Chemotherapy in Patients With 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether...

Investigator:
Kurt Jaeckle, MD

giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

N0577 | PHASE III

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Pre-Registration Inclusion Criteria:
Central Pathology Review Submission: This review is mandatory prior to registration to confirm eligibility. Patients must be willing to submit tissue samples for mandatory central pathology review submission and deletion status determination. It should be initiated as soon after surgery as possible.

Registration Inclusion Criteria:
1. Age ≥ 18 years
2. Newly diagnosed and ≤ 3 months from surgical diagnosis
3. Histological confirmation of anaplastic glioma (oligodendroglioma, mixed, or astrocytoma [WHO grade 2 or 3] or low grade glioma [WHO grade 2], as determined by pre-registration central pathology review. Note: Mixed gliomas are eligible, regardless of the degree of astrocytic or oligodendrocytic predominance, as long as the tumor is also co-deleted for 1p and 19q.
4. Patients with codeleted low grade gliomas must also be considered "high risk" by clinical criteria utilized in RTOG 9802 and must be either: age ≥ 40 and any surgical therapy or age < 40 and subtotal resection or biopsy.
5. Tumor tissue must show co-deletion for the relevant portions of chromosomes 1p and 19q by FISH analysis, as defined by the testing laboratory.
6. Surgery (partial or gross total resection or biopsy) must be performed ≥ 2 weeks prior to registration. Patient must have recovered from the effects of surgery.
7. The following laboratory values obtained ≤ 21 days prior to registration.
a. Absolute neutrophil count (ANC) ≥ 1500/mm^3
b. Platelet (PLTs) count ≥ 100,000/mm^3
c. Hemoglobin (Hgb) > 9.0g/dL
d. Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
e. Serum glutamic oxaloacetic transaminase (SGOT) aspartate transaminase (AST) ≤ 3 x ULN
f. Creatinine ≤ 1.5 x ULN
8. Negative serum or urine pregnancy test done ≤ 7 days prior to registration for women of childbearing potential only.
9. Willing and able to complete neurocognitive testing without assistance and the Quality of Life (QOL) questionnaires with or without assistance
10. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
11. Provide informed written consent.
12. Willing to return to enrolling institution for follow-up during the Active Monitoring Phase (ie, active treatment and observation portion) of the study
13. Mandatory Tissue Samples for Correlative Research -Patient willing to provide tissue samples for correlative research purposes

Registration Exclusion Criteria:
1. Fetal/Newborn Toxicity: Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects: Pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception during this study and for up to 6 months following the completion of temozolomide treatments.
2. Received any prior surgery, radiation therapy or chemotherapy for any central nervous system (CNS) neoplasm. Note: Patients who have had a prior low grade glioma with or without surgery and who now have anaplastic glioma with no prior radiation or chemotherapy are eligible for the study.
3. Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
4. Concomitant serious immunocompromised status (other than that related to concomitant steroids) that would compromise the safety of the patient on the study.
5. Patients known to be Human Immunodeficiency Virus (HIV) positive and currently receiving retroviral therapy. Note: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for the study.
6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
7. Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
8. Other active malignancy within 5 years of registration. Exceptions:
Non-melanotic skin cancer or carcinoma in situ of the cervix. Note: If there is a history of prior malignancy, the patient must not be receiving other specific treatment (other than hormonal therapy) for their cancer.
9. History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
10. Recent history of hepatitis infection or treating physician determined that the patient would be at significant risk of reactivation of hepatitis.

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Brain Cancer
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Randomized Phase II Study: Corticosteroids + Bevacizumab vs. Corticosteroids + Placebo (BEST) for Radionecrosis After Radiosurgery for Brain Metastases

This randomized phase II study aims to investigate whether the addition of bevacizumab to standard corticosteroid therapy results in greater improvement in symptoms and less treatment-induced symptoms compared with standard corticosteroid therapy for patients...

Investigator:
Kurt Jaeckle, MD

with symptomatic brain radionecrosis following radiosurgery. It is hypothesized that the addition of bevacizumab to standard care corticosteroids will reduce treatment-induced toxicities and improve neurologic impairments in patients with brain radionecrosis following radiosurgery for brain metastases.

A221208 | PHASE II

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Pre-Registration Eligibility Criteria:
1. Patients who present with symptomatic brain radionecrosis after they have received radiosurgery for brain metastases from primary solid tumor including but not limited to lung, breast, colorectal cancer but excluding melanoma, choriocarcinoma, renal cell carcinoma or gliomas
2. Patients at institutions that elect to utilize central imaging review to confirm eligibility must be pre-registered prior to submission of these images; images should be submitted as soon as possible after the pre-registration magnetic resonance imaging (MRI) is obtained; turnaround time for this review will be =< 72 business hours after receipt of images by the Imaging and Radiation Oncology Core (IROC)
3. Patients at institutions that elect to confirm eligibility locally may be pre-registered at the same time as they are randomized

Registration/Randomization Eligibility Criteria:

1. A diagnosis of radionecrosis will be based on a clinical onset of symptoms and radiological findings of radionecrosis at 3-24 months following radiosurgery, with or without pathological confirmation.
1.1 'Symptomatic' brain radionecrosis to at least one lesion following radiosurgery treatment for brain metastases where 'symptomatic' is defined as:
1.1.1 New or increasing headache associated with mass effect, sensory or motor abnormality, cognitive changes, speech difficulty, balance or coordination difficulty, cranial nerve deficits
1.1.2 Symptoms are persistent or worsening despite administration of at least dexamethasone 4 mg daily for 1 week
1.2 Clinical eligibility supported by central imaging real-time review. The presence of at least the following conventional MR image characteristic:
1.2.1 Conventional MR - Lesion quotient of < 0.3, where lesion quotient is defined as the proportional value of the maximum axial cross-sectional area of the T2-weighted defined lesion over the maximum axial cross-sectional area of the contrast-enhancing lesion on the T1-weighted post-gadolinium sequence on a comparable axial slice. If the conventional MR findings are not seen, the following dynamic susceptibility-contrast (DSC) MR characteristics may be used to meet eligibility for this study.
1.2.2 DSC MR - The cut-offs below will be based on GRE EPI DSC perfusion images, acquired without using a gadolinium pre-load:
1.2.2.1 Relative cerebral blood volume (rCBV) <1.5 in the enhancing- lesion relative to normal-appearing white matter (NAWM)
1.2.2.2. Percentage of signal recovery (PSR) > 76%, where PSR is determined by comparing the lower signal intensity during passage of the contrast bolus with the post-contrast signal intensity on the signal intensity-time curve
1.2.3 Centers that standardly use PET or MRS to determine a diagnosis of radionecrosis are permitted to use these modalities to assist in their patient selection; however the criteria described for conventional MR and/or DSC should also be met for study eligibility. Both PET and MRS are not mandatory for study eligibility.
2.Prior to start of treatment
2.1 Must have been taking a stable dose of corticosteroids for symptom management for at least 1 week before baseline MRI.
2.2 No systemic therapy within 2 weeks prior to registration or plan for systemic therapy within the first 8 weeks after study registration. The protocol provides a list of 'approved systemic' therapies that are allowed for concurrent use with bevacizumab.
2.3 No bevacizumab ≤ 3 months of study registration.
2.4 Central imaging real-time review (72 hour turn around) to confirm eligibility.
3. Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 14 days prior to registration and confirmation they are not nursing is required.
4. Age ≥ 18 years
5. Karnofsky Performance Status ≥ 60%
6. Required Initial Laboratory Values ≤14 days of registration:
6.1 Absolute Neutrophil Count (ANC) ≥ 1,500/mm^3
6.2 Platelet Count ≥ 100,000/mm3
6.3 Hemoglobin ≥ 10 g/dL*
6.3.1 allowing transfusion or other intervention to achieve this minimum hemoglobin
6.4 BUN < 30 mg/dL
6.5 Creatinine < 1.7 mg/dL
6.6 Bilirubin ≤ 2.0 mg/dL
6.7 ALT ≤ 3.0 x upper limits of normal (ULN)
6.8 AST ≤ 3.0 x ULN
6.9 INR <1.5 x ULN**
6.9.1 unless patients are receiving anti-coagulation therapy. Patients receiving anti-coagulation therapy with an agent such warfarin or heparin are allowed to participate if INR ≤ 3.0.**
6.10 UPC Ratio <0.5 or if ≥ 0.5
6.10.1 24-hour urine protein must be <1000 mg
7. Able to participate in patient-report outcomes (MDASI-BT, DSQ-C, LASA) questionnaires.
Assistance by research personnel is acceptable if participant has disabilities that make reading or writing difficult.
8. No evidence of recent hemorrhage at pre-registration MRI of the brain, however the following are permitted: presence of hemosiderin, resolving hemorrhagic changes related to surgery, and presence of punctate hemorrhage in the tumor.
9. No excess risk of bleeding (any of the following):
9.1 Bleeding diathesis or coagulopathy
9.2 Thrombocytopenia
9.3 Major surgical procedure, open biopsy, or significant traumatic injury within the past 28 days or anticipation of need for major surgical procedure during the course of the study.
9.4 Minor surgical procedures, stereotactic biopsy, fine need aspiration, or core biopsy within the past 7 days.
10. No clinically significant cardiovascular disease.
10.1 No uncontrolled hypertension (systolic blood pressure ≤ 160 mm Hg or diastolic ≤ 100 mm Hg). Patients with hypertension must be adequately controlled with appropriate anti-hypertensive therapy or diet.
10.2 No history of arterial thrombotic events within the past 6 months, including:
10.2.1 transient ischemic attack (TIA)
10.2.2 cerebrovascular accident (CVA)
10.2.3 peripheral arterial thrombus
10.2.4 unstable angina or angina requiring surgical or medial intervention
10.2.5 myocardial infarction (MI)
10.2.6 significant peripheral artery disease (i.e., claudication on less than one block)
10.2.7 significant vascular disease (i.e., aortic aneurysm, history of aortic dissection)
10.3 Patients who have had a deep vein thrombosis or pulmonary embolus within the past 6 months are eligible if they are on stable therapeutic anticoagulation.
10.4 No current New York Heart Association classification II, III, or IV congestive heart failure.
11. No history of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within past 12 months.
12. No central lung metastases with excessive active bleeding.
13. No uncontrolled intercurrent illness including, but not limited to any of the following:
ongoing or active infection requiring IV antibiotics, cardiac arrhythmia, or psychiatric illness and/or social situations that would limit compliance with study requirements.
14. No history of serious non-healing wound, ulcer, or bone fractures.

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Breast Cancer
Open to Enrollment

A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Negative Breast Cancer: The ABC Trial

This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin...

Investigator:
Michael Kane, MD

is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.

A011502 | PHASE III

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 69 Years (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Criteria

1.Documentation of Disease - Histologic Documentation: Histologic documentation of women or men with node positive, HER2 negative, anatomic stage II or III breast carcinoma within one year of diagnosis and free of recurrence. If neoadjuvant therapy was received, either initial clinical stage (determined by physical and or radiologic examination) or post-operative pathologic stage can be used for eligibility purposes, with the higher stage determining eligibility. Histologic documentation of node positivity is required.
2.Disease status - Any ER/PgR status allowed.
3.Prior Treatment - Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined the treating physician, is allowed. The last dose of chemotherapy or radiation therapy must be at least 60 days prior to study registration. Concurrent hormonal therapy will be allowed.
4.Regular NSAID/aspirin use (defined as ≥ 5 days per week) is allowed if aspirin and/or NSAIDs are stopped for one year prior to study entry and throughout the study period. Participants will be encouraged to use acetaminophen for minor pain and fever.
5.Patients must be enrolled within 1 year after diagnosis.
6.Age > 18 and < 70 years of age.
7.ECOG performance status 0-2.
8.Patients with a prior history of gastric/duodenal ulcers documented on endoscopy can be enrolled as long as the ulcers did not cause bleeding requiring a blood transfusion/major intervention.
9.For patients who are Helicobacter pylori positive, a course of Helicobacter pylori eradication treatment must have been completed.
10.No history of GI bleeding requiring a blood transfusion, endoscopic or operative intervention.
11.No history of any prior stroke (hemorrhagic or ischemic).
12.No concurrent anticoagulation with warfarin or heparin or clopidogrel or oral direct thrombin inhibitors.
13.No history of atrial fibrillation or myocardial infarction.
14.No history of grade 4 hypertension, defined as hypertension resulting in life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis).
15.No chronic (duration >30 days) daily use of oral steroids.
16.No known allergy to aspirin.
17.No prior malignancy of any type within the past 5 years other than breast cancer, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
18.Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use.
19.Required Initial Laboratory Values Platelet count ≥ 100,000/mm3

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Breast Cancer
Completed

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients With High-Risk, Hormone Receptor-Positive and HER2/Neu Negative Breast Cancer

Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus...

Investigator:
Steven Papish, MD

may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.

S1207 | PHASE III

Sponsor:
Southwest Oncology Group

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:
•Patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen (ER)- and/or progesterone-receptor (PR) status, and negative human epidermal growth factor receptor (HER)2, for whom standard adjuvant endocrine therapy is planned
◦ER and PR positivity must be assessed according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as either ER or PR ≥ 1% positive nuclear staining
◦HER2 will be determined by immunohistochemistry (IHC) or non-amplified fluorescent in situ hybridization (FISH) or chromogenic in situ hybridization (CISH)
◾If HER2 IHC is 2+, FISH/CISH must be performed and must not be positive (must be a ratio of ≤ 2), but otherwise FISH/CISH is not required if IHC is 0 or 1+ by institutional standards
•Patients must not have inflammatory breast cancer and must not have metastatic breast cancer (stage IV disease); patients with multifocal, multicentric, and synchronous bilateral breast cancers are allowed
◦Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant
◦Multicentric disease is defined as more than one invasive cancer ≥ 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants
◦Synchronous bilateral disease is defined as invasive breast cancer in both breasts, diagnosed within 30 days of each other
•Patients must be high risk by belonging to one of the following risk groups:
◦Completion of adjuvant chemotherapy and pathologically negative axillary nodes, and a tumor measuring ≥ 2 cm in greatest diameter, and an Oncotype DX® recurrence score (RS) > 25 (completed as standard of care)
◦Completion of adjuvant chemotherapy, and pathologically 1-3 positive axillary lymph nodes, and an Oncotype DX® RS > 25 (screened via S1007 or otherwise)
◦Completion of adjuvant chemotherapy and pathologically 4 or more positive axillary lymph nodes independent of the Oncotype DX® RS in the primary tumor
◦Completion of neoadjuvant chemotherapy and 4 or more positive nodes pathologically determined prior to or after chemotherapy
•Patients must have completed either breast-conserving surgery or total mastectomy, with negative margins and appropriate axillary staging; a negative margin is defined as no evidence of tumor or ductal carcinoma in situ (DCIS) at the line of resection; additional operative procedures may be performed to obtain clear margins
◦Patients who had breast-conserving surgery must have completed whole-breast radiation; use of regional nodal-basin radiation will be at the discretion of the investigator according to institutional guidelines
◦Patients with ≥ 4 positive lymph nodes must have completed breast/chest wall and nodal-basin radiation therapy according to standard-of-care guidelines before randomization; omission of radiation therapy is not allowed in this high-risk population of patients
◦Patients must be registered no sooner than 21 days after completion of radiation therapy and must have recovered (≤ grade 1) from any of the effects of radiation
•Patients must have undergone axillary staging by sentinel-node biopsy or axillary lymph node dissection (ALND)
◦For patients with 1-3 positive lymph nodes, sentinel-node biopsy alone is allowed provided that the patient completed either whole-breast or chest-wall radiation and the primary tumor is < 2 cm
◦All patients with ≥ 4 positive lymph nodes must have completed ALND (with or without prior sentinel-node biopsy)

PATIENT CHARACTERISTICS:
•Peripheral granulocyte count ≥ 1,500/mL
•Hemoglobin ≥ 9 g/dL
•Platelet count ≥ 100,000/mL
•Bilirubin ≤ 1.5 mg/dL (≤ 3.0 mg/dL if due to Gilbert syndrome)
•Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times institutional upper limit of normal (IULN)
•Alkaline phosphatase ≤ 1.5 times IULN
•Serum creatinine level ≤ IULN
•Fasting cholesterol ≤ 300 mg/dL and triglycerides ≤ 2.5 times IULN; patients may be on lipid-lowering agents to reach these values
•Patients must have a performance status of 0-2 by Zubrod criteria
•Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
•Patients must not have uncontrolled diabetes (defined as a hemoglobin [Hg] A1C > 7% within 28 days prior to registration)
•Patients known to be human immunodeficiency virus (HIV) positive may be enrolled if baseline CD4 count is > 500 cells/mm³ and they are not taking anti-retroviral therapy
•Patients with known hepatitis are not eligible
•Patients must not have any known uncontrolled, underlying pulmonary disease
•Patients must be able to take oral medications
•Patients may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of blinded drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
•Patients must not be pregnant or nursing
•Women/men of reproductive potential must have agreed to use an effective non-hormonal contraceptive method during and for 8 weeks after completion of study therapy
◦In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; corresponding procedures for men include castration, vasectomy, and barrier-contractive devices
◦If at any point a previously celibate patient chooses to become heterosexually active during the protocol therapy, he/she is responsible for beginning contraceptive measures
•No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:
•See Disease Characteristics
•Patients must have completed standard neoadjuvant or adjuvant chemotherapy prior to randomization; completion of chemotherapy will be determined by the treating oncologist, but should include a minimum of 4 courses (a course of weekly paclitaxel is considered 3 doses); patients must be registered within 21 weeks after completion of chemotherapy; patients may have started endocrine therapy at any time after the diagnosis of the current breast cancer
•Patients must not be receiving or planning to receive trastuzumab
•Concurrent bisphosphonate therapy is allowed
•Patients must not have prior exposure to mTOR inhibitors (rapamycin, everolimus, temsirolimus, deforolimus)
•Patients must not have prior treatment with any investigational drug within the preceding 28 days and must not be planning to receive any other investigational drug for the duration of the study
•Patients must not be planning to receive any other anticancer drug for the duration of the study
•Patients must not have an organ allograft or other history of immune compromise; patients must not be receiving chronic, systemic treatment with corticosteroids or other immunosuppressive agent; topical or inhaled corticosteroids are allowed
•Patients must not have received immunization with an attenuated live vaccine (e.g., intranasal influenza, measles, mumps, and rubella [MMR], oral polio, varicella, zoster, yellow fever, and Bacillus Calmette-Guérin [BCG] vaccines) within seven days prior to registration nor have plans to receive such vaccination while on protocol treatment
•Patients must not have taken within 14 days prior to registration, be taking, nor plan to take while on protocol treatment, strong cytochrome P450 3A4 (CYP3A4) inhibitors and/or CYP3A4 inducers

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Breast Cancer
Open to Enrollment

Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women With Early Breast Cancer

This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed)...

Investigator:
Michael Kane, MD

have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.

A011401 | PHASE III

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Criteria:
1.Documentation of Disease:
1.1 Subjects must have histologically confirmed invasive breast cancer and registration must occur within 12 months after the first histologic diagnosis of invasive breast cancer.
◦A core biopsy interpreted as invasive cancer meets this criterion; if no core biopsy is performed, the date of first histologic diagnosis will be the date of first surgical procedure that identifies invasive cancer (biopsy, lumpectomy or mastectomy).
◦Neoadjuvant subjects should have no evidence of clinical T4 disease prior to chemotherapy and surgery; eligibility for neoadjuvant patients can be defined by either clinical stage prior to therapy or pathologic stage at surgery; if patient is eligible based on either, they are eligible for the study.
◦Bilateral breast carcinoma is allowed provided diagnoses are synchronous - that is, within 3 months of one another - and at least one of the two breast carcinomas meet the eligibility criteria and neither Her-2 positive or inflammatory.
◦No evidence of metastatic disease
1.2 Her-2 negative, defined as:
◦In-situ hybridization (ISH) ratio of < 2.0 (if performed)
◦Immunohistochemistry (IHC) staining of 0-2+ (if performed)
◦Deemed to not be a candidate for Her-2 directed therapy.
1.3 Eligible tumor-node-metastasis (TNM) Stages include:
◦Estrogen receptor (ER) and Progesterone receptor (PR) negative (defined as <1% staining for ER and PR by IHC): T2 or T3 N0, T0-3N1-3. Note: Patients with T1, N1mi disease are NOT eligible.
◦ER and/or PR positive (defined as ≥ 1% staining for ER and/or PR on IHC): T0-3N1-3 or T3N0. Note: Patients with T1-2, N1mi disease are NOT eligible
◦The eligibility of neo-adjuvant subjects can be assessed on the basis of clinical (c)TNM or pathologic (yp)TNM. The same eligible TNM combinations apply; patients may be eligible if they meet eligibility requirements at either time point, as long as they do not have T4 disease prior to therapy.
1.4 No history of invasive breast cancer in 5 years prior to study registration other than the current diagnosis (prior ductal breast carcinoma in situ [DCIS] at any time is acceptable).
1.5 Patients must have had a bilateral mammogram within 12 months prior to registration, unless the initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required. (Subjects with bilateral total mastectomies do not require imaging).
1.6 Investigations, including chest X-ray or computed tomography (CT) chest, bone scan (with radiographs of suspicious areas) and abdominal ultrasound or liver scan or CT abdomen have been performed between the first histologic diagnosis and the time of registration as detailed below.
◦Chest X-Ray, 2 view (or Chest CT, or positron emission tomography [PET]/CT) is mandatory
◦Bone scans (with x-rays of abnormal areas) are required only if alanine aminotransferase (ALT), aspartate aminotransferase (AST) or Alkaline Phosphatase is elevated or if there are signs or symptoms of metastatic disease
◦Abdominal imaging is required only if ALT, AST or Alkaline Phosphatase is elevated or if there are signs or symptoms of metastatic disease
2.Prior Treatment
2.1 All adjuvant or neoadjuvant chemotherapy, radiation, and surgery completed at least 21 days prior to registration.
2.2 All triple negative patients must receive chemotherapy of the treating physician's choice.
2.3 ER/PR+ patients must receive chemotherapy (of the treating physician's choice) unless Oncotype Dx or another genomic predictor score indicates that they are at low or intermediate risk of disease recurrence with endocrine therapy alone.
2.4 Patients may have breast reconstruction during protocol participation, but definitive breast cancer surgery must be completed at least 21 days prior to registration.
Concomitant biologic therapy, hormonal therapy, and bisphosphonates are acceptable.
2.5 Surgical margins must be clear of invasive carcinoma. If there is microscopic residual ductal in situ disease present at lumpectomy or total mastectomy margins, further excision is highly recommended. If further excision is not undertaken, the subject may still be entered on study, provided that in addition to breast or chest wall irradiation, a boost to the tumor bed is delivered. In situ lobular disease at the margin is acceptable.
2.6 All subjects (both adjuvant and neoadjuvant) must have sentinel lymph node biopsy and/or axillary lymph node dissection. Sentinel lymph node biopsy alone is allowed in the following instances:
◦Sentinel lymph node biopsy is negative: pN0
◦Sentinel lymph node biopsy is positive for isolated tumor cells only:
pN0 (i+)
◦Clinically node negative, T1-2 tumors with sentinel lymph node biopsy positive in < 2 lymph nodes without matted nodes and undergoing breast conserving surgery and tangential whole breast irradiation, or undergoing mastectomy and chest wall irradiation.
◦For patients who had a positive node prior to neoadjuvant chemotherapy, sentinel node alone is allowed after neoadjuvant therapy if:
◾Sentinel node biopsy is negative after chemotherapy and either at least 2 sentinel nodes were removed or a clip was placed in the involved node prior to treatment.
◾=< 2 lymph nodes are positive for cancer and the patient is participating in A011202
◦All women who undergo breast conserving therapy must receive concomitant radiotherapy. Radiation after mastectomy is to be administered according to prespecified institutional guidelines. Radiation must be completed at least 21 days prior to registration.
◦Patients with hormone receptor positive breast cancer as defined above must receive at least 5 years of adjuvant hormonal therapy in the form of tamoxifen or an aromatase inhibitor, alone or in combination with ovarian suppression. (NOTE: for patients with ER and PR staining in less than 5% of cells, hormonal therapy for at least 5 years is strongly recommended but not required). Hormonal therapy can be initiated prior to or during protocol therapy.
3.Participants must be women
4.Age ≥ 18 years
5.Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
6.Comorbid Conditions
6.1 No history of other malignancy within the past 4 years, except for malignancies with a >95% likelihood of cure (e.g. non-melanoma skin cancer, papillary thyroid cancer, in situ cervical cancer). Patients cannot have metastatic breast or other cancer.
6.2 No diabetes mellitus currently treated with insulin or sulfonylureas.
6.3 No history of serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet.
6.4 No history of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
6.5 No prior bariatric surgery or planning to undergo this procedure within the next 2 years after study registration.
6.6 No comorbid conditions that would cause life expectancy of less than 5 years.
6.7 No history of psychiatric disorders that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder) or prevent the patient from giving informed consent.
7.Other
7.1 BMI ≥27 kg/m2 documented within 56 days prior to study registration. The most recent BMI obtained must be used for eligibility. If most recent BMI is <27 then the patient is not eligible to enroll.
7.2 Self-reported ability to walk at least 2 blocks (at any pace).
7.3 Not participating in another weight loss, physical activity or dietary intervention clinical trial. Co-enrollment in some trials involving pharmacologic therapy is allowed. Participants in both arms are also allowed to pursue weight loss and physical activity programs on their own, as long as these programs are not provided as part of a clinical trial.
7.4 Able to read and comprehend English. Eligibility is restricted to individuals who can comprehend and read English given that participation in the study will require the ability to read lifestyle intervention materials and communicate with a coach through 42 phone calls over 2 years. The study team plans to make the intervention available in Spanish in the future.

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Cancer
Open to Enrollment

DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors

This clinical trial studies nivolumab and ipilimumab in treating patients with rare tumors. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread.

Investigator:
Missak Haigentz, MD
S1609 | PHASE II

Sponsor:
Southwest Oncology Group

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Patients must have histologically confirmed rare cancer that did not have a match to a molecularly-guided therapy on EAY131 "National Cancer Institute (NCI)-Molecular Analysis for Therapy Choice (MATCH)" protocol or who progressed on molecularly-matched therapy and have no further molecularly-matched treatment recommendations per EAY131, "NCI-MATCH"
• Patients that do not qualify for one of the histologic cohorts may be considered for registration in the "Not Otherwise Categorized" Rare Tumors cohort with confirmation of at least one of the study chairs via email
• Patients that are determined to have a rare cancer with unknown primary site are eligible under cohort #32 (tumor of unknown primary [cancer of unknown primary; CuP]), provided that there is histologic documentation of metastatic malignancy with no discernible primary site identified from histopathologic review, physical exam and associated cross-sectional imaging of the chest, abdomen, and pelvis
• Patients must have progressed following at least one line of standard systemic therapy and there must not be other approved/standard therapy available that has been shown to prolong overall survival (i.e. in a randomized trial against another standard treatment or by comparison to historical controls); patients who cannot receive other standard therapy that has been shown to prolonged survival due to medical issues will be eligible, if other eligibility criteria are met; OR
◦ Patients for whose disease no standard treatment exists that has been shown to prolong overall survival
• Patients must have a diagnostic quality computed tomography (CT) scan or magnetic resonance imaging (MRI), performed within 28 days prior to registration, which demonstrates measurable disease, as defined in RECIST v. 1.1; all disease must be assessed and documented on the S1609 Baseline Tumor Assessment Form
• No other prior malignancy is allowed except for the following:
◦ Adequately managed stage I or II cancer from which the patient is currently in complete remission
◦ Any other cancer from which the patient has been disease free for one year
◦ Adequately managed stage I or II follicular thyroid or prostate cancer is also eligible, wherein patient is not required to be in complete remission
• Patients may have received prior anti-CTLA4 or other anti-PD-1/anti-PD-L1 therapy, not both, provided that it is completed >= 4 weeks prior to registration for monoclonal therapy, >= 8 weeks prior to registration if therapy involved immune-stimulatory monoclonal antibody (mAb)s, and >= 28 days for all other immunotherapy
• Patients who had prior immune-related adverse event (grade 3 or higher immune-related pneumonitis, hepatitis, colitis, endocrinopathy) with prior immunotherapy (e.g. cancer vaccine, cytokine, etc.) are not eligible
• Patients with clinically controlled thyroiditis or pituitary disorders on stable replacement therapy are eligible
• Patients are not eligible if they have had or are planned for solid organ transplant; patients who have received allogeneic hematopoietic stem cell transplant are eligible if:
◦ The transplant occurred at least 90 days prior to registration,
◦ Patient has no prior acute graft versus host disease (GVHD), and
◦ Within 48 hours of registration, patient demonstrates at least 90% engraftment, defined as: absolute neutrophil count (ANC) >= 500 mcl, measured over 3 consecutive days or 1 day with an ANC >= 1,000 mcl, or platelets >= 50,000 mcl measured, wherein the patient did not receive any platelet transfusions within 7 days prior to laboratory assessment
• Patients with autoimmune disease who are otherwise eligible must not have received steroid and immunosuppressive therapy within 28 days prior to registration
• Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy >= 28 days prior to registration and have stable disease at time of registration; metastatic brain parenchymal disease must have been treated and patient must be off steroids for 7 days prior to registration; patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to registration
• Patients must not currently be receiving any other investigational agents or any other systemic anti-cancer therapy (including radiation); in event patient recently received any other systemic anti-cancer therapy, patient must be off therapy at least 7 days prior to registration and any therapy-induced toxicity must have recovered to =< grade 1
• Patients must not have prior history of allergy or known hypersensitivity to nivolumab or ipilimumab
• Patients must have a Zubrod performance status of 0-2
• ANC >= 1,000/mcL
• Platelets >= 75,000/mcL
• Hemoglobin >= 8 g/dL
• Total bilirubin =< 2.0 x institutional upper limit of normal (IULN) or for documented/suspected Gilbert's disease, total bilirubin =< 3.0 x IULN
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 3 x IULN
• Serum creatinine =< 2.0 x IULN
• Creatinine clearance (CrCl) >= 50 mL/min., as estimated by the Cockcroft and Gault formula; estimated creatinine clearance is based on actual body weight
• Patients must have adequate thyroid function, as evidenced by either thyroid-stimulating hormone (TSH) or, free thyroxine (T4) serum tests demonstrating values within the normal range, within 28 days prior to registration; Note: TSH, with reflex T4 is allowable if per institutional standard; otherwise, both TSH and free-T4 must be obtained
• Patients must have adequate adrenal axis function, as evidenced by adrenocorticotropic hormone (ACTH) values within the normal ranges or cortisol levels within normal ranges (ante meridiem [AM] cortisol higher than the institutional lower limit of normal), within 28 days prior to registration
• Females of childbearing potential must have negative serum or urine pregnancy test 7 days prior to registration and agree to use birth control throughout study and for 23 weeks after completion of protocol therapy; patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
• Men of reproductive potential must have agreed to use birth control throughout the study and for 31 weeks after completion of protocol therapy; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (vasectomy); however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he is responsible for beginning contraceptive measures
• Patients must not have known active hepatitis B virus (HBV) or hepatitis virus (HCV) infection at time of registration; patients with HBV or HCV that have an undetectable viral load, or in the opinion of the treating investigator is well-controlled, are eligible
• Patients who are known to be human immunodeficiency virus (HIV)-positive at registration are eligible at the time of registration:
1. Cluster of differentiation (CD)4+ cell count greater or equal to 250 cells/mm^3
2. If patient is on antiretroviral therapy, there must be minimal interactions or overlapping toxicity of the antiretroviral therapy with the experimental cancer treatment; once daily combinations that use pharmacologic boosters may not be used
3. No history of non-malignancy acquired immunodeficiency syndrome (AIDS)-defining conditions other than historical low CD4+ cell counts
4 .Probable long-term survival with HIV if cancer were not present
• Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs, or corticosteroids with doses higher than prednisone 10mg or equivalent). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Autoimmune diseases include but are not limited to autoimmune hepatitis, inflammatory bowel disease, multiple sclerosis, vasculitis, or glomerulonephritis; patients with well-controlled systemic lupus erythematous or rheumatoid arthritis may be eligible after communication with the study chairs at S1609SC@swog.org; vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 3 years is permitted; short-term steroid premedication for contrast allergy is permitted
• Patients must not have any uncontrolled intercurrent illness including (not limited to): symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24 weeks prior to registration, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4 grade >= 2), known psychiatric illness that would limit study compliance, intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (>= grade 3)
◦ Note: Patients with history of CHF or patients who are deemed at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs should have an electrocardiogram (EKG) and echocardiogram (ECHO), as clinically indicated, at baseline and at the start of each cycle; patients who have evidence at baseline (or subsequently) of CHF, myocardial infarction (MI), cardiomyopathy, or myositis cardiac evaluation (NYHA I/II) should have additional consult by a cardiologist, including review of EKG, creatine phosphokinase (CPK), troponin, echocardiogram, as clinically indicated
• Patients must have amylase or lipase within =< 1.5 x IULN without symptoms of pancreatitis at registration, within 28 days prior to registration
• Patients must not have symptomatic interstitial lung disease or pneumonitis
• Patients must have fully recovered from any adverse effects of major surgery (to =< grade 1) at least 14 days prior to registration

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Cancer
Open to Enrollment

Molecular Analysis for Therapy Choice (MATCH)

This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists....

Investigator:
Paul Heller, MD

Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.

EAY131 | PHASE II

Sponsor:
Eastern Cooperative Oncology Group

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Women of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to registration; patients that are pregnant or breast feeding are excluded; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
◦ Has not undergone a hysterectomy or bilateral oophorectomy; or
◦ Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 months after completion of study; should a woman become pregnant or suspect while she or her partner is participating in this study, she should inform her treating physician immediately
• Patients must have histologically documented solid tumors or histologically confirmed diagnosis of lymphoma or multiple myeloma requiring therapy and meet one of the following criteria:
◦ Patients must have progressed following at least one line of standard systemic therapy and there must not be other approval/standard therapy available that has been shown to prolong overall survival (i.e. in a randomized trial against another standard treatment or by comparison to historical controls); patients who cannot receive other standard therapy that has been shown to prolong overall survival due to medical issues will be eligible, if other eligibility criteria are met; if the patient is currently receiving therapy, the clinician must have assessed that the current therapy is no longer benefitting the patient prior to enrolling on MATCH, regardless of whether it is considered standard OR
◦ Patients for whose disease no standard treatment exists that has been shown to prolong overall survival
◦ NOTE: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; adequately treated stage I or II cancer from which the patient is currently in complete remission; any other cancer from which the patient has been disease-free for 5 years
• Patients must have measurable disease
• Patients must meet one of the following criteria:
◦ Patients must have tumor amenable to image guided or direct vision biopsy and be willing and able to undergo a tumor biopsy for molecular profiling; patients with multiple myeloma other than plasmacytomas are to have a bone marrow aspirate to obtain tumor cells; biopsy must not be considered to be more than minimal risk to the patient
◾ NOTE: Registration to screening steps (Step 0, 2, 4, 6) must occur after stopping prior therapy; there is no specific duration for which patients must be off treatment prior to registration to the relevant screening step (and subsequently, the biopsy), as long as all other eligibility criteria are met OR
◦ Patient will be undergoing a procedure due to medical necessity during which the tissue may be collected
◾ NOTE: Registration to screening steps (Step 0, 2, 4, 6) must occur after stopping prior therapy; there is no specific duration for which patients must be off treatment prior to registration to the relevant screening step (and subsequently, the biopsy), as long as all other eligibility criteria are met OR
◦ Formalin-fixed paraffin-embedded tumor tissue block(s) are available for submission following pre-registration (not applicable for bone marrow aspirate specimens); criteria for the submission of formalin-fixed paraffin-embedded (FFPE) tissue are:
◾ Tissue must have been collected within 6 months prior to pre-registration to Step 0
◾ Patient may receive treatment after tissue collection; however, lack of response must be documented prior to Step 1; the following restrictions apply:
◾ Enrollment onto another investigational study is not permitted
◾ Intervening therapy that constitutes a new, molecularly targeted therapy is not permitted; please note, immunotherapy is not considered molecularly targeted
◾ Continuation of an agent/regimen for which disease progression has been observed prior to biopsy is permitted, including targeted therapy
◾ A new immunotherapy regimen is permitted; but, lack of response must also be documented prior to registration to Step 0
◾ Formalin-fixed paraffin-embedded tumor tissue block(s) must meet the minimum requirements OR
◦ Results from one of the designated outside laboratories indicate a "rare variant" that is an actionable mutation of interest (aMOI) for specific designated rare variant subprotocols; the following requirements apply:
◾ The outside laboratory notified the site that patient may be a potential candidate for MATCH due to a detected "rare variant"
◾ Patients with an applicable "rare variant" must be able to meet the eligibility criteria for the appropriate subprotocols within 4 weeks following entry on the EAY131 Step 0 screening step
◾ Registration to Step 0 must occur after stopping prior systemic anti-cancer therapy; there is no specific duration for which patients must be off treatment prior to registration to Step 0, as long as all eligibility criteria are met
◾ NOTE: Other potential aMOIs that would be eligibility criteria for NON RARE arms, as determined by the above laboratories, are not applicable for direct treatment assignment on MATCH
◾ NOTE: Tumor tissue for the confirmation of "rare variant" by the MATCH assay is to be submitted, preferably from the same time of collection as that evaluated by the designated outside laboratory
• Patient must not require the use of full dose coumarin-derivative anticoagulants such as warfarin; low molecular weight heparin is permitted for prophylactic or therapeutic use; factor X inhibitors are permitted
◦ NOTE: Warfarin may not be started while enrolled in the EAY131 study
◦ Stopping the anticoagulation for biopsy should be per site standard operating procedure (SOP)
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =< 1 and a life expectancy of at least 3 months
• Patients must not currently be receiving any other investigational agents
• Patients must not have any uncontrolled intercurrent illness including, but not limited to:
◦ Symptomatic congestive heart failure (New York Heart Association [NYHA] classification of III/IV)
◦ Unstable angina pectoris or coronary angioplasty, or stenting within 6 months prior to registration to Step 0, 2, 4, 6
◦ Cardiac arrhythmia (ongoing cardiac dysrhythmias of National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4 grade >= 2)
◦ Psychiatric illness/social situations that would limit compliance with study requirements
◦ Intra-cardiac defibrillators
◦ Known cardiac metastases
◦ Abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram (ECHO) (as clinically indicated); (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study
◦ NOTE: To receive an agent, patient must not have any uncontrolled intercurrent illness such as ongoing or active infection; patients with infections unlikely to be resolved within 2 weeks following screening should not be considered for the trial
• Patients must be able to swallow tablets or capsules; a patient with any gastrointestinal disease that would impair ability to swallow, retain, or absorb drug is not eligible
• Patients who are human immunodeficiency virus (HIV)-positive are eligible if:
◦ CD4+ cell count greater or equal to 250 cells/mm^3
◦ If patient is on antiretroviral therapy, there must be minimal interactions or overlapping toxicity of the antiretroviral therapy with the experimental cancer treatment; for experimental cancer therapeutics with CYP3A/4 interactions, protease inhibitor therapy is disallowed; suggested regimens to replace protease inhibitor therapy include dolutegravir given with tenofovir/emtricitabine; raltegravir given with tenofovir and emtricitabine; once daily combinations that use pharmacologic boosters may not be used
◦ No history of non-malignancy acquired immune deficiency syndrome (AIDS)-defining conditions other than historical low CD4+ cell counts
◦ Probable long-term survival with HIV if cancer were not present
• Any prior therapy, radiotherapy (except palliative radiation therapy of 30 gray [Gy] or less), or major surgery must have been completed >= 4 weeks prior to start of treatment; all adverse events due to prior therapy have resolved to a grade 1 or better (except alopecia and lymphopenia) by start of treatment; palliative radiation therapy must have been completed at least 2 weeks prior to start of treatment; the radiotherapy must not be to a lesion that is included as measurable disease
◦ NOTE: Prostate cancer patients may continue their luteinizing hormone-releasing hormone (LHRH) agonist
◦ NOTE: Patients may receive non-protocol treatment after biopsy (if clinically indicated) until they receive notification of results; however, lack of response must be documented prior to registration to Step 1; new non-protocol treatment will NOT be permitted as intervening therapy after registration to Step 0; the decision to stop the intervening non-protocol treatment will be left up to the treating physician if patient has an aMOI; however, patients will need to be off such therapy for at least 4 weeks before receiving any MATCH protocol treatment
◦ NOTE: For patients entering the study via a designated outside laboratory, no intervening systemic non-protocol treatment is permitted after Step 0 registration; all other eligibility requirements still apply to these patients, including the washouts for prior therapy noted above in this section, the time restrictions outlined, and the eligibility criteria for the intended subprotocol
• Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy >= 4 weeks prior to start of treatment
• Patients must have discontinued steroids >= 1 week prior to registration to Step 0 and remain off steroids thereafter, except as permitted (see below); patients with glioblastoma (GBM) must have been on stable dose of steroids, or be off steroids, for one week prior to registration to treatment (Step 1, 3, 5, 7)
◦ NOTE: The following steroids are permitted (low dose steroid use is defined as prednisone 10 mg daily or less, or bioequivalent dose of other corticosteroid):
◾ Temporary steroid use for computed tomography (CT) imaging in setting of contrast allergy
◾ Low dose steroid use for appetite
◾ Chronic inhaled steroid use
◾ Steroid injections for joint disease
◾ Stable dose of replacement steroid for adrenal insufficiency or low doses for non-malignant disease
◾ Topical steroid
◾ Steroids required to manage toxicity related to study treatment, as described in the subprotocols
◾ Steroids required as pre- or post-chemotherapy medication for acceptable intervening chemotherapy
◾ NOTE: Steroids must be completed alongside last dose of chemotherapy
• Leukocytes >= 3,000/mcL
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL
• NOTE: Patients with documented bone marrow involvement by lymphoma are not required to meet the above hematologic parameters, but must have a platelet count of at least 75,000/mcL and neutrophil count of at least 1,000/mcL
• Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) (unless documented Gilbert's syndrome, for which bilirubin =< 3 x institutional ULN is permitted)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional ULN (up to 5 times ULN in presence of liver metastases)
• Creatinine clearance >= 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
• Patients must have an electrocardiogram (ECG) within 8 weeks prior to registration to screening step and must meet the following cardiac criteria:
◦ Resting corrected QT interval (QTc) =< 480 msec
◾ NOTE: If the first recorded QTc exceeds 480 msec, two additional, consecutive ECGs are required and must result in a mean resting QTc =< 480 msec; it is recommended that there are 10-minute (+/- 5 minutes) breaks between the ECGs
◦ The following only need to be assessed if the mean QTc > 480 msec
◾ Check potassium and magnesium serum levels
◾ Correct any identified hypokalemia and/or hypomagnesemia and may repeat ECG to confirm exclusion of patient due to QTc
◾ For patients with heart rate (HR) 60-100 beats per minute (bpm), no manual read of QTc is required
◾ For patients with baseline HR < 60 or > 100 bpm, manual read of QT by trained personnel is required, with Fridericia correction applied to determine QTc
◾ Patient must not have hypokalemia (value < institutional lower limit of normal)
◦ No factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval
◾ NOTE: Patient must be taken off prohibited medication prior to registration to the screening step (Step 0, 2, 4, 6) and remain off these medications thereafter, unless permitted on a subprotocol for the management of treatment related toxicity; patient must be off the drug for at least 5 half-lives prior to registration to the treatment step (Step 1, 3, 5, 7); the medication half-life can be found in the package insert for Food and Drug Administration (FDA) approved drugs

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Cerebral Hemorrhage
Open to Enrollment

MIND: A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage

The primary objective of this multicenter randomized controlled study is to compare the safety and efficacy of minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device to best medical management for the treatment of intracerebral hemorrhage...

Investigator:
Paul Saphier, MD

(ICH).

MIND

Sponsor:
Penumbra, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Patient age ≥ 18 and ≤ 80
2. Supratentorial ICH of volume ≥ 20 and ≤ 80 cc (measured using A x B X C/2 method)
3. Hemostasis (hemorrhage increase of < 5 cc as confirmed by 2 CT/MR taken a minimum of 6 hours apart)
4. NIHSS ≥ 6
5. Presenting GCS ≥ 5 and ≤ 15
6. Historical mRS 0 or 1
7. Symptom onset < 24 hours prior to initial CT
8. MIS must be initiated within 72 hours of ictus/bleed
9. SBP must be < 180 mmHg and controlled at this level for at least 6 hours

Exclusion Criteria:
1. Imaging
1. Expanding hemorrhage on final screening CT/MR scan
2. "Arterial Spot sign" identified on CTA (may perform additional CTA(s) every 6 hours to demonstrate resolution)
3. Hemorrhagic lesion such as a vascular malformation (cavernous malformation, AVM etc.), aneurysm, and/or neoplasm
4. Hemorrhagic conversion of an underlying ischemic stroke
5. Infratentorial hemorrhage
6. Associated intra-ventricular hemorrhage requiring treatment for IVHrelated mass effect or shift due to trapped ventricle (EVD for ICP management is allowed)
7 .Midbrain extension/involvement
8. Absolute contraindication to CTA, conventional angiography and MRA
2. Coagulation Issues
1. Absolute requirement for long-term anti-coagulation (e.g., Mechanical valve replacement (bio-prostatic valve is permitted), high risk atrial fibrillation)
2. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
3. Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction
4. INR > 1.4, elevated prothrombin time or activated partial thromboplastin time (aPTT), which cannot be corrected or otherwise accounted for (i.e., lupus anti-coagulant)
3. Patient Factors
1. Traumatic ICH
2. High risk atrial fibrillation (e.g., mitral stenosis with atrial fibrillation) and/or symptomatic carotid stenosis
3. Requirement for emergent surgical decompression or uncontrolled ICP after EVD
4. Unable to obtain consent from patient or legally authorized representative (LAR; for patients without competence)
5. Pregnancy or positive pregnancy test (either serum or urine). Women of child-bearing potential must have a negative pregnancy test prior to enrollment
6. Evidence of active infection indicated by fever > 100.7 °F/ 38.2°C and/or open draining wound at the time of randomization
7. Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days
8. Based on investigator's judgement, patient is unwilling or unable to comply with protocol follow up appointment schedule
9. Active drug or alcohol use or dependence that, in the opinion of the site investigator would interfere with adherence to study requirements
10. Currently participating in another interventional (drug, device, etc) clinical trial. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.

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Cerebral Hemorrhage
Open to Enrollment

SMART - A Prospective, Multicenter Study Assessing the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil

The primary objective of this study is to gather post market data on the Penumbra SMART Coil™ System in the treatment of intracranial aneurysms and other malformations.

Investigator:
Paul Saphier, MD
SMART | PHASE IV

Sponsor:
Penumbra, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: Child, Adult, Senior
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
Patients enrolled in this study must sign Informed Consent and be treated according to the cleared indications for the Smart, PC 400, and POD, which include the embolization of:
• Intracranial aneurysms
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae

Exclusion Criteria:
• Life expectancy less than one year
• Smart, PC 400, or POD account for less than 75% of total number of coils opened
• Participation in another clinical investigation that could confound the evaluation of the study device

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Colon Cancer
Open to Enrollment

A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients With Stage 0-III Colon or Rectal Cancer, Phase III - Preventing Adenomas of the Colon With Eflornithine and Sulindac (PACES)

The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon cancer.

Investigator:
Angela Alistar, MD
S0820 | PHASE III

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
•History of Stage 0-III colon or rectal cancer with primary resection 1 year previously
•Post-operative colonoscopy and CT scans of chest, abdomen & pelvis showing no evidence of disease
•Must not have cardiovascular risk factors including unstable angina, history of myocardial infarction, or cerebrovascular accident, coronary artery bypass surgery, or NY Heart Assoc Class III or IV heart failure.
•Patients must not have known uncontrolled hyperlipidemia (defined as LDL-C >/= 190 mg/dL or triglycerides >/= 500 mg/dL within the past 3 years or uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg) within 28 days prior to registration
•At least 30 days from completion of adjuvant chemo and RT.
•Presence of gastroesophageal reflux disease acceptable if controlled with medications
•Not receiving or planning to receive concomitant corticosteroids,nonsteroidal anti-inflammatory drugs(NSAIDs), nor anticoagulants. Maximum aspirin dose
◦100 mg per day or ≤ two 325 mg tablets per week.
•Able to swallow oral medications
•Laboratory: WBC ≥ 4.0 x 103/mcL, platelets ≥ 100,000/mcL and hemoglobin > 11.0 g/dL. Serum bilirubin ≤ 2.0 mg/dL and AST (SGOT) or ALT(SGPT) ≤ 2 x IULN. Serum creatinine ≤ 1.5 x IULN
•Zubrod PS 0-1, 18 years of age or older
•Will not participate in any other clinical trial for the treatment or prevention of cancer unless off protocol treatment, on follow-up phase only
•Offered opportunity to participate in blood specimen banking

Exclusion Criteria:
•History of colon resection > 40 cm
•Mid-low rectal cancer
•Recurrent or metastatic disease
•High cardiovascular risk; Uncontrolled hypertension
•Planned radiation therapy or additional chemotherapy
•Documented history of gastric/duodenal ulcer within last 12 months and/or current treatment or active symptoms of gastric/duodenal ulcer
•Known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease
•≥ 30 dB uncorrectable hearing loss for age of any of the five tested frequencies on prestudy audiogram
•Known hypersensitivity to sulindac or excipient byproducts. Previous asthma, urticaria, or allergic-type reaction to aspirin or other NSAIDs
•Significant medical or psychiatric condition that would preclude study completion (8 years)
•No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for > 5 years
•Pregnant or nursing women. Women/men of reproductive potential must agree to use effective contraception

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Colon Cancer
Open to Enrollment

Randomized Trial of Standard Chemotherapy Alone or Combined With Atezolizumab as Adjuvant Therapy for Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair

This randomized phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair....

Investigator:
Angela Alistar, MD

Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy with atezolizumab may work better than combination chemotherapy alone in treating patients with colon cancer.

A021502 | PHASE III

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Histologically proven stage III colon adenocarcinoma (any T [Tx, T1, T2, T3, or T4], N1-2M0; includes N1C)
• Presence of deficient (d) DNA mismatch repair (dMMR); MMR status must be assessed by immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of one or more proteins indicates dMMR; dMMR may be determined either locally or by site-selected reference lab; Note: loss of MLH1 and PMS2 commonly occur together; formalin-fixed paraffin-embedded (FFPE) tumor tissue is required for subsequent retrospective central confirmation of dMMR status
• Patients with testing that did not show dMMR (loss of MMR protein) are not eligible to participate; patients whose tumors show MSI-H by polymerase chain reaction (PCR)-based assay are not eligible to participate unless they also have MMR testing by IHC and are found to have dMMR (i.e. loss of one or more MMR proteins)
• Patients who are known to have Lynch syndrome and have been found to carry a specific germline mutation in an MMR gene (MLH1, MSH2, MSH6, PMS2) are eligible to participate
• Tumors must have been completely resected; in patients with tumor adherent to adjacent structures, en bloc R0 resection must be documented; positive radial margins are not excluded as long as en bloc resection was performed; proximal or distal margin positivity is excluded
• Entire tumor must be in the colon (rectal involvement is an exclusion); surgeon confirmation that entire tumor was located in the colon is required only in cases where it is important to establish if the tumor is a colon versus (vs.) rectal primary
• Based upon the operative report and other source documentation, the location of the primary tumor will be categorized as proximal or distal to the splenic flexure (distal includes), and further categorization will be as follows: cecum/ascending, descending, sigmoid colon, or rectosigmoid colon
• No evidence of residual involved lymph node disease or metastatic disease at the time of registration based on clinician assessment of imaging; the treating physician will determine if incidental lesions on imaging require workup to exclude metastatic disease; if based on review of images, the treating physician determines the patient to be stage III, then the patient is eligible
• No prior medical therapy (chemotherapy, immunotherapy, biologic or targeted therapy) or radiation therapy for colon cancer except for one cycle of mFOLFOX6
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• For women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required; a female of childbearing potential is a sexually mature female who:
◦ Has not undergone a hysterectomy or bilateral oophorectomy; or
◦ Has not been naturally postmenopausal for at least 12 consecutive months (i.e. has had menses at any time in the preceding 12 consecutive months)
• Absolute neutrophil count (ANC) >= 1500 mm^3
• Platelet count >= 100,000 mm^3; platelets >= 75,000 required for patients who received cycle 1 of mFOLFOX6 prior to registration
• Creatinine =< 1.5 x upper limit of normal (ULN) or
• Calculated creatinine clearance >= 45 mL/min by Cockcroft-Gault equation
• Total bilirubin =< 1.5 x upper limit of normal (ULN) except in the case of Gilbert disease
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
• Thyroid-stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH, if free T4 is normal and patient is clinically euthyroid, patient is eligible
• No active known autoimmune disease, including colitis, inflammatory bowel disease (i.e. ulcerative colitis or Crohn's disease), rheumatoid arthritis, panhypopituitarism, adrenal insufficiency
• No known active hepatitis B or C
◦ Active hepatitis B can be defined as:
◾Hepatitis B virus surface antigen (HBsAg) detectable for > 6 months;
◾Serum hepatitis B virus (HBV) DNA 20,000 IU/ml (105 copies/ml); lower values 2,000-20,000 IU/ml (104-105 copies/ml) are often seen in hepatitis B virus e antigen (HBeAg)-negative chronic hepatitis B
◾Persistent or intermittent elevation in ALT/AST levels
◾Liver biopsy showing chronic hepatitis with moderate or severe necroinflammation
◦ Active hepatitis C can be defined as:
◾Hepatitis C antibody (AB) positive AND
◾Presence of hepatitis C virus (HCV) RNA
• Excluded if known active pulmonary disease with hypoxia defined as:
◦ Oxygen saturation < 85% on room air, or
◦ Oxygen saturation < 88% despite supplemental oxygen
• No grade >= 2 peripheral motor or sensory neuropathy
• Patients positive for human immunodeficiency virus (HIV) are eligible only if they meet all of the following:
◦ A stable regimen of highly active anti-retroviral therapy (HAART)
◦ No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
◦ A CD4 count above 250 cells/mcL, and an undetectable HIV viral load on standard PCR-based tests
• No other planned concurrent investigational agents or other tumor directed therapy (chemotherapy, radiation) while on study
• No systemic daily treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days of registration
• No known history of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins
• No known hypersensitivity to Chinese hamster ovary (CHO) cell products or any component of the atezolizumab formulation
• No known allergy to 5-fluorouracil, oxaliplatin, or leucovorin

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Colorectal Cancer
Open to Enrollment

A Phase II/III Trial of Neoadjuvant FOLFOX With Selective Use of Combined Modality Chemoradiation Versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection With Total Mesorectal Excision (PROSPECT)

The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective...

Investigator:
Sophie Morse, MD

use of the standard treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely to treat patients with advanced colorectal cancer.

N1048 | PHASE II/III

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Registration Inclusion Criteria:
1. Age ≥ 18 years at diagnosis
2. Diagnosis of rectal adenocarcinoma
3. Radiologically measurable or clinically evaluable disease as defined in the protocol
4. ECOG Performance Status (PS): 0, 1 or 2
5. For this patient, the standard treatment recommendation in the absence of a clinical trial would be combined modality neoadjuvant chemoradiation followed by curative intent surgical resection
6. Candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy according to the primary surgeon
7. Primary surgeon is credentialed or is willing to be credentialed in Total Mesorectal Excision (TME), which entails submission of photos of a single TME specimen either before enrolling the first patient or by using the surgeon's 1st accrued case.
8. Clinical Stage: T2N1, T3N0, T3N1.
◦ N2 disease is to be estimated as four or more lymph nodes that are ≥ 10 mm.
◦ Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon, CT or PET/CT scan of the chest/abdomen/pelvis and either a pelvic MRI or an ultrasound (ERUS). If a pelvic MRI is peformed, it is acceptable to perform CT of the chest/abdomen, ommitting CT imaging of the pelvis.
9. The following laboratory values obtained ≤ 28 days prior to registration:
◦ Absolute neutrophil count (ANC) ≥ 1500/mm^3
◦ Platelet count ≥ 100,000/mm^3
◦ Hemoglobin > 8.0 g/dL
◦ Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
◦ SGOT (AST) ≤ 3 x ULN
◦ SGPT (ALT) ≤ 3 x ULN
◦ Creatinine ≤1.5 x ULN
10. Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
11. Patient of child-bearing potential is willing to employ adequate contraception
12. Provide informed written consent
13. Willing to return to enrolling medical site for all study assessments

Registration Exclusion Criteria:
1. Clinical T4 tumors
2. Primary surgeon indicates need for abdominoperineal (APR) at baseline
3. Evidence that the tumor is adherent to or invading the mesorectal fascia on imaging studies such that the surgeon would not be able to perform an R0 resection (one with negative margins)
4. Tumor is causing symptomatic bowel obstruction (patients who have had a temporary diverting ostomy are eligible).
5. Chemotherapy within 5 years prior to registration. Hormonal therapy is allowable if the disease free interval is ≥ 5 years.
6. Any prior pelvic radiation
7. Other invasive malignancy ≤ 5 years prior to registration. Exceptions are colonic polyps, non-melanoma skin cancer, ductal carcinoma in situ, bladder carcinoma in situ, or carcinoma-in-situ of the cervix.
8. Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects.
◦ Pregnant women
◦ Nursing women
◦ Men or women of childbearing potential who are unwilling to employ adequate contraception
9. Co-morbid illnesses or other concurrent disease which, in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.

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Cystic Fibrosis
Open to Enrollment

A Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis

This is a first-in-human and proof-of-concept study of VX-445. The study includes 5 parts. Parts A, B, and C will be conducted in healthy subjects. Parts D and E will be conducted in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation...

Investigator:
Stanley Fiel, MD

of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).

VX16-445-001 | PHASE I/II

Sponsor:
Vertex Pharmaceuticals Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes

Key Inclusion Criteria:

Parts A, B, and C:
• Female subjects must be of non-childbearing potential.
• Between the ages of 18 and 55 years, inclusive.
• Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and a total body weight >50 kg

Parts D and E:
• Body weight ≥35 kg.
• Subjects must have an eligible CFTR genotype:
◦ Part D: Heterozygous for F508del and an MF mutation (F/MF)
◦ Part E: Homozygous for F508del (F/F)
• FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height.

Key Exclusion Criteria:

Parts A, B, and C:
• Any condition possibly affecting drug absorption.
• History of febrile illness within 14 days before the first study drug dose.
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Parts D and E:
• History of clinically significant cirrhosis with or without portal hypertension.
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• Lung infection with organisms associated with a more rapid decline in pulmonary status.
• History of solid organ or hematological transplantation.
Other protocol defined Inclusion/Exclusion criteria may apply.

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Cystic Fibrosis
Open to Enrollment

A Phase III, Randomized, Double-blind, Placebo-controlled Study of AeroVanc for the Treatment of Persistent Methicillin-resistant Staphylococcus Aureus Lung Infection in Cystic Fibrosis Patients

This study is a multi-center, randomized phase III study to evaluate the clinical effectiveness of AeroVanc in persistent MRSA in patients with Cystic Fibrosis.

Investigator:
Stanley Fiel, MD
SAV005-04 | PHASE III

Sponsor:
Savara Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 6 Years and older (Child, Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Subjects ≥ 6 years of age at time of Informed Consent Form (ICF) or Assent Form signing.
2. Confirmed diagnosis of CF, determined by having clinical features consistent with the CF phenotype, plus one of the following:
1. Positive sweat chloride test (value ≥ 60 mEq/L),
2. Genotype with 2 mutations consistent with CF (ie, a mutation in each of the cystic fibrosis transmembrane conductance regulator [CFTR] genes).
3. Positive sputum culture or a throat swab culture for MRSA at Screening.
4. In addition to the Screening sample, have at least 2 prior sputum or throat swab cultures positive for MRSA, of which at least 1 sample is more than 6 months prior to Screening. At least 50% of all cultures (sputum or throat swab culture) collected over the previous 1 year must have tested positive for MRSA.
5. Forced expiratory volume in 1 second (FEV1) ≥ 30% and ≤ 90% of predicted that is normal for age, gender, race, and height, using the Global Lung Function Initiative (GLI) equation.
6. At least 1 episode of acute pulmonary infection treated with non-maintenance antibiotics within 12 months prior to the Baseline visit. (Initiation of treatment with intermittent inhaled anti-Pseudomonal therapy will not qualify as treatment with non-maintenance antibiotics).
7. If female of childbearing potential, an acceptable method of contraception must be used during the study and must be combined with a negative pregnancy test obtained during Screening; male subjects who are non-sterile (ie, male who has not been sterilized by vasectomy for at least 6 months) must be willing to use an acceptable method of contraception during the study.

For purposes of this study, the Sponsor defines "acceptable methods of contraception" as:
1. Oral birth control pills administered for at least 1 monthly cycle prior to administration of the study drug.
2. A synthetic progestin implanted rod (eg, Implanon®) for at least 1 monthly cycle prior to the study drug administration but not beyond the 4th successive year following insertion.
3. Intrauterine devices (IUDs), inserted by a qualified clinician for at least 1 monthly cycle prior to study drug administration.
4. Medroxyprogesterone acetate (eg, Depo-Provera®) administered for a minimum of 1 monthly cycle prior to administration of the study drug and continuing through 1 month following study completion.
5. Hysterectomy or surgical sterilization.
6. Abstinence.
7. Double barrier method (diaphragm with spermicidal gel or condoms with contraceptive foam).
8. Able and willing to comply with the protocol, including availability for all scheduled study visits and able to perform all techniques necessary to use the AeroVanc inhaler and measure lung function.
9. Agree not to smoke during any part of the clinical trial (Screening visit through end of study).
10. Subjects with a P. aeruginosa co-infection must either be stable on a regular suppression regimen of inhaled antibiotics or must be, in the opinion of the Investigator, stable despite the lack of such treatment.

Exclusion Criteria:
1. Use of anti-MRSA treatments prescribed as maintenance therapy (intravenous [IV] or inhaled treatment within 28 days; oral treatment within 14 days) during the Screening period, prior to the Baseline visit.
2. Use of non-maintenance antibiotic for pulmonary infection or extrapulmonary MRSA infection (IV or inhaled antibiotic within 28 days; oral antibiotic within 14 days) during the Screening period, prior to the Baseline visit.
3. History of previous allergies or sensitivity to vancomycin, or other component(s) of the study drug or placebo except for a history of red-man syndrome.
4. Inability to tolerate inhaled products.
5. First time sputum culture or throat swab culture yielding B. cepacia, or nontuberculous Mycobacteria in the previous 6 months to Screening.
6. History of lung or other solid organ transplantation or currently on the list to receive lung or other solid organ transplantation.
7. Resistance to vancomycin at Screening (vancomycin resistant Staphylococcus aureus [VRSA], or vancomycin intermediate resistant Staphylococcus aureus [VISA], with minimum inhibitory concentration [MIC] ≥ 8 mcg/mL).
8. Oral corticosteroids in doses exceeding 10 mg prednisone per day or 20 mg prednisone every other day, or equipotent doses of other corticosteroids.
9. Changes in antimicrobial, bronchodilator, anti-inflammatory or corticosteroid medications within 14 days prior to the Baseline visit.
10. Abnormal laboratory findings or other findings or medical history at Screening that, in the Investigator's opinion, would compromise the safety of the subject or the quality of the study data.
11. Inability to tolerate inhalation of a short acting beta2 agonist
12. SpO2 <90% at Screening.
13. Changes in physiotherapy technique or physiotherapy scheduled within 1 week of the Baseline visit.
14. Administration of any investigational drug or device within 4 weeks prior to the Screening visit and during the study
15. Female with positive pregnancy test result during Screening, pregnant (or intends to become pregnant), lactating or intends to breastfeed during the study.
16. Renal insufficiency, defined as creatinine clearance < 50 mL/min using the Cockcroft-Gault equation for adults or Schwartz equation for children at the Screening visit.
17. Abnormal liver function, defined as ≥ 4x upper limit of normal (ULN), of serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT), or known cirrhosis at Screening.
18. Diagnosed with clinically significant hearing loss.
19. History of positive result for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
20. Planned hospitalizations for prophylaxis antibiotic treatment within 28 days prior to Baseline visit or during the double-blind period (Period 1).

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Cystic Fibrosis
Open to Enrollment

Standardized Treatment of Pulmonary Exacerbations II (STOP2)

This randomized, controlled, open-label study is designed to evaluate the efficacy and safety of differing durations of IV treatment, given in the hospital or at home for a pulmonary exacerbation in adult patients with CF.

Investigator:
Rebecca Griffith
STOP2 | PHASE IV

Sponsor:
Cystic Fibrosis Foundation Therapeutics

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Male or female ≥18 years of age at Visit 1
• Documentation of a CF diagnosis
• Enrolled in the Cystic Fibrosis Foundation National Patient Registry (CFFNPR) prior to Visit 1 (US sites only)
• At the time of Visit 1, there is a plan to initiate IV antibiotics for a pulmonary exacerbation
• Performed spirometry at Visit 1 and Visit 2 and willing to perform spirometry at Visit 3
• Completed the CRISS questionnaire at Visit 1 and Visit 2 and willing to complete the Cystic Fibrosis Respiratory Symptoms Diary (CFRSD) questionnaire at Visit 3
• Willing to adhere to a specific treatment duration determined by initial response to treatment and subsequent randomization
• Willing to return for follow up Visit 3
• Written informed consent obtained from the subject or subject's legal representative

Exclusion Criteria:
• Previous randomization in this study
• Treatment with IV antibiotics in the 6 weeks prior to Visit 1
• Admission to the intensive care unit for current pulmonary exacerbation in the two weeks prior to Visit 2, unless admission was due to a desensitization protocol
• Pneumothorax in the two weeks prior to Visit 2
• Primary diagnosis for current hospitalization is unrelated to worsening lower respiratory symptoms (e.g., pulmonary clean out, distal intestinal obstruction syndrome (DIOS), sinusitis)
• Massive hemoptysis defined as > 250 cc in a 24 hour period or 100 cc/day over 4 consecutive days occurring in the two weeks prior to Visit 2
• Current pulmonary exacerbation thought to be due to allergic bronchopulmonary aspergillosis (ABPA)
• At Visit 1, receiving ongoing treatment with a duration of more than 2 weeks with prednisone equivalent to >10mg/day
• History of solid organ transplantation
• Receiving antimicrobial therapy to treat non-tuberculous mycobacterium (e.g., M. abscessus, M. avium complex) in the two weeks prior to Visit 2

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Diabetes
Completed

A Multicenter, Randomized, Partial-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus

This is a multicenter, randomized, partial-blinded, five-arm, placebo-controlled study of human plasma-derived alpha1-proteinase inhibitor (alpha1-PI) in children (ages 6-11 years old) and teens/adults (ages 12-35 years old) with new onset Type 1 Diabetes...

Mellitus (T1DM). The purpose of this study is to evaluate the safety and efficacy of four dosing regimens of human plasma-derived alpha1-PI in T1DM.

GTI1302 | PHASE II

Sponsor:
Grifols Inc

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 6 Years to 35 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
•Diagnosis of T1DM according to the ADA criteria.
•Current use of injected insulin therapy and one positive result on testing for any of the following antibodies (If not currently on insulin therapy, must have positive result for at least two of the below antibodies):
◦Anti-islet-cell antibodies (islet cell antigen 512, insulinoma associated protein 2),
◦Anti-glutamic acid decarboxylase antibodies, or
◦Anti-insulin antibodies (unless received insulin therapy for > 7 days).

•Body Mass Index (BMI) ≤ 25 kg/m2 for adults (≥ 20 years of age) OR < 85th percentile in accordance with the Centers for Disease Control BMI assessment for children and teens (2 through 19 years old).

Exclusion Criteria:
•History of or current diabetic retinopathy, neuropathy, or nephropathy.
•Known thrombophilia or history of thrombosis.
•Malignant disease (including malignant melanoma; however, other forms of skin cancer are allowed) within five years of randomization.
•Active Hepatitis A virus, Hepatitis B virus, Hepatitis C virus, or Human Immunodeficiency Virus infection.
•History of anaphylaxis or severe systemic response to any plasma-derived alpha1-PI preparation or other blood product(s).
•Known selective or severe Immunoglobulin A deficiency.
•Elevated liver enzymes (aspartate transaminase, alanine aminotransferase, and alkaline phosphatase) equal to or greater than 2.5 times the upper limit of normal.
•Therapy with exenatide or any other agents that stimulate pancreatic β cell regeneration or insulin secretion, or any antidiabetic agents (oral or parenteral) other than insulin within three months prior to screening.
•Use of omega-3 fatty acid supplements, including fish oil, within seven days prior to screening.
•Current or planned therapy with inhaled insulin, if it becomes available.
•Use of systemic steroids above a stable dose equivalent to 5 mg/day prednisone (e.g., 10 mg every 2 days) within the 4 weeks prior to randomization. It is recommended to maintain the same dose throughout the study.
•Treatment with immunosuppressants or cytostatic agents within 6 months of randomization.

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Fracture
Open to Enrollment

The Treatment of Type I Open Fractures in Pediatrics: Evaluating the Necessity of Formal Irrigation and Debridement

Open fractures are frequently encountered in orthopaedics. Treatment usually calls for a formal, operative procedure in which the bone is exposed, foreign tissue is debrided and the wound is irrigated. While this is the current standard of care, not all open...

Investigator:
Barbara Minkowitz, MD

fractures are equal. In retrospective studies, centers are reporting less aggressive operative management for open fractures may result in equal results without the time and expense of the operative theater. The investigators propose a prospective, randomized trial of children with type I open fractures to evaluate whether formal operative treatment is necessary. The investigators' hypothesis is that minor open fractures can be safely treated in the emergency room with irrigation, closed reduction and home antibiotics without an increased risk of infection or other complications.

PROOF | PHASE I/II

Sponsor:
Ann & Robert H. Lurie Children's Hospital of Chicago

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 3 Years to 14 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria


Inclusion Criteria:
• open fracture amenable to treatment by closed reduction
• low energy mechanism of injury (e.g., falls from less than 10 feet, bicycle accidents)
• wound less than 1cm in length and the bone not visualized through the skin

Exclusion Criteria:
• open fracture not amenable to treatment by closed reduction
• open fracture that would typically require operative reduction and fixation
• high energy mechanism of injury (e.g., struck by vehicle, motor vehicle accidents, fall from height greater than 10 feet)
• wound greater than 1cm in length
• gross contamination of wound
• open fractures involving hands or feet (the current standard of care to treat open injuries involving hands or feet is only emergency room management)

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Genetics
Open to Enrollment

A Four-Part, Phase 3, Randomized, Double-Blind, Placebo- Controlled, Four-Arm, Discontinuation Study to Evaluate the Efficacy and Safety of Subcutaneous Injections of BMN 165 Self-Administered by Adults With Phenylketonuria (PKU)

The BMN 165 clinical development program has been designed to demonstrate the safety and efficacy of BMN 165 in reducing blood Phe concentrations in adults with PKU.

Investigator:
Darius Adams, MD
165-302 | PHASE III

Sponsor:
BioMarin Pharmaceutical Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 70 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

INCLUSION CRITERIA
- Have completed a prior BMN 165 study (PAL-003 or 165-301) prior to screening
- Have had a stable BMN 165 dose regimen for at least 14 days prior to screening
- Are at least 18 y/o and no older than 70 y/o at screening
- Subjects who are < 18 y/o and are already enrolled into Study 165-301 under Amendment #1 (10JAN2014) may enroll into this study
- Has identified a person who is ≥ 18 y/o who has the neurocognitive and linguistic capacities to comprehend and complete the POMS-Observer rated scale
- Has identified a competent person(s) ≥ 18 y/o who can observe the subject during study drug administration at certain points in the study
- A home healthcare nurse may perform the study drug observations
- Are willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any research-related procedures; for minors, parent or guardian provides written consent and assent may be requested
- Are willing and able to comply with all study procedures
- For females of childbearing potential, a negative pregnancy test at screening and willing to have additional pregnancy tests during the study
- If sexually active, willing to use two acceptable methods of contraception during and for 4 weeks after the study
- Males post vasectomy for 2 years with no known pregnancies do not need to use any other forms of contraception during the study.
- Females who have been in menopause for at least 2 years, have had a tubal ligation at least 1 year prior to screening, or have had a total hysterectomy do not need to use any other forms of contraception during the study.
- Have received documented approval from a study dietitian confirming that the subject is capable of maintaining their diet
- Have neurocognitive and linguistic capacities to comprehend and answer investigator's prompts for the ADHD-RS Investigator rated instrument and to complete the POMS-Subject rated scale
- If applicable, maintained stable dose of medication for ADHD, depression, anxiety, or other psychiatric disorder ≥8 weeks prior to enrollment and willing to maintain stable dose throughout study unless a change is medically indicated
- General good health, as evidenced by physical examination, clinical laboratory evaluations, and ECG tests at screening

Exclusion Criteria

- Use of any investigational product (except BMN 165) or investigational medical device within 30 days prior to screening or requirement for any investigational agent prior to completion of all scheduled study assessments
- Use of any medication (except BMN 165) intended to treat PKU, including the use of large neutral amino acids, within 2 days prior to the administration of study drug
- Have known hypersensitivity to Dextran® or components of Dextran
- Use or planned use of any injectable drugs containing PEG (except for BMN 165), including medroxyprogesterone injection, within 3 months prior to screening and during study participation
- Current use of levodopa
- A positive test for HIV antibody, hepatitis B surface antigen, or hepatitis C antibody
- A history of organ transplantation or taking chronic immunosuppressive therapy
- A history of substance abuse in the past 12 months or current alcohol or drug abuse
- Current participation in the Kuvan registry study (PKUDOS). Patients may discontinue the PKUDOS registry trial to allow enrollment in this study
- Pregnant or breastfeeding at screening or planning to become pregnant (self or partner) or breastfeed at any time during the study
- Concurrent disease or condition that would interfere with study participation or safety.
- Major surgery planned during the study period
- Any condition that in the view of the investigator, places the subject at high risk of poor treatment compliance or terminating early from the study
- ALT concentration at least 2x the upper limit of normal
- Creatinine at least 1.5x the upper limit of normal

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Genetics
Completed

A Phase 3, Open-Label, Randomized, Multi-Center Study to Assess the Safety & Tolerability of an Induction, Titration, and Maintenance Dose Regimen of BMN 165 Self Administered by Adults w/ Phenylketonuria

The BMN 165 clinical development program has been designed to demonstrate the safety and efficacy of BMN 165 in reducing blood Phe concentrations in patients 18 to 70 years old with hyperphenylalaninemia due to PKU. Study BMN 165-301 is a Phase 3, open-label,...

Investigator:
Darius Adams, MD

randomized study designed to further characterize the safety of BMN 165 during two induction, titration, and maintenance dose regimens in adults with PKU who have not had previous exposure to BMN 165 (naive). Subjects will be randomized (1:1) to titrate up to one of two dose regimens. Other key features of this study are the dose regimens chosen for induction and titration; the study duration; self administration of study drug; and the chosen tertiary objectives.

165-301 | PHASE III

Sponsor:
BioMarin Pharmaceutical Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 70 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

INCLUSION CRITERIA

- A current diagnosis of PKU with the following:
Current blood Phe concentration >600 µmol/L at screening and Average blood Phe concentration of >600 µmol/L over the past 6 months (per available data)
- Have no previous exposure to BMN 165
- Are ≥18 and ≤70 years of age at the time of screening
Subjects who are < 18 years of age but are already enrolled into the study may continue to participate
- If taking Kuvan, have a treatment end date ≥14 days prior to Day 1 (ie, first dose of BMN 165)
- Are willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any research-related procedures
- Are willing and able to comply with all study procedures
- Has identified a person who is ≥ 18 years of age who has the neurocognitive and linguistic capacities to comprehend and complete the POMS-Observer-rated scale
- Has identified a competent person or persons who are ≥ 18 years of age who can observe the subject during study drug administration and for a minimum of 1 hour following administration until dose titration has completed and if needed upon return to dosing after an AE and per investigator determination.
- A home healthcare nurse may perform the study drug observations.
- For females of childbearing potential, must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during the study. (Females are considered not of childbearing potential if they have been in menopause for at least 2 years, have had a tubal ligation at least 1 year prior to screening, or have had a total hysterectomy.)
- If sexually active, must be willing to use 2 acceptable methods of contraception while participating in the study and 4 weeks after the study.
- Males post vasectomy 2 years with no known pregnancies for at least 2 years do not need to use any other forms of birth control during the study.
- Females who have been in menopause for at least 2 years, have had a tubal ligation at least 1 year prior to screening, or have had a total hysterectomy do not need to use any other forms of contraception during the study.
- Have received documented approval from a study dietician confirming that the subject is capable of maintaining their diet in accordance with dietary information presented in the protocol.
- Have neurocognitive and linguistic capacities to comprehend and answer investigator's prompts for the ADHD RS- Investigator rated instrument and to complete the POMS-Subject rated scale.
- If applicable, maintained stable dose of medication for attention deficit hyperactivity disorder (ADHD), depression, anxiety, or other psychiatric disorder for ≥8 weeks prior to enrollment and willing to maintain stable - - Are in generally good health, as evidenced by physical examination, clinical laboratory evaluations and ECG tests performed at screening

EXCLUSION CRITERIA
- Use of any investigational product or investigational medical device within 30 days prior to screening or requirement for any investigational agent prior to completion of all scheduled study assessments.
- Use of any medication that is intended to treat PKU (except Kuvan), including the use of large neutral amino acids, within 2 days prior to administration of study drug Day 1 (first dose of BMN 165). Note: Kuvan treatment must be stopped ≥14 days before Day 1
- Use or planned use of any injectable drugs containing PEG (other than BMN 165), including medroxyprogesterone injection, within 3 months prior to screening and during study participation
- Known hypersensitivity to any components of BMN 165
- Current use of levodopa
- A positive test for HIV antibody, hepatitis B surface antigen, or hepatitis C antibody
- A history of organ transplantation or on chronic immunosuppressive therapy
- A history of substance abuse (as defined by the Diagnostic and Statistical Manual of Mental Disorders [DSM IV]) in the past 12 months or current alcohol or drug abuse
- Current participation in the Kuvan registry study (PKU Demographics, Outcomes and Safety [PKUDOS]). Patients may discontinue the PKUDOS registry trial to allow enrollment in this study
- Pregnant or breastfeeding at screening or planning to become pregnant (self or partner) or breastfeed at any time during the study
- Concurrent disease or condition that would interfere with study participation or safety (eg, history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurological, oncologic, or psychiatric disease)
- Major surgery planned during the study period
- Any condition that, in the view of the investigator, places the subject at high risk of poor treatment compliance or terminating early from the study
- Alanine aminotransferase (ALT) concentration >2 times the upper limit of normal
- Creatinine >1.5 times the upper limit of normal.

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Genetics
Open to Enrollment

A Prospective Non-interventional Study in Subjects With Late Onset Pompe Disease Who Are Currently Being Treated With Enzyme Replacement Therapy

The purpose of the study is to evaluate changes in key clinical outcome measures (eg, motor, respiratory, fatigue) in late-onset Pompe disease (LOPD) subjects receiving standard-of-care enzyme replacement therapy (ERT). Additionally, information gained may...

Investigator:
Darius Adams, MD

be used in the design and conduct of future studies in LOPD subjects.

POM-003

Sponsor:
Amicus Therapeutics, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 7 Years to 75 Years (Child, Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population

LOPD patients between the age of 7 to 75 years, male and female.

Inclusion Criteria:
1. Subject has a diagnosis of Pompe disease based on documented deficiency of GAA activity and a documented GAA mutation.
2. Male and female subjects between 7 years and 75 years, inclusive.
3. Subject must be currently receiving standard-of-care ERT (alglucosidase alfa) at a dose of 20 mg/kg dose every other week.
4. Subject must have been on ERT for the preceding 2 years or more.
5. Subject must have an upright FVC that is within 33 to 80% of predicted normal, based on the higher of the screening or baseline value.
6. Subject is able to walk at least 200 m in the 6MWT.

Exclusion Criteria:
1. Subject has received any investigational therapy or pharmacological treatment for Pompe disease, other than alglucosidase alfa within 30 days prior to the Baseline Visit or is anticipated to do so during the course of the study
2. Subject is on any of the following prohibited medications within 30 days of baseline:
◦miglitol (eg, Glyset)
◦miglustat (eg, Zavesca)
◦acarbose (eg, Precose, Glucobay)
◦voglibose (eg, Volix, Vocarb, Volibo)
3. Subject requires use of invasive or non-invasive ventilatory support for > 6 hours a day while awake.
4. Subject has a medical or any other extenuating condition or circumstance that may, in the opinion of the investigator, pose an undue safety risk to the subject or compromise his/her ability to comply with protocol requirements.
5. Subject is pregnant.

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Genetics
Open to Enrollment

CAscade SCreening for Awareness and Detection of Familial Hypercholesterolemia

The CASCADE-FH Registry is a national, multi-center initiative that will track the therapy, clinical outcomes, and patient-reported outcomes over time. The registry represents a collaboration between The Familial Hypercholesterolemia Foundation, the Duke Clinical...

Investigator:
Robert Fishberg, MD

Research Institute, lipid specialists, cardiologists, primary care providers, quality improvement personnel, and patients, all aiming to increase FH awareness, promote optimal disease management, and improve FH outcomes.

CASCADE

Sponsor:
Duke Clinical Research Institute

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population:
Patients diagnosed Familial hypercholesterolemia (FH).

Inclusion Criteria:

Online Patient Enrollment Inclusion Criteria:
• Patients with existing clinical diagnosis of FH;
• Patients with genetic mutation of FH;
• Patients with an initial (pretreatment) LDL level >190 mg/dL or total cholesterol >300 mg/dL;
• Patients currently taking a lipid-lowering medication and have an LDL >124 mg/dL or total cholesterol >195 mg/dL.

Clinic Patient Enrollment Inclusion Criteria:
• Patients with existing clinical diagnosis of FH using one of the three clinical diagnostic (US MedPed Program Criteria, Simon Broome Register Criteria with diagnosis of "Probable", Dutch Lipid Clinic Network Diagnostic Criteria with diagnosis of "Probable")tools for FH; or
• Patients with genetic mutation of FH

Exclusion Criteria:
• Patients will be excluded from participation in the registry when a known medical condition other than FH that is thought to contribute to hyperlipidemia (i.e., untreated hypothyroidism, nephrotic syndrome, cholestasis hypopituitarism).

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Genetics
Open to Enrollment

Fabry Disease Registry

The Fabry Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Fabry disease, irrespective of treatment status. No experimental intervention is involved; patients in...

Investigator:
Darius Adams, MD

the Registry undergo clinical assessments and receive care as determined by the patient's treating physician.

Fabry Registry | PHASE NA

Sponsor:
Genzyme Corporation

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population:
All patients with a confirmed diagnosis of Fabry disease are eligible for inclusion in the Registry.

Inclusion Criteria All patients with a confirmed diagnosis of Fabry disease who have signed the informed consent and patient authorization form(s) are eligible for inclusion. Confirmed diagnosis is defined as a documented deficiency in plasma or leukocyte αGAL (alpha-galactosidase) enzyme activity and/or mutation(s) in the gene coding for αGAL.

Exclusion Criteria There are no exclusion criteria in this Registry. Patients are allowed to participate in other clinical studies and may be receiving different therapies to treat their disease; however, enrollment in other clinical studies should be noted on the Registry case report forms (CRFs).

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Genetics
Open to Enrollment

International Collaborative Gaucher Group (ICGG) Gaucher Registry

The ICGG Gaucher Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Gaucher disease, irrespective of treatment status. No experimental intervention is involved; patients...

Investigator:
Darius Adams, MD

in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician.

Gaucher Registry | PHASE NA

Sponsor:
Genzyme Corporation

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Inclusion Criteria:
• All patients with a confirmed diagnosis of Gaucher disease are eligible for inclusion in the Registry. Confirmed diagnosis is defined as a documented β-glucocerebrosidase deficiency and/or mutation in the β-glucocerebrosidase gene.
• For all patients, appropriate patient authorization will be obtained.

Exclusion Criteria:
• No exclusion criteria for participation in the ICGG Gaucher Registry.NOTE: Registry participation does not exclude participation in other clinical studies.

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Genetics
Open to Enrollment

Mucopolysaccharidosis I (MPS I) Registry

The Mucopolysaccharidosis I (MPS I) Registry is an ongoing, observational database that tracks the outcomes of patients with MPS I. The data collected by the MPS I Registry will provide information to better characterize the natural history and progression...

Investigator:
Darius Adams, MD

of MPS I as well as the clinical responses of patients receiving enzyme replacement therapy, such as Aldurazyme (Recombinant Human Alpha-L-Iduronidase), or other treatment modalities.

MPS I Registry | PHASE NA

Sponsor:
Genzyme Corporation

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample

Study Population:
All Patients with MPS I

Inclusion Criteria:
• All patients with a confirmed diagnosis of MPS I are eligible for inclusion. Confirmed diagnosis is defined as: A. documented biochemical evidence of a deficiency in alpha (a)-L-iduronidase enzyme activity and/or B. mutation(s) in the gene coding for a-L-iduronidase, or measurable clinical signs and symptoms of MPS I
• For all patients there should be a completed patient authorization form

Exclusion Criteria:
• No exclusion criteria for participation in the MPS I Registry. NOTE: Registry participation does not exclude participation in other clinical studies.

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Genetics
Open to Enrollment

PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry

The PKUDOS program is a voluntary, multicenter, strictly observational program for patients with PKU who have either received Kuvan therapy, or currently receive Kuvan, or intends to begin receiving Kuvan therapy within 90 days of entering the registry.

Investigator:
Darius Adams, MD
PKUDOS | PHASE NA

Sponsor:
BioMarin Pharmaceutical Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: Child, Adult, Senior
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population: Diagnosis of Phenylketonuria with hyperphenylalaninemia

PKUDOS Registry

Inclusion Criteria:
• Patient has confirmed diagnosis of PKU with hyperphenylalaninemia documented by a Phenylalanine level of greater than or equal to 360 umol/L (6 mg/dL)
• Patient has previously received Kuvan
• Patient is currently receiving Kuvan
• Patient intends to receive Kuvan therapy within 90 days of enrollment into the registry
• The Patient is being followed at a PKUDOS participating center
• Willing and able to provide written authorization or, if under the age of 18 years, provide written assent (if required) and written patient authorization by a parent or legal guardian
• Willing to provide personal health information

Exclusion Criteria:
• Patients are not eligible to participate in PKUDOS if they are participating in a BioMarin-sponsored clinical study of Kuvan
• Patients not previously treated with Kuvan and patients that are unwilling to begin Kuvan therapy within 90 days of entry into the registry

PKU MOMS Subregistry

Inclusion Criteria:
• Willing to enroll in (or are already enrolled in) PKUDOS
• Agree to follow the standard of care for pregnant women with PKU in the United States (NIH, 200, NIH Consensus Statement)
• Agree to be followed by a hospital or PKU clinic offering the standard of care for maternal PKU
• Are within 10 weeks of their last menstrual period

Exclusion Criteria:
• Patients who have not adhered to the standard of care for pregnant women with PKU in the United States are not eligible to participate in PKU MOMS

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Genetics
Open to Enrollment

Pompe Disease Registry

The Pompe Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Pompe disease, irrespective of treatment status. No experimental intervention is involved; patients in...

Investigator:
Darius Adams, MD

the Registry undergo clinical assessments and receive care as determined by the patient's treating physician.

Pompe Registry | PHASE NA

Sponsor:
Genzyme Corporation

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population:
Patients diagnosed with Pompe disease

Inclusion Criteria:
• Patient must have a confirmed diagnosis of Pompe disease, documented by GAA(Glucosidase Alpha Acid) enzyme deficiency or GAA gene mutation

Exclusion Criteria:
• There are no exclusion criteria

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Growth Hormone Deficiency
Open to Enrollment

A Phase 3, Open-label, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin - Therapy in Pre-pubertal Children With Growth Hormone Deficiency

This will be an open-label, randomized, multicenter, efficacy and safety study of weekly MOD-4023 compared to daily Genotropin therapy in pre-pubertal children with growth hormone deficiency.

Investigator:
Barbara Cerame, MD
CP-4-006 | PHASE III

Sponsor:
OPKO Biologics Ltd.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 3 Years to 11 Years (Child)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Pre-pubertal children aged ≥3 years , and not yet 11 years for girls or not yet 12 years with either isolated GHD, or GH insufficiency as part of multiple pituitary hormone deficiency.
2. Confirmed diagnosis of GHD by two different GH provocation tests defined as a peak plasma GH level of ≤10 ng/mL,
3. Bone age (BA) is not older than chronological age and should be less than 10 for girls and less than 11 for boys.
4. Without prior exposure to any rhGH therapy (naïve patients).
5. Impaired height velocity defined as:
o Annualized height velocity (HV) below the 25th percentile for CA (HV < -0.7 SDS) and gender according
6. BMI must be within ±2 SDS of mean BMI for the chronological age and sex.
7. Baseline IGF-I level of at least 1 SD below the mean IGF-I level standardized for age and sex (IGF-I SDS ≤-1)
8. Normal calculated GFR
9. Normal 46XX karyotype for girls.

Exclusion Criteria:
1. Children with prior history of leukemia, lymphoma, sarcoma or any other forms of cancer.
2. History of radiation therapy or chemotherapy
3. Malnourished children defined as BMI < -2 SDS for age and sex
4. Children with psychosocial dwarfism
5. Children born small for gestational age (SGA - birth weight and/or birth length <-2 SDS for gestational age)
6. Presence of anti-hGH antibodies at screening
7. Chromosomal abnormalities including Turner's syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, SHOX mutations/deletions and skeletal dysplasias.
8. Concomitant administration of other treatments that may have an effect on growth
9. Major medical conditions and/or presence of contraindication to r-hGH treatment.
10. Closed epiphyses
11. Known or suspected HIV-positive patient, or patient with advanced diseases such as AIDS or tuberculosis.
12. Drug, substance, or alcohol abuse.
13. Known hypersensitivity to the components of study medication.
14. Other causes of short stature such as celiac disease, uncontrolled primary hypothyroidism and rickets.

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Growth Hormone Deficiency
Open to Enrollment

A Trial Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency naïve Pre-pubertal Children With Growth Hormone Deficiency

This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with...

Investigator:
Lawrence Silverman, MD

growth hormone deficiency.

NN8640-4172 | PHASE II

Sponsor:
Novo Nordisk Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 2 Years to 10 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Boys: Tanner stage 1 for pubic hair and testis volume below 4 ml , age at least 2 years and 26 weeks and below or equal to 10.0 years at screening
• Girls: Tanner stage 1 for breast development (no palpable glandular breast tissue) and pubic hair, age at least 2 years and 26 weeks and below or equal to 9.0 years at screening
• Confirmed diagnosis of GHD (growth hormone deficiency) within 12 months prior to screening as determined by two different GH (growth hormone) stimulation tests, defined as a peak GH level of below or equal to 7.0 ng/ml. For children with three or more pituitary hormone deficiencies only one GH stimulation test is needed
• No prior exposure to GH therapy and/or IGF-I (insulin-like growth factor I) treatment
• Height of at least 2.0 standard deviations below the mean height for chronological age (CA) and gender according to the standards of Centers for Disease Control and Prevention 2-20 years: Girls/Boys stature-for-age and weight-for-age percentiles CDC at screening
• Annualized height velocity (HV) below the 25th percentile for CA (chronological age) and gender or below -0.7 SD (standard deviation) score for CA and sex, according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months

Exclusion Criteria:
• Any clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing measurements: Chromosomal aneuploidy and significant gene mutations causing medical "syndromes" with short stature, including but not limited to Turner syndrome, Laron syndrome, Noonan syndrome, or absence of GH receptors. Congenital abnormalities (causing skeletal abnormalities), including but not limited to Russell-Silver Syndrome, skeletal dysplasias. Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants
• Children born small for gestational age (SGA - birth weight and/or birth length below-2 SD for gestational age)
• Concomitant administration of other treatments that may have an effect on growth, including but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder (ADHD)
• Prior history or presence of malignancy and/or intracranial tumour

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Growth Hormone Deficiency
Completed

An Open-Label, Long-Term Extension Study of the Safety and Efficacy of A Long-acting Human Growth Hormone (VRS-317) in Children with Growth Hormone Deficiency

Protocol 13VR3 is designed as an open-label extension study assessing long-term VRS-317 administration. It is open to subjects completing a Versartis Phase 2 or 3 study in children with growth hormone deficiency. Patients will be monitored for safety throughout...

Investigator:
Lawrence Silverman, MD

their participation in the study. Safety will be monitored by physical examination, inspection of injection sites, vital signs and clinical laboratory determinations. Adverse events (AEs) and concomitant medications will be captured. AEs will be coded using CTCAE.

13VR3 | PHASE II/III

Sponsor:
Versartis, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 3 years to 12 Years
Genders Eligible for Study: Both
Accepts Health Volunteers: No

Inclusion Criteria:
• Completion of a Versartis Phase 2 or Phase 3 clinical study in pediatric patients with GHD
• Willing and able to comply with all study procedures

Exclusion Criteria:
• Withdrawal from a Versartis clinical study in pediatric patients with GHD
• Lack of compliance in a Versartis clinical study in pediatric patients with GHD
• Use of prohibited medications that may alter responses to the test product
• Presence of certain medical condition conditions if condition or treatment of condition may alter response to test product

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Growth Hormone Deficiency
Open to Enrollment

fliGHt: A Multicenter, Phase 3, Open-Label, 26-Week Trial Investigating the Safety, Tolerability and Efficacy of TransCon hGH Administered Once Weekly in Children With GHD

A 26 week trial of TransCon hGH, a long-acting growth hormone product, administered once-a-week. Approximately 150 children (males and females) with growth hormone deficiency (GHD) will be included. All study participants will receive TransCon hGH. This is...

Investigator:
Lawrence Silverman, MD

a global trial that will be conducted in, but not limited to, the United States, Canada, Australia, and New Zealand.

FLIGHT | PHASE III

Sponsor:
Ascendis Pharma Endocrinology Division A/S

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 6 Months to 17 Years (Child)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Investigator-determined GHD diagnosis prior to the historical initiation of daily hGH therapy.
2. 6 months to 17 years old, inclusive, at Visit 1
1. If 3 to 17 years old, are taking daily hGH at a dose of ≥ 0.20 mg hGH/kg/week for at least 13 weeks but no more than 130 weeks prior to Visit 1
2. If ≥ 6 months but < 3 years old, are either hGH treatment-naïve or are taking daily hGH at a dose of ≥ 0.20mg hGH/kg/week for no more than 130 weeks prior to Visit 1
3. Tanner stage < 5 at Visit 1
4. Open epiphyses (bone age ≤14.0 years for females or ≤16.0 years for males)
5. Written, signed, informed consent of the parent or legal guardian of the subject and written assent of the subject as required by the IRB/HREC/IEC

Exclusion Criteria:
1. Weight of < 5.5 kg or > 80 kg at Visit 1
2. Females of child-bearing potential
3. History of malignant disease
4. Any clinically significant abnormality likely to affect growth or the ability to evaluate growth (eg, chronic diseases or conditions such as renal insufficiency, spinal cord irradiation, hypothyroidism, active celiac disease, malnutrition or psychosocial dwarfism)
5. Poorly-controlled diabetes mellitus (HbA1c >8.0%) or diabetic complications
6. Known neutralizing antibodies against hGH
7. Major medical conditions, unless approved by Medical Monitor
8. Pregnancy
9. Presence of contraindications to hGH treatment
10. Likely to be non-compliant with respect to trial conduct (in regards to the subject and/or the parent/legal guardian/caregiver)
11. Participation in any other trial of an investigational agent within 30 days prior to Visit 1
12. Prior exposure to investigational hGH

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Head & Neck Cancer
Open to Enrollment

A Phase 1b/2, Open-Label, Multicentre Study Assessing the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of MEDI4736 in Combination With AZD9150 or AZD5069 in Patients With Advanced Solid Malignancies and Subsequently Comparing AZD9150 and AZD5069 Both as Monotherapy and in Combination With MEDI4736 as Second Line Treatment in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

This multicentre, open-label, Phase 1b/2 study is designed as a 2 part study consisting of a dose-escalation Part A and a dose-expansion Part B.

Investigator:
Eric Whitman, MD
D5660C00004 | PHASE I/II

Sponsor:
AstraZeneca

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 130 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Key Inclusion Criteria:
• Male and female patients must be at least 18 years of age.
• Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.
• Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases). Indicator lesions must not have been previously treated with surgery, radiation therapy, or radiofrequency ablation unless there is documented progression after therapy.
• Has undergone ≤3 previous regimens of cytoreductive therapies including, but not limited to, platinum-based compounds, taxanes, or 5-fluorouracil.
• Adequate organ and marrow function
• Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol
• Additional inclusion for part A: Has a histological confirmation of a solid malignancy (other than HCC) that is refractory to standard therapy or for which no standard of care regimen currently exists.
• Additional inclusion for Part B:Has histologically and/or cytologically confirmed SCCHN that is RM and not amendable to curative therapy by surgery or radiation. Squamous cell carcinoma of the head and neck originating from the following sites is eligible: oral cavity, oropharynx, larynx, or hypopharynx. Has at least 1 SCCHN tumour lesion (TL) amenable to biopsy and must have failed, refused, or has been found to be ineligible for least 1 prior platinum-based chemotherapy for RM-SCCHN Additional inclusion criteria for Arms B1 & B2:must have had prior exposure to anti PDL-1 antibody

Key Exclusion Criteria:
• Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment. - Presently has a second malignancy other than SCCHN, or history of treatment for invasive cancer other than SCCHN in the past 3 years. Exceptions are
• Previously treated in-situ carcinoma (ie, noninvasive)
• Cervical carcinoma stage 1B or less
• Noninvasive basal cell and squamous cell skin carcinoma Radically treated prostate cancer (prostatectomy or radiotherapy) with normal prostate-specific antigen, and not requiring ongoing antiandrogen hormonal therapy
• Patients must have completed any previous cancer-related treatments before enrolment. Any concurrent chemotherapy, radiotherapy, immunotherapy, or biologic, or hormonal therapy for cancer excludes the patient (concurrent use of hormones for noncancer-related conditions [eg, insulin for diabetes and hormone replacement therapy] is acceptable),
• Experiencing CTCAE grade >1 events, experienced immune-related grade ≥3AEs with prior immunotherapy
• Has active or prior autoimmune disease within the past 2 years
• Has active or prior inflammatory bowel disease or primary immunodeficiency
• Undergone an organ transplant that requires use of immunosuppressive treatment
• Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG
• Uncontrolled comorbid conditions
• Received a live attenuated vaccine within 28 days of first study dose, unable to take oral medications
• History of allergic reactions to study compounds or excepients Additional exclusion criteria Part A: Patients with clinically active brain metastases and prior exposure to AZD9150, AZD5069, MEDI4736, or any other anti PD (L)1 antibody.
Additional exclusion criteria Part B: Patients with brain metastases (known or suspected) Additional exclusion criteria Part B: treatment arms B3, B4, B5, and B6: prior exposure to AZD9150, AZD5069, MEDI4736, or any other anti PD (L)1 antibody.

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Head & Neck Cancer
Open to Enrollment

A Phase 1b/2a, Multi-Center Open-Label Study to Evaluate the Safety and Efficacy of Combination Treatment With MEDI0457 (INO-3112) and Durvalumab (MEDI4736) in Patients With Recurrent/Metastatic HPV Associated Head and Neck Squamous Cancer

This is a Phase 1b/2a, open-label, multi-center study to evaluate the safety and tolerability, anti-tumor activity, and immunogenicity of MEDI0457 (also known as INO 3112) a HPV DNA vaccine in combination with durvalumab (also known as MEDI4736) which is a...

Investigator:
Missak Haigentz, MD

human monoclonal antibody directed against PD-L1, which blocks the interaction of PD-L1 with PD-1 and CD80.

D8860C00005 | PHASE I/II

Sponsor:
MedImmune, LLC

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 99 Years (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Male and female subjects 18 years and older
2. Histologically or cytologically confirmed diagnosis of HNSCC associated with HPV by a p16 immunohistochemistry (IHC) assay or HPV-16 or HPV-18 positive by nucleic acid testing.
3. Recurrent or metastatic disease that has been treated with at least one platinum-containing regimen and lacking a curative treatment option.
4. Patients who are platinum ineligible may be enrolled if they have received and failed an approved treatment and lack a treatment option with curative potential.

Exclusion criteria:
1. Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment Active or prior documented autoimmune disease with some exceptions.
2. Current or prior use of immunosuppressive medication within 14 days prior to first study dose, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at doses not to exceed 10 mg/day of prednisone or equivalent. Steroids as premedication for hypersensitivity reactions due to radiographic contrast agents are allowed.
3. No prior exposure to immune-mediated therapy defined as prior exposure to T-cell and natural killer cell directed therapy (e.g., anti-PD-1, anti-PD-L1, anti-CD137, and anti-CTLA4, etc).

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Head & Neck Cancer
Open to Enrollment

A Phase 2 Study to Evaluate the Safety and Efficacy of Cell Transfer Therapy Using Autologous Tumor Infiltrating Lymphocytes (LN-145) Followed by IL-2 in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Prospective, multicenter, single-arm, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative...

Investigator:
Missak Haigentz, MD

regimen for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

C-145-03 | PHASE II

Sponsor:
Iovance Biotherapeutics, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Must be greater than 18 years of age at the time of consent.
• Must have persistent, recurrent or metastatic HNSCC; histologic documentation of the primary tumor is required via the pathology report.
• Must have had at least 1 prior systemic chemotherapeutic regimen for management of persistent, recurrent or metastatic HNSCC. Patients must not have any curative therapy options, or be intolerant of, or decline standard of care therapy for persistent, recurrent or metastatic disease.
• Any prior therapy directed at the malignant tumor, including radiation therapy, chemotherapy, biologic/targeted agents and immunologic agents must be discontinued at least 21 days prior to tumor resection for preparing TIL therapy.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patients must be seronegative for the HIV antibody, hepatitis B antigen, and hepatitis C antibody or antigen.
• Female patients of childbearing potential must be willing to practice an approved method of birth control starting at the time of informed consent and for 1 year after the completion of the lymphodepletion regimen.

Exclusion Criteria:
• Patients who are on a systemic steroid therapy (greater than 10 mg of prednisone or equivalent) within 28 days prior to Visit 2.
• Patients who currently have prior therapy-related toxicities greater than Grade 1 according to Common Toxicity Criteria for Adverse Events (CTCAE) v4.03; (see Appendix Section 16.4), except for alopecia or vitiligo prior to enrollment.
• Patients who have had immunotherapy-attributable AE: which led to discontinuation, or have had an ophthalmologic or neurologic AE of any grade, or actively receiving any immunosuppressive agents for the treatment of toxicity related to prior immunotherapy.
• Patients with documented Grade 2 or greater diarrhea or colitis as a result of previous immunotherapy within six months from screening.
• History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or IL-2.
• Patients with active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system.
• Have any form of primary immunodeficiency, such as severe combined immunodeficiency disease or acquired immune deficiency syndrome (AIDS).
• Diagnosis of end-stage renal disorder requiring hemodialysis.
• Patients who have a left ventricular ejection fraction (LVEF) < 45%.
• Patients who have a FEV1 (forced expiratory volume in one second) of less than or equal to 60 % of normal.

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Head & Neck Cancer
Open to Enrollment

A Phase II Study of Enzalutamide (NSC# 766085) for Patients With Androgen Receptor Positive Salivary Cancers

This study will test any good and bad effects of the study drug called enzalutamide. Enzalutamide could shrink the cancer but it could also cause side effects. Researchers hope to learn if the study drug will shrink the cancer by at least 30% compared to its...

Investigator:
Missak Haigentz, MD

present size, in at least 1 out of 5 patients. Enzalutamide is not FDA approved to treat salivary gland cancer, but it has already been FDA-approved to treat other cancers.

A091404 | PHASE II

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Criteria:
1. Documentation of Disease - Histologic Documentation: Histologically proven diagnosis of salivary cancer by central pathology review. Receptor status: AR expression detected by immunohistochemistry by central review.
2. Disease status - Measurable disease as defined in the protocol. Locally advanced/unresectable (as determined by local surgeon) OR metastatic disease.
3. Prior Treatment
◦ Any number of prior lines of therapy
◦ No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation ≤ 28 days before study registration. No treatment with nitrosourea or mitomycin ≤ 42 days before study registration
◦ No prior therapy with enzalutamide (previous chemotherapy and/or other AR-targeted approaches is allowed).
4. Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. A female of childbearing potent is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (ie, has had menses at any time in the preceding 12 consecutive months). For women of childbearing potential only, a negative pregnancy test done ≤ 5 days prior to registration is required.
5. Age ≥ 18 years
6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
7. No History of the following:
◦ prior brain metastases
◦ leptomeningeal disease
◦ seizures
◦ class 3 or 4 congestive heart failure
◦ uncontrolled hypertension (systolic BP > 170 mmHg or diastolic BP > 105 mmHg)
◦ major surgery ≤ 4 weeks of registration
8. Required Initial Laboratory Values:
◦ Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
◦ Platelet Count ≥ 100,000/mm3
◦ Creatinine ≤ 1.5 x ULN Upper Limit of Normal (ULN) OR
◦ Calculated Creatinine Clearance ≥ 30 mL/min
◦ Total Bilirubin ≤ 1.5 x ULN
◦ AST/ALT ≤ 3.0 x ULN
9. Concomitant medications- Chronic concomitant treatment with strong CYP2C8 inhibitors is not allowed. Patients must discontinue the drug ≥ 14 days prior to registration. Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug ≥ 14 days prior to registration.

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Head & Neck Cancer
Open to Enrollment

A Phase III Randomized, Open-label, Multi-center, Global Study of MEDI4736 in Combination With Tremelimumab Versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer (SCCHN) Patients

This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior...

Investigator:
Eric Whitman, MD

systemic chemotherapy for recurrent or metastatic disease.

KESTREL | PHASE III

Sponsor:
AstraZeneca

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Age ≥18 years at the time of screening
2. Documented evidence of SCCHN (oral cavity, oropharynx, hypopharynx, or larynx).
3. A fresh tumor biopsy for the purpose of screening or an available archival tumor sample. Tumor lesions used for fresh biopsies should not be the same lesions used as RECIST target lesions, unless there are no other lesions suitable for biopsy.
4. No prior systemic chemotherapy for recurrent or metastatic disease
5. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
6. No prior exposure to immune-mediated therapy,

Exclusion Criteria:
1. Received any systemic therapy for recurrent or metastatic SCCHN
2. Tumor progression or recurrence within 6 months of last dose of platinum therapy in the primary treatment setting
3. Receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days prior to first dose of study treatment
4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitis

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Heart Disease
Open to Enrollment

A Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS): The Dal-GenE Trial

A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are...

Investigator:
Robert Fishberg, MD

performed. Subject enrollment may begin in the hospital and will continue following release from the hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (4-12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

DAL-301 | PHASE III

Sponsor:
Dalcor Pharma UK LTD

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 45 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Subjects with the appropriate genetic background and recently hospitalized for ACS (between 4 and 12 weeks following the index event), will be enrolled in this trial.
• AA genotype at variant gene as determined by Genotype Assay testing, conducted at a designated investigational testing site (ITS)
• Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for at least 1 week prior to randomization
• Prior to randomization, subject must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment to a target level of LDL-C <100 mg/dl (<2.6 mmol/L).

Exclusion Criteria:
• Females who are pregnant (negative pregnancy test required for all women of child-bearing potential at Visit 2, Day 0) or breast-feeding
• Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not simultaneously using two effective contraceptive methods, and one of which being a barrier method (diaphragm, cervical cap, male condom, etc.)
• New York Heart Association (NYHA) Class III or IV heart failure
• Last known hemoglobin <10 g/dL
• Index ACS event presumed due to uncontrolled hypertension

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Heart Disease
Open to Enrollment

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of SAR236553/REGN727 on the Occurence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome

To compare the effect of alirocumab with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization)...

Investigator:
Robert Fishberg, MD

in patients who have experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and are treated with evidence-based medical and dietary management of dyslipidemia.

EFC11570

Sponsor:
Sanofi US Services Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 40 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion criteria :

Recently (< 52 weeks) hospitalized for ACS.

Exclusion criteria:
•Age < 40 years.
•ACS event occurring more than 52 weeks prior to randomization visit.
•LDL-C likely to be <70 mg/dL (<1.81 mmo/L) with evidence-based medical and dietary management of dyslipidemia.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Heart Disease
Open to Enrollment

Coronary InterventionS in HIgh-Risk PatiEnts Using a Novel Percutaneous Left Ventricular Support Device (SHIELD II)

The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and...

Investigator:
Barry Cohen, MD

depressed left ventricular ejection fraction.

Shield II

Sponsor:
Thoratec Corporation

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 100 Years (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• At least 18 years of age.
• Patient is undergoing elective or urgent high risk PCI procedure and is hemodynamically stable
• Patient is indicated for a revascularization of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft
• A Heart Team that includes a Cardiac Surgeon who has seen the patient, has determined with concurrence of the Cardiac Surgeon member, that high risk PCI is the appropriate therapeutic option
• The presence of complex coronary artery disease (CAD) makes hemodynamic instability resulting from repeat episodes of reversible myocardial ischemia during PCI likely. Complex CAD is defined as:
◦ an ejection fraction of ≤35% AND at least one of the following:
◾intervention of the last patent coronary conduit, OR
◾intervention of an unprotected left main artery OR
◦ an ejection fraction of ≤35% AND intervention on patient presenting with triple vessel disease defined as at least one significant stenosis (at least 50% diameter stenosis on visual assessment) in all three major epicardial territories
• Written, signed, and dated informed consent

Exclusion Criteria:
• Emergency PCI
• Myocardial infarction at baseline
• Cardiac arrest within 24 hours of procedure requiring CPR or defibrillation
• Hemodynamic support with the HeartMate PHP post-PCI is anticipated
• Cardiogenic shock (systolic blood pressure (SBP)) <90 mmHg for >1 hour with either cool clammy skin OR oliguria OR altered sensorium and cardiac index <2.2 L/min/m2)
• Mural thrombus in the left ventricle
• History of aortic valve replacement
• Documented presence of aortic stenosis (orifice area of 1.5cm2 or less)
• Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher)
• Severe peripheral vascular disease
• Abnormalities of the aorta that would preclude surgery, including aneurysms and significant tortuosity or calcifications
• Patient is on hemodialysis
• Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x upper limit of normal (ULN) or INR (Internationalized Normalized Ratio) ≥2 or lactate dehydrogenase (LDH) > 2.5x ULN.
• Uncorrectable abnormal coagulation parameters (platelet count ≤75000/mm3 or INR ≥2.0 or fibrinogen ≤1.5 g/l)
• Active systemic infection requiring treatment with antibiotics
• Stroke or transient ischemic attack (TIA) within 6 month of procedure
• Any allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or antiplatelet therapy drugs that cannot be adequately premedicated
• Patient is pregnant
• Participation in another clinical study of an investigational drug or device that has not met its primary endpoint

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Heart Disease
Open to Enrollment

Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

The study is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and development efforts of the Edwards...

Investigator:
John Brown, MD

FORMA Tricuspid Transcatheter Repair System.

FORMA

Sponsor:
Edwards Lifesciences LLC

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Clinically significant, symptomatic (NYHA Functional Class II or greater) functional or secondary, tricuspid regurgitation (per applicable guidelines) requiring tricuspid valve repair or replacement as assessed by the Heart Team
2. NYHA Functional Class II or greater or signs of persistent right heart failure despite optimal medical therapy
3. Determined by the 'HEART Team' (a minimum of one Cardiologist, and one Cardiac Surgeon) to be at high surgical risk for tricuspid valve repair or replacement and the benefit-risk analysis supports utilization of the investigational device

Exclusion Criteria:
1. See Protocol

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Heart Disease
Open to Enrollment

Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts: The ECLIPSE Trial

This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES).

Investigator:
Jordan Safirstein, MD
ECLIPSE

Sponsor:
Cardiovascular Systems, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

General Inclusion Criteria:
1. Subject is 18 years of age or older.
2. Subject presents with:
1. stable ischemic heart disease or
2. non-ST elevation acute coronary syndrome, or
3. recent (>48 hours) STEMI
3. Subject has signed the Institutional Review Board (IRB) approved ECLIPSE trial Informed Consent Form (ICF) prior to any trial related procedures, per site requirements.
4. Subject agrees to comply with all follow-up visits and trial procedures.

General Exclusion Criteria:
1. Subject has the inability to understand the trial requirements or has a history of non-adherence with medical advice.
2. Subject has a history of any cognitive or mental health status that would interfere with trial participation.
3. Subject is participating in or has plans to participate in any other investigational drug or device trial that has not reached its primary endpoint.
4. Subject is a female who is pregnant and/or breastfeeding or planning to become pregnant within 1-year.
5. Subject is receiving or scheduled to receive chemotherapy within thirty (30) days prior or any time after the index procedure.
6. Subject has a life expectancy of ≤ twelve (12) months.
7. Subject has undergone any prior PCI in the target vessel or its branches within the prior 12 months.
8. Subject has undergone an unsuccessful or complicated PCI procedure within 30 days prior to randomization, including during the index procedure.
9. Any cardiovascular intervention is planned within 1 year post index procedure aside from a potential planned staged PCI as part of the randomized treatment strategy (see staged and multilesion / multivessel procedure section).
10. Subject has experienced an ST-Segment Elevation Myocardial Infarction (STEMI) within 48 hours.
11. Evidence of heart failure by at least one of the following (note - Left Ventricular Ejection Fraction [LVEF] is not required by protocol):
1. Most recent LVEF ≤25%, or
2. Heart failure (NYHA class ≥3 or Killip class ≥2)
12. Planned use of bare metal stent (BMS), bioresorbable scaffold (BRS), non-stent treatment only of the randomized lesion(s).
13. Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated.
14. Subject has a relative or absolute contraindication to aspirin or all P2Y12 inhibitor agents, or will be unable to take both aspirin and a P2Y12 inhibitor for at least 6 months after PCI (e.g., due to a planned surgical procedure).
15. Subject has a history of a stroke or transient ischemic attack (TIA) within six (6) months, or any permanent neurologic deficit.
16. Subject has a history of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary.
17. Subject is being treated with or will begin treatment with chronic oral anticoagulation (warfarin or NOAC).
18. Subject has evidence of active infection on the day of the index procedure.
19. Subject is not an acceptable candidate for emergent coronary artery bypass graft (CABG).
20. Subject with known allergy to atherectomy lubricant components including soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.

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Heart Disease
Open to Enrollment

Global Multicenter, Open-label, Randomized, Event-driven, Active-controlled Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement (TAVR) to Optimize Clinical Outcomes

To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE). To assess whether a rivaroxaban-based strategy, following...

Investigator:
Robert Kipperman, MD

TAVR, compared to an antiplatelet-based strategy, is non-inferior towards primary bleeding events (PBE).

GALILEO | PHASE III

Sponsor:
Bayer HealthCare Pharmaceuticals Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Successful TAVR (Transcatheter Aortic Valve Replacement) of a native aortic valve stenosis
◦ By iliofemoral or subclavian access
◦ With any approved/marketed device

Exclusion Criteria:
• Atrial fibrillation (AF), current or previous, with an ongoing indication for oral anticoagulant treatment
• Any other indication for continued treatment with any oral anticoagulant (OAC)
• Known bleeding diathesis (such as but not limited to active internal bleeding, clinically significant bleeding, platelet count ≤ 50,000/mm3 at screening, hemoglobin level < 8.5 g/dL, active peptic ulcer or known gastrointestinal (GI) bleeding, history of intracranial hemorrhage or subdural hematoma)
• Any indication for dual-antiplatelet therapy (DAPT) for more than 3 months after randomization (such as coronary, carotid or peripheral stent implantation)
• Clinically overt stroke within the last 3 months
• Planned coronary or vascular intervention or major surgery
• Severe renal impairment (eGFR < 30 mL/min/1.73 m2) or on dialysis, or post-TAVR unresolved acute kidney injury with renal dysfunction stage 2 or higher
• Moderate and severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy

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Heart Disease
Open to Enrollment

'GREAT' Global Registry for Endovascular Aortic Treatment - Outcomes Evaluation

Prospective, observational Registry to obtain data on device performance and clinical outcomes.

Investigator:
Mark Kumar, MD
GREAT

Sponsor:
W.L. Gore & Associates, Inc.

Inclusion & Exclusion Criteria:
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population
Consecutive series of patients who undergo treatment with Gore endovascular aortic products.

Inclusion Criteria:
• Minimum age required by state regulations
• Indication for aortic endovascular stent graft repair
• Signed informed consent

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Heart Disease
Open to Enrollment

Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C).

This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international.

Investigator:
Robert Fishberg, MD

This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international.

ORION | PHASE III

Sponsor:
The Medicines Company

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
Participants may be included if they meet all of the following inclusion criteria prior to randomization:
1. Male or female participants ≥18 years of age.
2. History of HeFH with a diagnosis of HeFH by genetic testing; and/or a documented history of untreated LDL-C of >190 mg/dL, and a family history of familial hypercholesterolemia, elevated cholesterol or early heart disease that may indicate familial hypercholesterolemia.
3. Serum LDL-C ≥2.6 millimoles (mmol)/liter (L) (≥100 mg/dL) at screening.
4. Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.
5. Participants on statins should be receiving a maximally tolerated dose.
6. Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.
7. Participants on lipid-lowering therapies (such as a statin and/or ezetimibe) should be on a stable dose for ≥30 days before screening with no planned medication or dose change during study participation.

Exclusion Criteria:
Participants will be excluded from the study if any of the following exclusion criteria apply immediately prior to randomization:
1. New York Heart Association (NYHA) class IV heart failure.
2. Uncontrolled cardiac arrhythmia
3. Uncontrolled severe hypertension
4. Active liver disease
5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion:
1. Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) AND more than 55 years of age.
2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.
3. Women who are surgically sterilized at least 3 months prior to enrollment.
6. Males who are unwilling to use an acceptable method of birth control during the entire study period (condom with spermicide).
7. Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.
8. Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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Heart Disease
Completed

Risk Stratification in Older Adults with Acute Myocardial Infarction (SILVER-AMI)

SILVER-AMI is a research study of older persons who are admitted to the hospital with a heart attack. Patients will be interviewed in the hospital and again 6 months later. The researchers will also collect detailed medical record information to understand...

Investigator:

the effect of heart attacks on older persons. The research team at Yale University will use this information to develop a risk model that can be used to help doctors predict recovery. The goal of the study is to help older people in the future make well-informed decisions about their health care during a heart attack.

SILVER-AMI

Sponsor:
National Institute of Health

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 75 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population: Older adults admitted to the hospital with a heart attack

Inclusion Criteria:
1. Age ≥75 years upon admission to the hospital
2. Elevation of cardiac markers within 24 hours of presentation to the hospital
3. Any one of the following:
1. Symptoms of ischemia
2. ECG with ischemic changes
3. Imaging evidence of Infarction
4. Intracoronary thrombus on angiography

Exclusion Criteria:
1. Patient transferred from another hospital with a length of stay >24 hours at the referring hospital.
2. Refused Informed Consent
3. Decisional impairment with no legally authorized representative
4. AMI is secondary to chest trauma
5. AMI is secondary to in-patient procedure or surgery
6. History of heart transplant
7. Non-English speaking
8. Inability to complete interview (e.g. comatose or aphasia)
9. Inability to contact for follow-up (e.g. no access to phone, not living in the country)
10. Currently a prisoner
11. Death prior to enrollment
12. Previously enrolled in SILVER-AMI

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Heart Disease
Open to Enrollment

St. Jude Medical Product Longevity and Performance (SCORE) Registry

SCORE is an active, prospective, non-randomized, multi-center outcome-oriented registry of patients implanted with St Jude Medical (SJM) market-released cardiac rhythm management (CRM) products. This registry will be conducted in the United States (US). The...

Investigator:
Stephen Winters, MD

primary purpose of the registry is to evaluate and publish acute and long-term performance of market-released SJM CRM products by analyzing product survival probabilities. Product status and any related adverse events will be collected to measure survival probabilities.

SCORE

Sponsor:
St. Jude Medical CRMD

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample

Any patient indicated for a cardiac rhythm management (CRM) product like ICD, pacemaker, CRT-D, CRT-P, leads, etc. would be eligible for participation in the study.

Enrollment Criteria:

- Patient has a standard indication for a CRM implantable device.
- Patient is implanted with at least one new market-released SJM CRM product from a list provided by SJM (e.g pacemaker, ICD, CRT-D, CRT-P, pacing/sensing lead, defibrillation lead) within the last 90 days.
- Complete system implant information (e.g. model, serial number, location) is available at enrollment.
- Any product-related adverse event information at implant is available at enrollment.
- Patient or appropriate legal guardian is willing to provide authorization for registry participation.

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Heart Disease
Open to Enrollment

The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.

Investigator:
Robert Kipperman, MD
CLASP

Sponsor:
Edwards Lifesciences LLC

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Signed and dated IRB/ethics committee approved study consent form prior to study related procedures
• Eighteen (18) years of age or older
• New York Heart Association (NYHA) Functional Class II-IVa heart failure despite optimal medical therapy
• Candidacy for surgical mitral valve repair or replacement determined by Heart Team evaluation
• Clinically significant mitral regurgitation (moderate-to-severe or severe mitral regurgitation) confirmed by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE).
• The primary regurgitant jet is non-commissural. If a secondary jet exists, it must be considered clinically insignificant.
• Mitral valve area (MVA) ≥ 4.0 cm² as measured by planimetry. If MVA by planimetry is not measurable, pressure half-time measurement is acceptable.

Exclusion Criteria:
• Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
• Leaflet anatomy which may preclude PASCAL device implantation, proper device positioning on the leaflets, or sufficient reduction in mitral regurgitation.
• Mitral valve area (MVA) < 4.0 cm² as measured by planimetry (If MVA by planimetry is not measurable, PHT measurement is acceptable)
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
• Physical evidence of right sided congestive heart failure and echocardiographic evidence of severe right ventricular dysfunction
• Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
• Patient is currently participating or has participated in another investigational drug or device clinical study where the primary study endpoint was not reached at time of enrollment
• Patient is under guardianship

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Heart Disease
Open to Enrollment

The OPTIMIZE Trial to Assess the Procedural and Clinical Value of the Svelte IDS and RX Sirolimus Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions in a Randomized Study

Indication for use: "The Svelte DES is indicated for improving coronary luminal diameter in patients with symptomatic heart disease, including patients with non-ST elevation MI due to discrete de novo native coronary artery lesions. The treated lesion length...

Investigator:
Jordan Safirstein, MD

should be less than the nominal stent length with a reference vessel diameter of 2.50 mm - 4.00 mm

OPTIMIZE

Sponsor:
Svelte Medical Systems, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Subject is an eligible candidate for percutaneous coronary intervention (PCI);
• Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia;
• Subject is an acceptable candidate for coronary artery bypass grafting (CABG);
• Subject has up to 3 de novo target lesions in up to 2 native coronary artery vessels, with no more than 2 lesions in a single vessel, each meeting the angiographic criteria and none of the exclusion criteria.
• Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥ 2.50 mm and ≤ 4.00 mm;

Exclusion Criteria:
• The subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina;
• The subject's target lesion(s) is located in the left main artery;
• The subject's target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate;
• The subject's target lesion(s) is located within a saphenous vein graft or arterial graft;
• The subject's target lesion(s) will be accessed via a saphenous vein graft or arterial graft;

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Heart Failure
Open to Enrollment

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)

The purpose of this study is to determine if treatment with omecamtiv mecarbil/AMG 423 when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in subjects with chronic HFrEF.

Investigator:
Marc Goldschmidt, MD

The purpose of this study is to determine if treatment with omecamtiv mecarbil/AMG 423 when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in subjects with chronic HFrEF.

GALACTIC | PHASE III

Sponsor:
Amgen, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Key Inclusion Criteria:
• Subject has provided informed consent
• Male or female, ≥ 18 to ≤ 85 years
• History of chronic HF (defined as requiring treatment for HF for a minimum of 30 days before randomization)
• LVEF ≤ 35%, per subjects most recent medical record, within 12 months prior to screening.
• NYHA class II to IV at most recent screening assessment.
• Managed with HF SoC therapies consistent with regional clinical practice guidelines according to investigator judgment of subject's clinical status
• Current hospitalization with primary reason of HF OR one of the following events within 1 year of screening: hospitalization with primary reason of HF; urgent visit to emergency department (ED) with primary reason of HF.
• Elevated BNP or NT-proBNP
Other Inclusion Criteria May apply

Key Exclusion Criteria:
• Currently receiving treatment in another investigational device or drug study, or < 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
• Malignancy within 5 years prior to randomization with the following exceptions: localized basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, stage 1 prostate carcinoma, breast ductal carcinoma in situ.
• Subject has known sensitivity to any of the products or components to be administered during testing
Other Exclusion Criteria May apply

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Heart Failure
Open to Enrollment

A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction

The purpose of this study is to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.

Investigator:
Marc Goldschmidt, MD
CLCZ696D2301 | PHASE III

Sponsor:
Novartis Pharmaceuticals Corporation - NJ

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 55 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
- Left ventricular ejection fraction (LVEF) ≥45% prior to study entry.
- Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF ≥30 days prior to study entry
- Current symptom(s) of HF
- Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram
- At least one of the following: a HF hospitalization within 9 months prior to study entry and/or an elevated NT-proBNP.

Exclusion Criteria:

- Any prior measurement of LVEF < 45%.
- Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention (PCI) within 30 days of entry.
- Patients who have had an MI, coronary artery bypass graft (CABG) or other event within the 6 months prior to entry unless an echo measurement performed after the event confirms a LVEF ≥45%.
- Current acute decompensated HF requiring therapy.
- Patients who require treatment with 2 or more of the following: an angiotensin converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB) or a renin inhibitor
- Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dl, or body mass index (BMI) > 40 kg/m2.
- Systolic blood pressure (SBP) ≥ 180 mmHg at entry, or SBP >150 mmHg and <180 mmHg at entry unless the patient is receiving 3 or more antihypertensive drugs.

Other protocol-defined inclusion/exclusion criteria may apply.

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Heart Failure
Open to Enrollment

A Prospective, Multicenter, Single-arm Study Designed to Assess the Safety of 3-month Dual Antiplatelet Therapy (DAPT) in Subjects at High Risk for Bleeding Undergoing Percutaneous Coronary Intervention (PCI) With the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System

The EVOLVE Short DAPT Study is a prospective, multicenter, single-arm study designed to assess the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with a SYNERGY Stent System.

Investigator:
Jordan Safirstein, MD
S2073 | PHASE IV

Sponsor:
Boston Scientific Corporation

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Subject is considered at high risk for bleeding, defined as meeting one or more of the following criteria at the time of enrollment:
◦≥ 75 years of age and, in the opinion of the investigator, the risk of major bleeding associated with >3 months of DAPT outweighs the benefit,
◦need for chronic or lifelong anticoagulation therapy,
◦history of major bleeding (severe/life threatening or moderate bleeding based on the GUSTO classification) within 12 months of the index procedure,
◦history of stroke (ischemic or hemorrhagic),
◦renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent),
◦platelet count ≤100,000/μL
2. Subject must be at least 18 years of age
3. Subject must have had implantation of at least one SYNERGY stent within the preceding 3 calendar days
4. Subject must be able to take study required dual antiplatelet therapy (3 months of P2Y12 inhibitor, 15 months of aspirin)
5. Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at the 3-month milestone, if eligible per protocol
6. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific procedures are performed
7. For subjects less than 20 years of age enrolled at a Japanese site, the subject/ the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed

Exclusion Criteria:
1. Subject with an indication for the index procedure of acute ST elevation MI (STEMI)
2. Subject with an indication for the index procedure of Non ST elevation MI (NSTEMI), based on the 3rd Universal MI definition
3. Subject with treatment with another coronary stent, other than SYNERGY, during the index procedure
4. Subject with planned staged procedures. (Note: Planned staged procedures are allowed if performed within 7 days and with only SYNERGY stents).
5. Subject has a known allergy to contrast (that cannot be adequately pre-medicated), the SYNERGY stent system or protocol-required concomitant medications (e.g., everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors and aspirin)
6. Subject with implantation of a drug-eluting stent within 9 months prior to index procedure
7. Subject previously treated at any time with intravascular brachytherapy
8. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
9. Subject is participating in an investigational drug or device clinical trial that has not reached its primary endpoint (Note: registry, observational, data collection studies are not exclusionary)
10. Subject intends to participate in an investigational drug or device clinical trial within 15 months following the index procedure (Note: registry, observational, data collection studies are not exclusionary)
11. Subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months, due to another condition requiring chronic P2Y12 inhibitor use
12. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months following index procedure
13. Subject is a woman who is pregnant or nursing
14. Subject with a current medical condition with a life expectancy of less than 15 months
15. Target lesion(s) is located in the left main
16. Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate
17. Subject has unprotected left main coronary artery disease ( > 50% diameter stenosis)
18. Subject with treatment of more than 2 lesions during the index procedure
19. Target lesion(s) treated during the index procedure that involves a side branch ≥ 2.0 mm in diameter by visual estimate
20. Target lesion(s) treated during the index procedure that involves a clinically significant side branch < 2.0 mm in diameter by visual estimate that has a clinically significant stenosis at the ostium
21. Target lesion(s) is restenotic from a previous stent implantation
22. Target lesion(s) is located within a saphenous vein graft or an arterial graft
23. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
24. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)

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Heart Failure
Open to Enrollment

A Prospective, Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Effects of Macitentan on Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension Assessed by Cardiac Magnetic Resonance Imaging

The study evaluates the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension. Patients are treated with macitentan for 1 year. Patients undergo right heart catheterization (RHC) at...

Investigator:
Marc Goldschmidt

baseline and Week 26. They also undergo cardiac magnetic resonance imaging (MRI) at baseline, Week 26 and Week 52. Safety is monitored throughout the study. The study has three stub-studies. Each patient can participate in no sub-study or in one sub-study. The sub-studies are: (1) metabolism sub-study (with PET-MR scans); (2) biopsy sub-study (biopsies taken during the RHC); (3) Echo sub-study.

REPAIR | PHASE IV

Sponsor:
Actelion Pharmaceuticals Ltd.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 64 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Signed informed consent prior to any study-mandated procedure
2. Symptomatic pulmonary arterial hypertension (PAH)
3. World Health Organization (WHO) Functional Class (FC) I to III
4. PAH etiology belonging to one of the following groups according to Nice classification:
◦Idiopathic PAH
◦Heritable PAH
◦Drug- and toxin-induced PAH
◦PAH associated with congenital heart diseases: only simple (atrial septal defect, ventricular septal defect, patent ductus arteriosus) congenital systemic to pulmonary shunts at least 2 year post surgical repair
5. Hemodynamic diagnosis of PAH confirmed by right heart catheterization (RHC) during screening showing:
• mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and
◦PCWP (pulmonary capillary wedge pressure) or left ventricular end diastolic pressure (LVEDP) ≤ 12 mmHg and pulmonary vascular resistance (PVR) ≥ 4 Wood Units (WU) (320 dyn.sec.cm-5) or
◦12 mmHg ≤ PCWP or LVEDP ≤ 15 mmHg and PVR ≥ 6WU (480 dyn.sec.cm-5)
6. 6-minute walk distance (6MWD) ≥ 150 m during screening
7. For patients treated with oral diuretics, treatment dose must have been stable at least 1 month prior to RHC during the screening period
8. For patients treated with phosphodiesterase type-5 (PDE-5) inhibitors, treatment dose must have been stable at least 3 months prior to RHC during the screening period
9. For patients treated with beta blockers, treatment dose must have been stable at least 1 month prior to the RHC during the screening period
10. Men or women ≥18 and < 65 years
11. Women of childbearing potential (defined in protocol) must:
◦Have a negative serum pregnancy test during screening and a negative urine pregnancy test on Day 1, and
◦Agree to use reliable methods of contraception (defined in protocol) from screening up to 30 days after study treatment discontinuation, and
◦Agree to perform monthly pregnancy tests up to 30 days after study treatment discontinuation

Exclusion Criteria:
1. Body weight < 40 kg
2. Body mass index (BMI) > 35kg/m2. For patients with 30kg/m2 < BMI < 35kg/m2, an eligibility form will be submitted to a Steering Committee member who will reserve the right to exclude the patient.
3. Pregnancy, breastfeeding or intention to become pregnant during the study
4. Recently started (< 8 weeks prior to informed consent signature) or planned cardio-pulmonary rehabilitation program
5. Known concomitant life-threatening disease with a life expectancy < 12 months
6. Any condition likely to affect protocol or treatment compliance
7. Hospitalization for PAH within 3 months prior to informed consent signature
8. Left atrial volume indexed for body surface area ≥ 43mL/m2 by echocardiography or cardiac MRI
9. Valvular disease grade 2 or higher
10. History of pulmonary embolism or deep vein thrombosis
11. Documented moderate to severe chronic obstructive pulmonary disease
12. Documented moderate to severe restrictive lung disease
13. Historical evidence of significant coronary artery disease established by:
◦History of myocardial infarction or
◦More than 50% stenosis in a coronary artery (by percutaneous coronary intervention or angiography) or
◦Elevation of the ST segment on electrocardiogram or
◦History of coronary artery bypass grafting or
◦Stable angina
14. Diabetes mellitus
15. Moderate to severe renal insufficiency (calculated creatinine clearance < 60 mL/min/1.73 m2)
16. Cancer
17. Systolic blood pressure < 90 mmHg
18. Severe hepatic impairment (with or without cirrhosis) according to National Cancer Institute organ dysfunction working group criteria, defined as total bilirubin > 3 × upper limit of the normal range (ULN) accompanied by an aspartate aminotransferase (AST) elevation > ULN at Screening.
19. Hemoglobin < 100g/L
20. AST and/or alanine aminotransferase (ALT) > 3× ULN
21. Need for dialysis
22. Responders to acute vasoreactivity test based on medical history
23. Prior use of endothelin receptor antagonists (ERAs), stimulators of soluble guanylate cyclase or prostacyclin or prostacyclin analogues
24. Treatment with strong inducers of cytochrome P450 isozyme 3A4 (CYP3A4) within 4 weeks prior to study treatment initiation (e.g., carbamazepine, rifampicin, rifabutin, phenytoin and St. John's Wort)
25. Treatment with strong inhibitors of CYP3A4 within 4 weeks prior to study treatment initiation (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir)
26. Treatment with another investigational drug (planned, or taken within the 3 months prior to study treatment initiation).
27. Hypersensitivity to any ERA or any excipients of the formulation of macitentan (lactose, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, polyvinyl alcohol, polysorbate, titanium dioxide, talc, xanthan gum, and lecithin soya)
28. Claustrophobia
29. Permanent cardiac pacemaker, automatic internal cardioverter
30. Metallic implant (e.g., defibrillator, neurostimulator, hearing aid, permanent use of infusion device)
31. Atrial fibrillation, multiple premature ventricular or atrial contractions, or any other condition that would interfere with proper cardiac gating during MRI.
32. For patients enrolling in the metabolism sub-study only: glucose intolerance
33. For patients enrolling in the biopsy sub-study only: PAH etiology belonging to Nice classification 1.4.4: PAH associated with congenital heart diseases

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Heart Failure
Open to Enrollment

Annular ReduCtion for Transcatheter Treatment of Insufficient Mitral ValvE (ACTIVE): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Assess Transcatheter Mitral Valve Repair With Edwards Cardioband System and GDMT vs GDMT Alone in Patients With FMR and Heart Failure

To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).

Investigator:
Robert Kipperman, MD
ACTIVE

Sponsor:
Edwards Lifesciences LLC

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Age > 18 years;
• Clinically Significant Functional Mitral Regurgitation (MR);
• Symptomatic heart failure;
• Patient hospitalized due to heart failure during 12 months prior to submission to Central Screening Committee OR elevated Brain Natriuretic Peptid (BNP);
• Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit compliance.

Exclusion Criteria:
• Primarily degenerative MR;
• Mitral annular calcification that would impede implantation of device;
• Other severe valve disorders requiring intervention;
• Mitral valve anatomy which may preclude proper Edwards Cardioband deployment;
• Life expectancy of less than twelve months;
• Patient is participating in concomitant research studies of investigational products which have not reached their primary endpoint;
• Unwillingness or inability to undergo follow-up investigations/visits;
• Other medical, social, or psychological conditions that precludes appropriate consent and follow-up

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Heart Failure
Open to Enrollment

Attain Stability™ Quad Clinical Study

The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability Quadripolar MRI SureScan Left Ventricular (LV) lead (Model 4798).

Investigator:
Robert Coyne, MD
Attain QUAD

Sponsor:
Medtronic, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Patient meets CRT implant criteria as determined by local regulatory and/or hospital policy (i.e. US subjects should meet CRT device indications per the HRS/ACC/AHA guidelines)
• Patient (or legally authorized representative) has signed and dated the study-specific Informed Consent Form
• Patient is 18 years of age or older, or is of legal age to give informed consent per local and national law
• Patient is expected to remain available for follow-up visits

Exclusion Criteria:
• Patient has had a previous unsuccessful LV lead implant attempt
• Patient has a previous CRT system or LV lead implanted (for example, transvenous or epicardial)
• Patient is currently implanted with a recalled (i.e. market-withdrawn, recalled or safety alert) RA and/or RV lead
• Patient has known coronary venous vasculature that is inadequate for lead placement
• Patient has unstable angina pectoris or has had an acute myocardial infarction (MI) within the past 30 days
• Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past 90 days
• Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve)
• Patient has had a heart transplant (patients waiting for heart transplants are allowed in the study)
• Patient has known renal insufficiency that would prevent them from receiving an occlusive venogram during the implant procedure
• Patient is contraindicated for <1mg dexamethasone acetate
• Patient is enrolled in any concurrent drug and/or device study that may confound the results of this study
• Patient has a terminal illness and is not expected to survive more than six months
• Patient meets exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc.)
• Patient is unable to tolerate an urgent thoracotomy

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Heart Failure
Open to Enrollment

CardioMEMS HF System Post Approval Study

The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.

Investigator:
Marc Goldschmidt, MD
CardioMEMS

Sponsor:
St. Jude Medical CRMD

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population

patients with NYHA class III heart failure
Criteria

Inclusion Criteria:
- Diagnosis of NYHA class III heart failure
- At least 1 heart failure hospitalization within previous 12 months
- Patients with reduced LVEF heart failure should be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the patient is intolerant to beta blockers, ACE-I or ARB
- BMI ≤ 35. Patients with BMI >35 will require their chest circumference to be measured at the axillary level. If > 65 inches the patient will not be eligible for the study.
- Pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the right heart catheterization)

Exclusion Criteria:
- Active infection
- History of recurrent (> 1) pulmonary embolism or deep vein thrombosis
- Inability to tolerate a right heart catheterization
- A major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within previous 2 months
- Cardiac resynchronization device (CRT) implanted within previous 3 months
- Glomerular Filtration Rate (GFR) < 25 ml/min (obtained within 2 weeks of implant) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
- Congenital heart disease or mechanical right heart valve
- Likely to undergo heart transplantation or VAD within the next 6 months
- Known coagulation disorders
- Hypersensitivity or allergy to aspirin, and/or clopidogrel

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Heart Failure
Completed

Late Sodium Current Blockade in High-Risk ICD Patients

The purpose of the study is to see how effective a drug called ranolazine is in reducing the risk of ventricular arrhythmia and death in people with implantable cardioverter-defibrillators (ICDs). This drug will be used with standard medications that is routinely...

Investigator:
Stephen Winters, MD

prescribed in enrolled patients.

RAID

Sponsor:
National Institute of Health

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 21 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1,440 high-risk patients with ischemic/nonischemic cardiomyopathy who receive their ICDs as standard of care for primary or secondary prevention of mortality following approved indications for ICD therapy. High-risk patients will be defined as:

Secondary Prevention Patients Subjects with ischemic or nonischemic cardiomyopathy, qualified for or with existing ICD (or CRT-D) after documented VT/VF or cardiac arrest (secondary prevention of mortality). Secondary prevention subjects with existing implants are eligible regardless of when the implant was received (subjects could be recruited from outpatient clinics or from inpatient activity including during re-implant or other procedures).

Primary Prevention Patients

1. Patients with primary prevention indications for ischemic or non-ischemic cardiomyopathy with EF≤35%, with existing devices (ICD/CRT-D), regardless of when the device was implanted, who have experienced at least ONE episode of VT/VF appropriately treated with ICD therapy (ATP or shock) or had untreated NSVT lasting at least 10 beats with heart rate of at least 170 bpm, documented by electrogram of their implanted device.
2. Patients with ischemic or non-ischemic cardiomyopathy with EF≤35%, who have been implanted within the last 2 years (initial ICD/CRT-D implants, including upgrades from pacemakers) who have NOT experienced VT/VF treated with ICD therapy (ATP or shock), AND who have ONE of the following additional criteria: BUN≥26 mg/dl or QRS>120ms or Atrial Fibrillation or NSVT documented by ECG/Holter or >500 Ventricular Premature Beats (VPBs)documented in a 24-hour Holter.
o Stable optimal pharmacologic therapy for the cardiac condition
o Age: equal to 21 years without upper limit

Exclusion Criteria:
• Patient receiving first device with coronary artery bypass graft surgery within the last 3 calendar months prior to date consent obtained
• Patients receiving first device with percutaneous coronary intervention within the last 1 calendar month prior to date consent obtained
• Patient receiving first device with enzyme-positive myocardial infarction with the past 3 calendar months prior to date consent obtained
• Patient receiving first device with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the foreseeable future
• Patient in NYHA Class IV
• Patients receiving prophylactic ablation of ventricular substrate
• Patients with preexisting QTc prolongation >550ms
• Patients on strong CYP3A inhibitors (including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir and saquinavir and moderate CYP3A inhibitors, including, diltiazem, verapamil, aprepitant, erythromycin, fluconazole and grapefruit juice or grapefruit-containing products.
• Patients on CYP3A inducers such as rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine and St.John's wort
• Patients with inherited arrhythmia disorders such as Brugada's, ARVD, LQTS or hypertrophic cardiomyopathy
• Patient who is pregnant or plans to become pregnant during the course of the trial (patients at child bearing age who use prescribed pharmaceutical contraceptives could be enrolled)
• Patient with irreversible brain damage from preexisting cerebral disease
• Patient with presence of any disease, other than the patient's cardiac disease, associated with a reduced likelihood of survival for the duration of the trial, e.g., cancer, uremia, liver failure, etc.
• Patient with chronic renal disease with creatinine >2.5 mg/dl
• Patient participating in any other clinical trial
• Patient unwilling or unable to cooperate with the protocol
• Patient who lives at such a distance from the clinic that travel for follow-up visits would be unusually difficult
• Patient who does not anticipate being a resident of the area for the scheduled duration of the trial
• Patients who are decisionally impaired adults, those of questionable capacity, and those who cannot consent for themselves will not be recruited for this study.
• Patient unwilling to sign the consent for participation

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Heart Failure
Open to Enrollment

Percutaneous Mitral Valve Replacement EvaLuation Utilizing IDE Early Feasibility Study (PRELUDE)

The purpose of this study is to assess the safety and performance of the Caisson Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of severe symptomatic MitralValve Regurgitation (MR).

Investigator:
Robert Kipperman, MD
PRELUDE | PHASE I

Sponsor:
Caisson Interventional, LLC

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Has severe mitral regurgitation
• New York Heart Association (NYHA) Class II, III, IVa or heart failure
• High risk for cardiovascular surgery

Exclusion Criteria:
• Excessive calcification or thickening of mitral valve annulus, severe mitral stenosis, fused commissures, valvular vegetation or mass
• Left ventricular end diastolic dimension > 7cm
• Left ventricular outflow tract obstruction
• Severe right ventricular dysfunction
• Stroke within 90 days; transischemic attack or myocardial infarction within 30 days of the index procedure

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Heart Failure
Open to Enrollment

Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy in Patients With Post Myocardial Infarction Heart Failure (CardiAMP Heart Failure Trial)

This is a prospective, multi-center, randomized (3 Treatment : 2 Sham Control), sham-controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy to a sham treatment. A roll-in phase with a maximum of 10 subjects will...

Investigator:
Marc Goldschmidt, MD

precede the randomised phase.

BC-14-001-02 | PHASE III

Sponsor:
BioCardia, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 21 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Greater than (>) 21 and less than (<) 90 years of age.
• New York Heart Association (NYHA) Class II or III.
• A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI).
• Have an ejection fraction ≥ 20% and ≤ 40%.
• On stable evidence-based medical and device therapy for heart failure or post-infarction left ventricular dysfunction, per the 2013 ACC/AHA Heart Failure guidelines, for at least three (3) months prior to randomization.
• Cell Potency Assay Score of 3, as determined by the Cell Analysis Core Lab results.
• Provide written informed consent.

Exclusion Criteria:
• Have a baseline glomerular filtration rate <50 ml/min/1.73m2.
• Have a hematological abnormality as evidenced by hematocrit < 25%, white blood cell < 2,500/ul or platelet values, <100,000/ul without another explanation.
• Have liver dysfunction, as evidenced by enzymes (AST and LT) greater than three times the ULN.
• Have a coagulopathy (INR ≥ 1.3) not due to a reversible cause (i.e., Coumadin). Patients on Coumadin will be withdrawn before the procedure and confirmed to have an INR <1.3. Patients who cannot be withdrawn from Coumadin will be excluded from enrollment.
• Be an organ transplant recipient.
• Have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.
• Be serum positive for hepatitis B/C and or HIV, unless patient is a carrier for Hepatitis B/C, but has never had an active flare.
• History of bronchospastic lung disease (asthma or chronic obstructive pulmonary disease), orthopedic, muscular or neurologic conditions that could limit the ability to perform 6 Minute Walk Distance Test.
• Have a known, serious radiological contrast allergy.
• Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods for at least 30 days prior to randomization.
• Not a candidate for cardiac catheterization.

Cardiac or Vascular System
• Require coronary artery revascularization. Patients who require or undergo revascularization procedures would undergo these procedures a minimum of 3 months in advance of randomization.
• Have a left ventricle thrombus, as detected by the echocardiographic core laboratory.
• Have mitral regurgitation, defined as "severe", as measured by the echocardiographic core laboratory.
• Have a mechanical aortic valve or heart constrictive device.
• Have severe mitral or tricuspid insufficiency.
• Have a documented presence of aortic stenosis (aortic stenosis graded as > + 2 equivalent to an orifice area of 1.5cm2 or less), as detected by the echocardiographic core laboratory.
• Have a documented presence of aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥ + 2).
• Acute coronary syndrome within 3 months.
• Have evidence of a life-threatening arrhythmia (non-sustained ventricular tachycardia ≥ 20 consecutive beats) or sustained or short run (>20 consecutive beats) ventricular tachycardia during the screening Holter Monitoring.
• AICD firing in the past 60 days prior to the procedure.
• Have peripheral artery disease involving the aorta or iliofemoral system that impacts the feasibility or safety of the study intervention. This includes stenotic or aneurysmal or embolic disease, and symptom limiting claudication.
• Have complete heart block or QTc interval >550 ms on screening 12-lead ECG.

Other
• Have a non-cardiac condition that limits lifespan to < 1 year.
• Have a history of drug or alcohol abuse within the past 24 months.
• Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial or participated in the treatment arm of a gene or stem cell therapy trial within the previous 12 months.
• Unwilling or unable to comply with follow-up.

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Heart Failure
Open to Enrollment

REDUCE LAP-HF TRIAL: A Study to Evaluate the DC Devices, Inc. IASD™ System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure

The objective of this clinical study is to evaluate the safety and performance of the IASD System II in the treatment of heart failure patients with elevated left atrial pressure, who remain symptomatic despite appropriate medical management.

Investigator:
Marc Goldschmidt, MD
REDUCE LAP-HF

Sponsor:
Corvia Medical, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 40 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Key Inclusion Criteria:
1. Chronic symptomatic Heart Failure (HF) documented by one or more of the following:
1. New York Heart Association (NYHA) Class II/III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit; or signs (Any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months;
2. One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify);
3. On-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 ESC Guidelines for diagnosis and Treatment of Acute and Chronic Heart Failure).
2.Age ≥ 40 years old
3.Left ventricular ejection fraction (obtained by echocardiography) ≥ 40%
4. Elevated left ventricular filling pressures with a gradient compared to CVP documented by :
1. PCWP or LVEDP at rest ≥ 15 mmHg, and greater than CVP, OR
2. PCWP during supine bike exercise ≥ 25mm Hg, and CVP < 20 mm Hg

Key Exclusion Criteria:
3. Severe heart failure defined as:
1. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
2. Fick Cardiac Index < 2.0 L/min/m2
3. Requiring inotropic infusion (continuous or intermittent) within the past 6 months
4. Patient is on the cardiac transplant waiting list 4. Inability to perform 6 Minute Walk Test 5. Known significant coronary artery disease (stenosis >70%) 6. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months 7. Known severe carotid artery stenosis (> 70%) 8. Presence of significant valve disease defined by echocardiography as: a) Mitral valve regurgitation defined as grade >2+ MR b) Tricuspid valve regurgitation defined as grade ≥ 2+ TR; c) Aortic valve disease defined as ≥ 2+ AR or moderate AS

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Kidney Cancer
Open to Enrollment

A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti−PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy

This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.

Investigator:
Gregg Zimmerman, MD
WO39210 | PHASE III

Sponsor:
Genentech, Inc

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• ECOG performance status of less than or equal to (• Pathologically confirmed RCC with a component of either clear cell histology or sarcomatoid histology that has not been previously treated in the adjuvant or neoadjuvant setting and classified as being at high risk of RCC recurrence
• Radical or partial nephrectomy with lymphadenectomy in select participants
• Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization.
• Absence of brain metastasis, as confirmed by a negative CT with contrast or magnetic resonance imaging (MRI) scan of the brain, no more than 4 weeks prior to randomization. Applicable only to metastasectomy participants
• Full recovery from nephrectomy or metastasectomy within 12 weeks from randomization following surgery

Exclusion Criteria:
• Bilateral synchronous tumors with inheritable forms of RCC including von Hippel-Lindau
• Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
• Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days or five half-lives of the investigational agent, whichever is longer, prior to enrollment
•Malignancies other than RCC within 5 years prior to Cycle 1, Day 1
• Participants with prior allogeneic stem cell or solid organ transplantation
• History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan
• Positive test for HIV
• Participants with active hepatitis B or hepatitis C
• Active tuberculosis
• Severe infections within 4 weeks prior to randomization including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
• Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
• Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
• Prior treatment with cluster of differentiation (CD)137 agonists, anti-cytotoxic T-lymphocyte-associated protein-4 (anti-CTLA-4), anti-programmed death-1 (anti-PD−1), or anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibody or pathway-targeting agents
• Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to randomization
• Treatment with systemic immunosuppressive medications (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti−tumor necrosis factor agents) within 2 weeks prior to randomization or anticipated need for systemic immunosuppressive medications during the study

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Kidney Cancer
Open to Enrollment

A Randomized Phase 2 Trial of Axitinib and TRC105 Versus Axitinib Alone (Including a lead-in Phase 1B Dose Escalation Portion) in Patients With Advanced or Metastatic Renal Cell Carcinoma

Phase 1b: To evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose axitinib in patients with advanced renal cell carcinoma. Phase 2: To estimate the PFS of patients with advanced or metastatic RCC...

Investigator:
Eric Whitman, MD

by RECIST 1.1 criteria in patients treated with axitinib and TRC105 compared to those treated with axitinib alone, following failure of one prior VEGF TKI.

105RC101 | PHASE II

Sponsor:
Tracon Pharmaceuticals, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:

- Histologically confirmed advanced or metastatic renal cell carcinoma with a clear cell component that has progressed by investigator assessment following treatment with one and only one multi-targeted tyrosine kinase inhibitor (TKI) other than axitinib that targets the VEGF receptor (VEGFR) (e.g., sunitinib, pazopanib, sorafenib, tivozanib, cabozantinib). One prior immunotherapy (interleukin-2 or interferon-alpha or immune checkpoint inhibitor or tumor vaccine) and one prior mTOR inhibitor treatment are allowed.
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission per investigators' clinical judgment.
- Measurable disease by RECIST 1.1 criteria
- Age of 18 years or older
- ECOG performance status ≤ 1
- Resolution of all acute adverse events resulting from prior cancer therapies to NCI CTCAE grade ≤ 1 or baseline (except alopecia)
- Adequate organ function as defined by the following criteria:
- Willingness and ability to consent for self to participate in study
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

- Prior treatment with TRC105 or axitinib or any agent targeting the endoglin pathway (including a fusion protein that binds bone morphogenic protein)
- Grade 3 or 4 toxicity related to prior VEGFR TKI that did not resolve to grade 1
- Current treatment on another therapeutic clinical trial
- Receipt of a small molecule anticancer agent, including an investigational anticancer small molecule, within 14 days of starting study treatment or receipt of a biologic anticancer agent (e.g., antibody) within 28 days of starting study treatment.
- Prior radiation therapy within 28 days of starting the study treatment, except radiation therapy for bone metastases or radiosurgery is permitted up to 14 days of starting treatment
- No major surgical procedure or significant traumatic injury within 6 weeks prior to study registration, and must have fully recovered from any such procedure; date of surgery (if applicable). Note: the following are not considered to be major procedures and are permitted up to 7 days before therapy initiation: Thoracentesis, paracentesis, port placement, laparoscopy, thorascopy, tube thoracostomy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, incisional biopsies, imaging-guided biopsy for diagnostic purposes, and routine dental procedures
- Uncontrolled chronic hypertension defined as systolic > 150 or diastolic > 90 despite optimal therapy (initiation or adjustment of BP medication prior to study entry is allowed provided that the average of 3 BP readings at a visit prior to enrollment is < 150/90 mm Hg)
- History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. Patients with radiated or resected lesions are permitted, provided the lesions are fully treated and inactive, patients are asymptomatic, and no steroids have been administered for at least 28 days.
- Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, PTCA or CABG within the past 6 months. Deep venous thrombosis within 6 months unless the patient is anticoagulated without the use of warfarin for at least 2 weeks. In this situation, low molecular weight heparin is preferred.
- Active bleeding or pathologic condition that carries a high risk of bleeding (e.g. hereditary hemorrhagic telangiectasia).
- Thrombolytic use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy
- Known active viral or nonviral hepatitis or cirrhosis
- History of hemorrhage or hemoptysis (> ½ teaspoon bright red blood) within 3 months of starting study treatment
- History of peptic ulcer disease within 3 months of treatment, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment
- History of gastrointestinal perforation or fistula in the past 6 months, or while previously on antiangiogenic therapy, unless underlying risk has been resolved (e.g., through surgical resection or repair)
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
- Requirement for concomitant medications that strongly induce or inhibit CYP3A4/5
- Pregnancy or breastfeeding. Female patients must be surgically sterile (i.e.: hysterectomy) or be postmenopausal, or must agree to use effective contraception during the study and for 3 months following last dose of TRC105. All female patients of reproductive potential must have a negative pregnancy test (serum or urine) within 7 days prior to first dose. Male patients must be surgically sterile or must agree to use effective contraception during the study and for 3 months following last dose of TRC105. The definition of effective contraception will be based on the judgment of the Principal Investigator or a designated associate.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this study

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Kidney Cancer
Open to Enrollment

EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study

This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery.

Investigator:
Bonni Guerin, MD
S0931 | PHASE III

Sponsor:
Southwest Oncology Group

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:
•Histologically or cytologically confirmed renal cell carcinoma
◦Clear cell or non-clear cell allowed
◾No disease of the collecting duct or medullary carcinoma
◦Considered pathologically either intermediate high-risk or very high-risk disease
◦No history of distant metastases
◦Patients with microvascular invasion of the renal vein of any grade or stage (as long as M0) are eligible
•Have undergone a full surgical resection (radical nephrectomy or partial nephrectomy) including removal of all clinically positive nodes
◦Surgical margins must be negative
◾Patients with positive renal vein margins are eligible unless there is invasion of the renal vein wall at the margin (provided no other margins are positive)
◦Patients must be registered within 84 days after the date of the first surgical resection of the first tumor
•No evidence of residual or metastatic renal cell cancer on CT scan of the chest, abdomen, and pelvis (all with oral and IV contrast) performed after nephrectomy and within 28 days before registration
◦MRI scans of the abdomen and pelvis with gadolinium and a non-contrast CT scan of the chest may be substituted if the patient is not able to have CT scans with IV contrast


PATIENT CHARACTERISTICS:
•Zubrod performance status 0-1
•ANC ≥ 1,500/mm^3
•Platelet count ≥ 100,000/mm^3
•Serum creatinine ≤ 2.0 times upper limit of normal (ULN) OR calculated creatinine clearance ≥ 30 mL/min
•Bilirubin ≤ 1.5 times ULN
•SGOT and SGPT ≤ 2.5 times ULN
•Not pregnant or nursing
•Fertile patients must use effective contraception during and for up to 8 weeks after completion of study treatment
•Able to take oral medications
•Patients must not have any of the following:
◦NYHA class III-IV cardiac disease (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort)
◦Unstable angina pectoris
◦Myocardial infarction within the past 6 months
◦Serious uncontrolled cardiac arrhythmia
•Patients must NOT have liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C)
•HBV and HCV testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
•Must be able to take oral medications
•No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
•No known history of HIV seropositivity
•No known uncontrolled, underlying pulmonary disease (spirometry and DLCO ≤ 50% of predicted OR oxygen saturation ≤ 88% at rest on room air)
•No uncontrolled hyperlipidemia (fasting serum cholesterol > 300 mg/dL AND fasting triglycerides > 2.5 times ULN) obtained within 28 days prior to registration
◦Optimal lipid control must be achieved before registration and monitored during protocol treatment
•No uncontrolled diabetes mellitus (defined by fasting serum glucose > 1.5 times ULN) obtained within 28 days prior to registration.
◦Optimal glucose control must be achieved before registration and monitored during protocol treatment
•No prior malignancies except for any of the following:
◦Adequately treated basal cell or squamous cell skin cancer
◦In situ cervical cancer
◦Adequately treated stage I or stage II cancer from which the patient is currently in complete remission
◦Any other cancer from which the patient has been disease-free for 5 years
•No known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to their excipients
•No contraindications to receiving either IV iodine-based contrast or gadolinium

PRIOR CONCURRENT THERAPY:
•See Disease Characteristics
•Patients must have recovered from any surgery-related complications
•No prior anticancer therapy for renal cell carcinoma including systemic therapy in the adjuvant or neoadjuvant setting, immunotherapy, investigational therapy, surgical metastasectomy, or radiotherapy
•More than 14 days since prior and no concurrent strong CYP3A4 inhibitors (i.e., ketoconazole, itraconazole, voriconazole, posaconazole, fluvoxamine, nefazodone, nelfinavir, or ritonavir) or strong CYP3A4 inducers (i.e., phenytoin, rifampin, or rifabutin)
•More than 7 days since prior and no concurrent live vaccines
•No other concurrent anticancer agents including investigational agents
•No concurrent chronic treatment with systemic steroids or another immunosuppressive agent
◦Topical or inhaled corticosteroids are allowed

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Kidney Disease
Open to Enrollment

An Open-Label, Randomized, Parallel Group Study to Assess the Safety and Efficacy of Hectorol® (Doxercalciferol Capsules) in Pediatric Patients With Chronic Kidney Disease Stages 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis

Primary Objective: Evaluate the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH). Secondary Objectives: •Evaluate the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol) capsules. •Determine...

Investigator:
Howard Corey, MD

the pharmacokinetic profile of 1,25-dihydroxyvitamin D2 after administration of Hectorol®.

LPS14314 | PHASE III

Sponsor:
Sanofi US Services Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 5 Years to 18 Years (Child, Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion criteria:
• Male or female aged 5 to 18 years old.
• Weight ≥15 kg.
• Chronic kidney disease (CKD) Stage 3 or 4 not on dialysis, defined as glomerular filtration rate (GFR) between 15 and 59 mL/min/1.73m^2 (established by Schwartz equation) at Week -2 visit.
• Intact parathyroid hormone (iPTH) value >100 pg/mL for CKD Stage 3 or >160 pg/mL for CKD Stage 4, at Week -2 visit.
• Signed informed consent/assent form.

Exclusion criteria:
• The patient has a serum 25-hydroxyvitamin D level <30 ng/mL at screening.
• The patient has a corrected calcium ≥10 mg/dL at the Week -2 visit.
• The patient has a serum phosphorus >4.5 mg/dL for children 13 to 18 years of age; >5.8 mg/dL for children 5 to 12 years of age at the Week -2 visit.
• The patient is anticipated to require maintenance hemodialysis within 3 months.
• The patient used cinacalcet or vitamin D sterol therapies such as calcitriol, doxercalciferol, or paricalcitol within 14 days prior to the baseline visit.
• The patient has a history of, or active, symptomatic heart disease within 12 months prior to the baseline (Week 0) visit.
• The patient currently has a chronic gastrointestinal disease (ie, malabsorption, severe chronic diarrhea, chronic ulcerative colitis, or ileostomy).
• The patient currently has primary hyperparathyroidism or has had a total parathyroidectomy.
• The patient has an active malignancy.
• The patient is unable to swallow a capsule in size similar to the Hectorol® and Rocaltrol® capsules.
• The patient has a history of sensitivity or allergy to doxercalciferol, calcitriol or other vitamin D analogs.
• The patient currently uses aluminum or magnesium-based binders.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Liver Cancer
Open to Enrollment

A Phase 3 Randomized, Open-Label Study Comparing Pexa Vec (Vaccinia GM CSF / Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy

This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not...

Investigator:
Lawrence Harrison, MD

received prior systemic therapy.

JX594-HEP024 | PHASE III

Sponsor:
SillaJen Biotherapeutics, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Histological/cytological diagnosis of primary HCC
• Advanced stage HCC (Barcelona Clinic Liver Cancer [BCLC] Stage C or B per American Association for the Study of Liver Disease [AASLD] guidelines)
• At least one measurable viable tumor in the liver, ≥1 cm longest diameter (LD), using a dynamic imaging technique (arterial phase of triphasic computerized tomography [CT] scan, or dynamic contrast-enhanced magnetic resonance imaging [MRI]), and injectable under imaging-guidance (CT and/or ultrasound)
• Child-Pugh Class A
• Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
• Adequate hematological, hepatic, and renal function:
• Additional inclusion criteria exist

Exclusion Criteria:
• Histological diagnosis of cholangiocarcinoma, hepatocholangiocarcinoma, fibrolamellar carcinoma and hepatoblastoma
• Symptomatic cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months
• Current or past history of cardiovascular disease (e.g.. past history of myocardial infarction, ischemic cardiomyopathy) unless cardiology consultation and clearance has been obtained for study participation
• History of moderate or severe ascites, bleeding esophageal varices, hepatic encephalopathy or pleural effusions related to liver insufficiency within 6 months of screening
• Bulky disease patients - tumors encompassing >50% of the liver volume and / or inferior vena cava invasion
• Known significant immunodeficiency due to underlying illness (e.g., HIV/AIDS) and/or immune-suppressive medication including high-dose corticosteroids
• Ongoing severe inflammatory skin condition (as determined by the Investigator) requiring medical treatment
• History of severe eczema (as determined by the Investigator) requiring medical treatment
• Additional exclusion criteria exist

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Lung Cancer
Open to Enrollment

A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combination with Anti-PD-L1 Inhibitor Duravalumab (MEDI4736) in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

This study is a Phase 2, open-label, 2-cohort, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) alone, (Cohort 1), or in combination with durvalumab (anti-programmed cell death ligand 1 [PD-L1] monoclonal antibody...

Investigator:
Missak Haigentz, MD

[mAb]) (Cohort 2).

IOV-LUN-201 | PHASE II

Sponsor:
Iovance Biotherapeutics, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Confirmed diagnosis of Stage III or Stage IV NSCLC and have received ≥ 1 line of prior systemic therapy in the locally advanced or metastatic setting
• Have at least 1 resectable lesion to generate TIL
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
• Male or female, ≥ 18 years of age
• Body weight > 30 kg
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of ≥ 3 months
• Adequate bone marrow function at screening
• Adequate organ function at screening
• If the patient is of childbearing potential or their partner(s) is of childbearing potential, they must agree to use highly effective method of contraception while on study and for 6 months after receiving all protocol-related therapy.

Exclusion Criteria:
• Must not have a history of other malignancies, except for adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 3 years
• Patients may not have received prior cell therapy
• Patients may not have received prior anti PD-1 or anti PD-L1 inhibitors
• Active or prior documented autoimmune or inflammatory disorders
• History of primary immunodeficiency, history of allogeneic organ transplant that requires therapeutic immunosuppression
• Received live or attenuated vaccination within 28 days prior to the start of NMA-LD
• History of hypersensitivity to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO) or IL-2
• Known allergic reaction to antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin)
• Mean QT interval ≥ 470 msec
• Decreased cardiac function as evidenced by a left ventricular ejection fraction of < 45%
• Uncontrolled intercurrent illness
• Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of ≤ 60%
• Active central nervous system metastases and/or leptomeningeal disease
• Current or prior use of immunosuppressive medication within 28 days before the first study treatment

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Lung Cancer
Open to Enrollment

A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-small Cell Lung Cancer: Crizotinib Versus Placebo for Patients With Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

This randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase...

Investigator:
Missak Haigentz, MD

(ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.

E4512 | PHASE III

Sponsor:
Eastern Cooperative Oncology Group

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Patients must have undergone complete surgical resection of their stage IB (>= 4 cm), II, or non-squamous IIIA NSCLC per American Joint Committee on Cancer (AJCC) 7th edition and have had negative margins; N3 disease is not allowed
• Baseline chest computed tomography (CT) with or without contrast must be performed within 6 months (180 days) prior to randomization to ensure no evidence of disease; if clinically indicated additional imaging studies must be performed to rule out metastatic disease
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization
• Positive for translocation or inversion events involving the ALK gene locus (e.g. resulting in echinoderm microtubule associated protein like 4 [EML4]-ALK fusion) as determined by the Vysis Break Point fluorescence in situ hybridization (FISH) assay and defined by an increase in the distance between 5' and 3' ALK probes or the loss of the 5' probe; this must have been performed:
◦ By a local Clinical Laboratory Improvement Amendments (CLIA) certified laboratory: report must indicate the results as well as the CLIA number of the laboratory which performed the assay; tissue must be available for submission for central, retrospective confirmation of the ALK fusion status via ALCHEMIST-SCREEN (ALLIANCE A151216) OR
◦ Patient registered to and the ALK fusion status performed centrally on the ALCHEMIST-SCREEN (ALLIANCE A151216)
• Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood or urine pregnancy test within 72 hours prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Women of childbearing potential and sexually active males must be strongly advised to practice abstinence or use an accepted and effective method of contraception
• Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• No known interstitial fibrosis or interstitial lung disease
• No prior treatment with crizotinib or another ALK inhibitor
• No ongoing cardiac dysrhythmias of grade >= 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, uncontrolled atrial fibrillation (any grade), or corrected QT (QTc) interval > 470 msec
• No use of medications, herbals, or foods that are known potent cytochrome P450, subfamily 3A, polypeptide 4 (CYP3A4) inhibitors or inducers, included but not limited to those outlined
• Patients must be adequately recovered from surgery at the time of randomization
• The minimum time requirement between date of surgery and randomization must be at least 4 weeks (28 days)
• The maximum time requirement between surgery and randomization must be:
◦ 3 months (90 days) if no adjuvant chemotherapy was administered
◦ 8 months (240 days) if adjuvant chemotherapy was administered
◦ 10 months (300 days) if adjuvant chemotherapy and radiation therapy were administered
• Patients must have completed any prior adjuvant chemotherapy or radiation therapy 2 or more weeks (6 or more weeks for mitomycin and nitrosoureas) prior to randomization and be adequately recovered at the time of randomization
◦ NOTE: Patients taking low dose methotrexate for non-malignant conditions and other cytotoxic agents for non-malignant conditions are allowed to continue treatment while on study
◦ NOTE: Neo-adjuvant chemotherapy or radiation therapy for the resected lung cancer is not permitted
• Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
• Total serum bilirubin =< 1.5 x ULN
• Absolute neutrophil count (ANC) >= 1500/mm^3
• Platelets >= 30,000/mm^3
• Hemoglobin >= 8.0 g/dL
• Serum creatinine =< 2 x ULN
• Prior to randomization patients with any non-hematologic toxicity from surgery, chemotherapy, or radiation must have recovered to grade =< 1 with the exception of alopecia and the criteria outlined
• Patients must not have any history of cancer within 5 years from randomization, with the exception of in-situ carcinomas and non-melanoma skin cancer
• Patients may not be receiving any other investigational agents while on study

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Lung Cancer
Open to Enrollment

A Phase III, Open-label, Randomized Study to Investigate the Efficacy and Safety of MPDL3280A (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-based Chemotherapy in PD-L1-Selected Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer

The primary efficacy objective of the study is to evaluate the efficacy of 16 cycles of Atezolizumab (MPDL3280A) treatment compared with best supportive care as measured by disease-free survival (DFS) as assessed by the investigator.

Investigator:
Dennis Lowenthal, MD
GO29527 | PHASE III

Sponsor:
Genentech, Inc

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:

Inclusion Criteria for Enrollment Phase:
• Age >/= 18 years
• Ability to comply with protocol
• ECOG performance status of 0 or 1
• Histological or cytological diagnosis of Stage IB (tumors >/= 4 cm) -IIIA (T2-3 N0, T1-3 N1, T1-3 N2) NSCLC (per the UICC/AJCC staging system, 7th edition; Detterbeck et al. 2010)
• Patients must have had complete resection of NSCLC 6-12 weeks (>/= 42 days and • Complete mediastinal lymph node dissection (MLND) is required. If mediastinoscopy was not performed preoperatively, it is required that, at a minimum, mediastinal lymph node systematic sampling will have occurred. Systematic sampling is defined as removal of at least one representative lymph node at specified levels. MLND entails resection of all lymph nodes at those same levels. For a right thoracotomy, sampling or MLND is required at levels 4 and 7 and for a left thoracotomy, levels 5 and/or 6 and 7. If there is clear documentation in the operative report or in a separately submitted addendum by the surgeon of exploration of the required lymph node areas, the patient will be considered eligible if no lymph nodes are found in those areas. If patients have documented N2 disease in one level (per the UICC/AJCC staging system, 7th edition; Detterbeck et al. 2010), not all levels need to be sampled.
• Eligibility to receive a cisplatin-based chemotherapy regimen
• Adequate hematologic and end-organ function, defined by the following laboratory results obtained within 14 days prior to enrollment
• Women who are not postmenopausal (>/= 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of cisplatin-based chemotherapy.

Inclusion Criteria for Randomized Phase:
• Women who are not postmenopausal (>/= 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug or BSC

Exclusion Criteria:

Exclusion Criteria for Enrollment Phase:
• Pregnant and lactating women
• Treatment with prior systemic chemotherapy at any time
• Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years before enrollment
• Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to enrollment
• Patients with hearing impairment
• Known sensitivity to any component of the chemotherapy regimen the patient will be assigned to, or to mannitol
• Prior treatment with an anti-PD-1, anti-PD-L1, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
• Interstitial lung disease or history of pneumonitis
• Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
• Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the MPDL3280A formulation
• History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
• Positive test for HIV
• Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C
• Active tuberculosis
• Significant cardiovascular disease, such as New York Heart Association cardiac disease(Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
• Prior allogeneic bone marrow transplantation or solid organ transplant
• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications

Specific Exclusions for Pemetrexed Treatment:
• Patients with squamous cell histology
• Patients who are receiving concurrent nonsteroidal anti-inflammatory agents (NSAIDs) and are unable to discontinue treatment

Exclusion Criteria for Randomized Phase:
• Signs or symptoms of infection within 14 days prior to randomization (severe infection within 28 days prior to randomization), including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
• Received therapeutic oral or IV antibiotics within 14 days prior to randomization
• Major surgical procedure within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study
• Administration of a live, attenuated vaccine within 28 days prior to randomization or anticipation that such a live attenuated vaccine will be required during the study
• Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to randomization
• Uncontrolled or symptomatic hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium >ULN)
• For patients who are receiving denosumab prior to randomization, unwillingness or ineligibility to receive a bisphosphonate instead while in the study

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Lung Cancer
Open to Enrollment

A Phase IIIb/IV Safety Trial of Nivolumab (BMS-936558) in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving at Least One Prior Systemic Regimen

The purpose of this study is to estimate the incidence and characterize the outcome of high grade, select adverse events in subjects with advanced or metastatic NSCLC treated with Nivolumab.

Investigator:
Dennis Lowenthal, MD
CA209-153 | PHASE III

Sponsor:
Bristol-Myers Squibb Company - CT

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

1. Target Population
•Subjects with histologically-or cytologically-documented NSCLC [squamous (SQ) or nonsquamous (NSQ)] who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiotherapy for locally advanced disease)
•Subjects must have experienced disease progression or recurrence during or after at least one systemic therapy for advanced or metastatic disease
•First line therapy is defined as therapy used to treat advanced disease. Each subsequent line of therapy is preceded by disease progression. A switch of an agent within a regimen in order to manage toxicity does not define the start of a new line of therapy
•Maintenance therapy following platinum doublet-based chemotherapy is not considered as a separate regimen of therapy
•Subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease within 6 months of completing therapy are eligible
•Subjects with recurrent disease >6 months after platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a platinum doublet-based regimen given to treat the recurrence are eligible
•Subjects with progression or recurrent disease during or after Epithelial Growth Factor Receptor (EGFR) or Anaplastic Lymphoma Kinase (ALK) tyrosine kinase inhibitor (TKI) regimen are eligible
•Experimental therapies when given as separate regimen are considered as separate line of therapy
•Eastern Cooperative Oncology Arm (ECOG) performance status (PS)
•PS 0 to 1
•PS 2

Exclusion Criteria:
1. Target Disease Exceptions
◦Subjects with active central nervous system (CNS) metastases are excluded
◦Subjects with carcinomatous meningitis

2.Medical History and Concurrent Diseases
◦Subjects with a history of interstitial lung disease
◦Subjects with active, known or suspected autoimmune disease
◦Subject whom participated in either arm of the following clinical trials CA209-017, CA209-057, CA209-026, and CA184-104 or received prior treatment with anti-programmed death 1 (PD-1) or anti-programmed death-ligand 1 (PDL1) experimental agents

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Lung Cancer
Open to Enrollment

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients...

Investigator:
Missak Haigentz, MD

that have certain genetic changes.

A151216

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Inclusion Criteria:
• PATIENT PRE-REGISTRATION ELIGIBILITY CRITERIA:
• For pre-surgical patients
◦ Suspected diagnosis of resectable non-small cell lung cancer; cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus a "nonsquamous" histology; patients with squamous cell carcinoma are eligible only if the registering site has EA5142 Institutional Review Board (IRB) approved
◦ Suspected clinical stage of IIIA, II (IIA or IIB) or large IB (defined as size >= 4cm); Note: IB tumors < 4cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4cm
• For post-surgical patients
◦ Completely resected non-small cell lung cancer with negative margins (R0); patients with squamous cell carcinoma are eligible only if the registering site has EA5142 IRB approved
◦ Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size >= 4 cm); Note: IB tumors < 4cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4cm
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• No patients who have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer
• No locally advanced or metastatic cancer requiring systemic therapy within 5 years prior to registration; no secondary primary lung cancer diagnosed concurrently or within 2 year prior to registration
• No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD-1/PD-L1/CTLA-4
• No patients known to be pregnant or lactating
• Patients who have had local genotyping are eligible, regardless of the local result
• No patients with recurrence of lung cancer after prior resection
• Note: Post-surgical patients should proceed to registration immediately following preregistration
• PATIENT REGISTRATION ELIGIBILITY CRITERIA:
• Completely resected NSCLC with negative margins (R0); cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus a "nonsquamous" histology; patients with squamous cell carcinoma are eligible only if the registering site has EA5142 IRB approved
• Pathologic stage IIIA, IIA or IIB, or large IB (defined as size >= 4cm); Note: IB tumors < 4cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4cm
• Tissue available for the required analyses (either clinical tissue block or slides and scrolls)
• In order to allow for time for central genotyping and eligibility for the ALCHEMIST treatment trial, patients must register within the following eligibility windows, depending on the adjuvant treatment approach:
◦ If no adjuvant therapy, register patient within 75 days following surgery
◦ If adjuvant chemotherapy or radiotherapy only, register patient within 225 days following surgery
◦ If adjuvant chemotherapy and radiation, register patient within 285 days following surgery

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Lung Cancer
Open to Enrollment

Adjuvant Nivolumab in Resected Lung Cancers (ANVIL)-A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-small Cell Lung Cancers

This randomized phase III trial studies how well nivolumab after surgery and chemotherapy work in treating patients with stage IB-IIIA non-small cell lung cancer. Monoclonal antibodies, such as nivolumab, may stimulate the immune system in different ways and...

Investigator:
Missak Haigentz, MD

kill tumor cells remaining after surgery and standard of care chemotherapy.

EA5142 | PHASE III

Sponsor:
Eastern Cooperative Oncology Group

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Patients must have undergone complete surgical resection of their stage IB (>= 4 cm), II or IIIA NSCLC according to the American Joint Committee on Cancer (AJCC) 7th edition and have had negative surgical margins
• Baseline chest computed tomography (CT) must be performed within 1 month (30 days) of randomization to ensure no evidence of disease; if clinically indicated, additional imaging studies must be performed to rule out metastatic disease
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization
• Non-squamous tumors must be epidermal growth factor receptor (EGFR) and anaplastic lymphoma receptor tyrosine kinase (ALK) wild-type (results ascertained in centrally as part of ALCHEMIST-SCREEN protocol)
• Tumors must have PD-L1 status tested centrally as part of the ALCHEMIST-SCREEN protocol
• Women must not be pregnant or breast-feeding
• All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse during the treatment period and for 31 weeks after the last nivolumab infusion
• Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
• No prior treatment with an immune checkpoint inhibitor (anti-programmed cell death [PD]-1, anti-PD-L1, anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA4] monoclonal antibody)
• Patients must have adequately recovered from surgery and chemotherapy at the time of randomization
◦ Minimum time between date of surgery and randomization is 4 weeks (28 days)
◦ Maximum time allowed between surgery and randomization:
◾3 months (90 days) if no chemotherapy is administered
◾8 months (240 days) if adjuvant chemotherapy was administered
◾10 months (300 days) if adjuvant chemotherapy and radiation therapy was administered
• Patients must have completed and recovered from any adjuvant chemotherapy 2 or more weeks prior to randomization (6 weeks for mitomycin and nitrosoureas; 4 weeks for post-operative radiation therapy)
• Serum aspartate transaminase (aspartate aminotransferase [AST]) and serum alanine transaminase (alanine aminotransferase [ALT]) =< 2.5 x upper limit normal
• Total bilirubin =< 1.5 x upper limit of normal (ULN) (except in subjects with Gilbert syndrome who must have a total bilirubin < 3.0 x ULN)
• White blood cell (WBC) >= 2000/uL
• Neutrophils >= 1000/uL
• Platelets >= 100 x 10^3/uL
• Hemoglobin >= 8 g/dL
• Serum creatinine =< 2 x ULN
• Prior to randomization patients with any non-hematologic toxicity from surgery, chemotherapy and radiation therapy must have recovered to grade =< 1 with the exception of alopecia, ototoxicity and neuropathy
• Patients must not be receiving any other investigational anti-cancer agents while on study
• Patients must not have known or suspected autoimmune disease; subjects with type I diabetes mellitus, hypothyroidism requiring hormone replacement, or skin disorders not requiring systemic treatment are permitted to enroll
• Patients must not have a condition requiring systemic corticosteroids equivalent to > 10 mg prednisone per day or other immunosuppressive medications within 2 weeks of randomization
• Patients must not have known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
• Patients must not have a known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection that is untreated and/or with a detectable viral load
• Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab

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Lung Cancer
Open to Enrollment

Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice

This is an observational, multicenter study in patients treated with nivolumab for the approved indications of melanoma and lung cancer in Australia, the EU, Switzerland, and the United States (US). Targeted countries in the EU for study participation include...

Investigator:
Dennis Lowenthal, MD

Austria, Belgium, France, Germany, Italy, Spain, and the United Kingdom (UK). Study objectives are to assess the safety experience, survival, adverse event management, and outcomes of adverse events associated with nivolumab in routine oncology care facilities.

CA209-234

Sponsor:
Bristol-Myers Squibb Company - CT

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample

Study Population:
The study population consists of 400 adults treated with nivolumab for histologically or cytologically confirmed melanoma and 800 adults treated with nivolumab for histologically or cytologically confirmed lung cancer in accordance with the approved indications in Australia, the EU, Switzerland, and the US. Target EU countries for patient enrollment include Austria, Belgium, France, Germany, Italy, Spain, and the UK. Patients who begin treatment with nivolumab for the first time will be enrolled in accordance with the approved indications and whose treatment strategy was determined independently from consideration of study participation. Treatment will be determined at the treating physician's discretion and with the patient's consent.

Inclusion Criteria:
• Age ≥18
• Histologically or cytologically confirmed diagnosis of melanoma (including uveal melanoma) or lung cancer
• Treatment with commercial nivolumab for the first time, alone or in combination with ipilimumab, for the approved indications of nivolumab within 14 days before informed consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy is determined before an informed consent to study participation, and treatment is initiated within 28 days after informed consent

Exclusion Criteria:
• Prior participation in a clinical trial within the past 4 weeks
• Previously treated with anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies
• Previously treated with anti-CTLA-4 for lung cancer
• Current or pending participation in a clinical trial
• Current or pending systemic treatment for cancer other than melanoma and lung cancer
• Inability to comply with the study protocol

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Lung Cancer
Open to Enrollment

Randomized Study of Erlotinib vs Observation in Patients With Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)

This randomized phase III trial studies how well erlotinib hydrochloride compared to observation works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery. Erlotinib hydrochloride may stop the growth...

Investigator:
Missak Haigentz, MD

of tumor cells by blocking some of the enzymes needed for cell growth.

A081105 | PHASE III

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Previously registered to A151216, with the result of lung cancer harboring an EGFR exon 19 deletion or L858R mutation; the testing must have been performed by one of the following criteria:
1. Patient registered to A151216 and the assessment performed centrally by the protocol-specified laboratory
2. By a local Clinical Laboratory Improvement Amendments (CLIA) certified laboratory; the report must indicate the result as well as the CLIA number of the laboratory that performed the assay; these patients will also have been registered to A151216, but can be enrolled on A081105 regardless of the central lab results
◾ Patients with known resistant mutations in the EGFR tyrosine-kinase (TK) domain (T790M) are not eligible
◾ Patients that are both EGFR mutant and anaplastic lymphoma kinase (ALK) rearrangements will be registered to A081105
• Completely resected stage IB (>= 4 cm), II or IIIA non-squamous NSCLC with negative margins; patients may not have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer
• Complete recovery from surgery and standard post-operative therapy (if required); patients must be completely recovered from surgery at the time of randomization; the minimum time requirement between date of surgery and randomization must be at least 28 days, the maximum time requirement between surgery and randomization must be 90 days if no adjuvant chemotherapy was administered, 240 days if adjuvant chemotherapy was administered, and 300 days if adjuvant chemotherapy and radiation therapy was administered
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• No locally advanced or metastatic cancer requiring systemic therapy within 5 years prior to registration; no secondary primary lung cancer diagnosed concurrently or within 2 years prior to registration
• Non-pregnant and non-lactating
• No history of cornea abnormalities
• Granulocytes >= 1,500/ul
• Platelets >= 100,000/ul
• Total bilirubin =< 1.5 x upper limit of normal (ULN)
• Serum glutamic oxaloacetic transaminase (SGOT) =< 1.5 x ULN
• Serum creatinine =< 1.5 x ULN

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Lung Cancer
Open to Enrollment

The FAMRI-IELCAP Collaborative Network to study Health Effects of Secondhand Smoke Exposure

This study explores the early detection and treatment of lung cancer and other diseases associated with secondhand smoke exposure through the use of low-dose computed tomography (CT) screening.

Investigator:
Mark Widmann, MD
FAMRI-IELCAP | PHASE NA

Sponsor:
Icahn School of Medicine at Mount Sinai

Inclusion & Exclusion Criteria:
Inclusion:
• Asymptomatic never smokers who have been exposed to secondhand smoke
• 40 years old and over

Exclusion:
• Pregnant women
• CT chest scan in the past 3 years
• Lung cancer or symptoms of lung cancer (hemoptysis, worsening cough with hoarseness, unexplained loss of weight)
• Other metastatic cancer (prophylactic treatment is acceptable)

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Lupus
Open to Enrollment

A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects With Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects With Active Cutaneous Lupus Erythematosus With or Without Systemic Manifestations

The primary objective of the study is to evaluate the efficacy of BIIB059 in reducing skin disease activity in participants with systemic lupus erythematosus (SLE) (Part A), and in participants with active cutaneous lupus erythematosus (CLE) with or without...

Investigator:
Neil Kramer, MD

systemic manifestations (Part B), and to investigate the dose response relationship in participants with active SLE and skin manifestations (Part A only). Secondary objective is to evaluate additional efficacy parameters of BIIB059 in reducing SLE disease activity.

230LE201 | PHASE II

Sponsor:
Biogen MA Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Key Inclusion Criteria:
1. All women of childbearing potential and all men must practice effective contraception during the study and for 4 months after their last dose of study treatment.
2. CLASI-A ≥ 8 at Screening and Randomization.

Key Exclusion Criteria:
1. Active lupus nephritis or moderate-to-severe or chronic kidney disease.
2. Any active skin conditions other than CLE that may interfere with the study (e.g., psoriasis, non-LE skin lupus, drug-induced lupus).
3. History of chronic, recurrent, or recent serious infection.
4. Active clinically significant viral, bacterial, or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks of or during Screening, or completion of oral anti-infectives within 2 weeks before or during Screening.
5. Use of immunosuppressive or disease-modifying treatments for SLE that were initiated less than 3 months prior to Screening.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

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Lupus
Open to Enrollment

A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Effect of BI 655064 Administered as Sub-cutaneous Injections, on Renal Response After One Year Treatment in Patients With Lupus Nephritis

The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within...

Investigator:
Neil Kramer, MD

the therapeutic range, and select the target dose for phase III development.

1293.10 | PHASE II

Sponsor:
Boehringer Ingelheim Pharmaceuticals Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion criteria:
• Males and females 18-70 years. Women of childbearing potential must be ready and able to use highly effective methods of birth control per international Conference on Harmonisation M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
• Diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology criteria 1997, at least 4 criteria must be documented, one of which must be a positive anti-dsDNA antibody
• Lupus Nephritis Class III or IV (International Society of Nephrology (ISN)/Renal Pathology Society (RPS) -2003 classification) with either active or active/chronic disease, co-existing class V permitted, proven by renal biopsy within 3 months prior to screening or during screening if induction therapy has not yet been started
• Active renal disease evidenced by proteinuria >= 1.0 g/day (Uprot/Ucrea >= 100 mg/mmol)
• Signed and dated written informed consent

Exclusion criteria:
• Clinically significant current other renal disease
• Glomerular Filtration Rate <30ml/min/1.73m²
• Acute presence of Oliguria (<500 mL/day)
• Dialysis within 12m of screening
• Antiphospholipid syndrome
• Diabetes mellitus poorly controlled or known diabetic retinopathy or nephropathy
• Evidence of current or previous clinically significant disease, medical condition or finding in the medical examination that in the investigator's opinion would compromise the safety of the patient or the quality of the data
• Any induction therapy for Lupus Nephritis within the last 6 months prior to randomisation except induction with Mycophenolate Mofetil and high dose steroids started within 4 weeks prior to randomisation
• Treatment with any biologic B-cell depleting therapy (e.g. anti-CD20, anti-CD22, anti-BLyS) within 12 months prior to randomisation
• Treatment with abatacept within 12 months prior to randomisation
• Treatment with tacrolimus or cyclosporin within 4 weeks prior to randomisation
• Treatment with cyclophosphamid within 6 months prior to randomisation
• Treatment with investigational drug within 6 months or 5 half-lives, whichever is greater before randomisation
• Contraindication for MMF or corticosteroids
• Chronic or relevant acute infections, including but not limited to HIV, Hepatitis B and C and tuberculosis (including a history of clinical tuberculosis (TB) and/or a positive QuantiFERON TB-Gold test
• Any active or suspected malignancy or history of documented malignancy within the last 5 years before screening, except appropriately treated carcinoma in situ and treated basal cell carcinoma.
• Live vaccination within 6 weeks before randomisation
• Patients unable to comply with the protocol in the investigator's opinion.
• Alcohol abuse in the opinion of the investigator or active drug abuse .
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial
• Impaired hepatic function, defined as serum Aspartate Transferase/Alanine Transferase, bilirubin or alkaline phosphatase levels > 2 x Upper Limit of Normal

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Mitral Valve
Open to Enrollment

Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients (The COAPT Trial)

The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation(COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of...

Investigator:
Robert Kipperman, MD

moderate-to-severe or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects.

COAPT

Sponsor:
Evalve, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days prior to subject registration, with MR severity based principally on the TTE study, and must be confirmed by the Echocardiography Core Lab (ECL). The ECL may request a transesophageal echocardiogram (TEE) to confirm MR etiology.
Note: Functional MR requires the presence of global or regional left ventricular wall motion abnormalities, which are believed to be the primary cause of the MR. If a flail leaflet or other evidence of degenerative MR is present, the subject is not eligible even if global or regional left ventricular systolic dysfunction is present.
Note: Qualifying TTE must be obtained after the subject has been stabilized on optimal therapy and at least 30 days after:
a.any change in guideline-directed medical therapy
b.revascularization and/or implant of Cardiac Resynchronization Therapy device (CRT or CRT-D) or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from <92% to ≥92%)

2. In the judgment of the HF specialist investigator at the site, the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure (e.g., with cardiac resynchronization therapy, revascularization, and/or optimal medical therapy as appropriate. The Eligibility Committee must also concur that the subject has been adequately treated.
3. New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
4.The Local Site Heart Team (CT surgeon and HF specialist investigators) and the Central Eligibility Committee concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy for the subject, even if the subject is randomized to the Control group.
5.The subject has had at least one hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected brain natriuretic peptide (BNP) ≥300 pg/ml or corrected n-Terminal pro- brain natriuretic peptide NT-proBNP ≥1500 pg/ml measured within 90 days prior to subject registration ("corrected" refers to a 4% reduction in the BNP or NT-proBNP cutoff for every increase of 1 kg/m2 in BMI above a reference BMI of 20 kg/m2).
Note: BNP or NT-proBNP must be obtained after the subject has been stabilized on optimal therapy and at least 30 days after:
a. any change in guideline-directed medical therapy
b. revascularization and/or implant of Cardiac Resynchronization Therapy device (CRT or CRT-D) or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from <92% to ≥92%).
6. Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50% within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI).
7.The primary regurgitant jet is non-commissural, and in the opinion of the MitraClip implanting investigator can be successfully be treated by the MitraClip. If a secondary jet exists, it must be considered clinically insignificant.
8. Creatine Kinase-MB (CK-MB) obtained within prior 14 days < local laboratory Upper Limit of Normal (ULN).
9. Transseptal catheterization and femoral vein access is determined to be feasible by the MitraClip implanting investigator.
10. Age 18 years or older.
11. The subject or the subject's legal representative understands and agrees that should he/she be assigned to the Control group, he/she will be treated with medical therapy and conservative management without surgery and without the MitraClip, either domestically or abroad. If the subject would actively contemplate surgery and/or MitraClip if randomized to Control, he/she should not be registered in this trial.
12. The subject or the subject's legal representative has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent.

Exclusion Criteria:
1. Untreated clinically significant coronary artery disease requiring revascularization.
2. Coronary artery bypass grafting (CABG) within 30 days prior to subject registration.
3. Percutaneous coronary intervention within 30 days prior to subject registration.
4. Tricuspid valve disease requiring surgery.
5. Aortic valve disease requiring surgery.
6. Cerebrovascular accident within 30 days prior to subject registration.
7. Severe symptomatic carotid stenosis (> 70% by ultrasound).
8. Carotid surgery within 30 days prior to subject registration.
9. American College of Cardiology /American Heart Association (ACC/AHA) Stage D heart failure.
10. Presence of any of the following:
◦Estimated pulmonary artery systolic pressure (PASP) > 70 mm Hg assessed by site based on echocardiography or right heart catheterization, unless active vasodilator therapy in the cath lab is able to reduce the pulmonary vascular resistance (PVR) to < 3 Wood Units or between 3 and 4.5 Wood Units with v wave less than twice the mean of the pulmonary capillary wedge pressure
◦Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non ischemic etiology
◦Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)
◦Hemodynamic instability requiring inotropic support or mechanical heart assistance.

11. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction.
12. Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within the last 30days prior to subject registration.
13. Mitral valve orifice area < 4.0 cm2 assessed by site based on a transthoracic echocardiogram (TTE) within 90 days prior to subject registration.
14. Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip. This evaluation is based on transesophageal echocardiogram (TEE) evaluation of the mitral valve within 180 days prior to subject registration and includes:
◦Insufficient mobile leaflet available for grasping with the MitraClip device
◦Evidence of calcification in the grasping area
◦Presence of a significant cleft in the grasping area
◦Lack of both primary and secondary chordal support in the grasping area
◦Leaflet mobility length < 1 cm

15. Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
16. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
17. Life expectancy < 12 months due to non-cardiac conditions.
18. Modified Rankin Scale ≥ 4 disability.
19. Status 1 heart transplant or prior orthotopic heart transplantation.
20. Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure.
21. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
22. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated).
23. Active infections requiring current antibiotic therapy.
24. Subjects in whom transesophageal echocardiography (TEE) is contraindicated or high risk.
25. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.
26. Pregnant or planning pregnancy within next 12 months.
Note: Female patients of childbearing age should be instructed to use safe contraception (e.g. intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release. It is accepted in certain cases to include subjects having a sterilized regular partner or subjects using a double barrier contraceptive method. However, this should be explicitly justified in special circumstances arising from the study design, product characteristics and/or study population.

27. Currently participating in an investigational drug or another device study that has not reached its primary endpoint. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
28. Subject belongs to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures.

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Mitral Valve
Open to Enrollment

Prospective Evaluation of MRI as a Predictor of Outcomes in Patients Undergoing Mitral Valve Surgery: MRI-MVS Study

In a recent study, quantification of mitral regurgitant volume MRI was found to be more accurate than echocardiography in patients who underwent mitral valve surgery. All 38 patients who underwent mitral valve surgery in this study were deemed appropriate...

Investigator:
Seth Uretsky, MD

according the ACC/AHA guidelines based on echocardiographic findings. However, more than 2/3rds of patients who underwent mitral valve surgery in this study did not have severe MR by MRI. Thus, we propose this prospective multicenter trial to assess: 1) the severity of MR by MRI in patients undergoing mitral valve surgery. 2) the impact of mitral valve surgery on quality of life and healthcare costs in the context of MR severity by MRI, 3) assess patient outcomes post surgery in the context of MR severity by MRI and 4) the likelihood of valve replacement vs. repair according to MR severity by MRI.

MRI-MVS

Sponsor:
Atlantic Health System

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population:
Subjects who are scheduled to undergo ACC/AHA guideline directed mitral valve surgery for mitral regurgitation.

Inclusion Criteria:
• Age 18 years and older.
• Able to give informed consent.
• Undergoing lone mitral valve surgery for chronic primary mitral regurgitation within 30 days.
• Indication for mitral valve surgery is a class I or IIa according to the 2014 ACC/AHA guidelines for the management of valvular heart disease.

Exclusion Criteria:
• Secondary mitral regurgitation.
• Have a device which is not compatible with MRI
• Claustrophobia preventing MRI.
• Concomitant CABG, other valve surgery, or other cardiac surgery.
• Atrial fibrillation or other substantial arrhythmia that would substantially degrade MRI image acquisition.

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Multiple Myeloma
Completed

Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma

This randomized phase II/III trial studies how well lenalidomide works and compares it to observation in treating patients with asymptomatic high-risk asymptomatic (smoldering) multiple myeloma. Biological therapies such as lenalidomide, may stimulate the...

Investigator:
Neil Morganstein, MD

immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether lenalidomide is effective in treating patients with high-risk smoldering multiple myeloma than observation alone.

E3A06 | PHASE II/III

Sponsor:
Eastern Cooperative Oncology Group

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:

- Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 60 months, as confirmed by both of the following:
- Bone marrow plasmacytosis with >= 10% plasma cells or sheets of plasma cells at any time before initiating study treatment, including a marrow which must be obtained by bone marrow aspiration and/or biopsy within 4 weeks prior to randomization
- Abnormal serum free light chain ratio (< 0.26 or > 1.65) by serum free light chain (FLC) assay; FLC assay must be performed within 28 days of randomization
- Patients must have measurable levels of monoclonal protein (M-protein): >= 1g/dL on serum protein electrophoresis or >= 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis which must be obtained within 4 weeks prior to randomization
- Patients must have no lytic lesions on skeletal surveys and no hypercalcemia (i.e., >= 11 mg/dL)
- Hemoglobin >= 11 g/dL
- Platelet count >= 100,000/mm^3
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Calculated creatinine clearance >= 30 mL/min
- Bilirubin =< 1.5 mg/dL
- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and serum glutamic oxaloacetic transaminase (SGPT) (aspartate aminotransferase [AST]) =< 2.5 times upper limit of normal
- No prior or concurrent systemic or radiation therapy for the treatment of myeloma
- Concurrent use of bisphosphonates is not permitted; however, prior bisphosphonates or once-a-year intravenous bisphosphonate given for the treatment of osteoporosis is permitted
- Prior or concurrent use of erythropoietin is disallowed
- Prior glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted
- Prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day
- Prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted
- Patients must not have active, uncontrolled seizure disorder; patients must have had no seizures in the last 6 months
- Patients must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson Syndrome
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Patients must not have baseline bone lesions or plasmacytomas
- Patients with monoclonal gammopathy of undetermined significance are not eligible
- Patients must not have grade 2 or higher peripheral neuropathy
- Patients must not have active, uncontrolled infection
- Patients may have a history of current or previous deep vein thrombosis or pulmonary embolism but are required to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation
- Patients should not have New York Heart Association classification III or IV heart failure
- Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for cure of the specific cancer; for most diseases this time frame is 5 years
- Patients should not be felt to have an immediate need for chemotherapy
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting cycle 1 of lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure

-Human immunodeficiency virus (HIV) infection is not excluded; HIV+ patients must meet the following criteria:
Cluster of differentiation (CD)4 cell count >= 350/mm^3
No history of acquired immune deficiency syndrome (AIDS)-related illness
Not currently prescribed zidovudine or stavudine

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Neonatology
Completed

A Multicenter, Randomized, Open-Label, Controlled Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Preterm Neonates

The primary objective of this study is to evaluate the safety and tolerability of a single exposure of aerosolized surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses to preterm neonates 29 to 34 weeks gestational...

Investigator:
John Ladino, MD

age who are receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS), compared to neonates receiving nCPAP alone.

03-CL-1201 | PHASE II

Sponsor:
Discovery Laboratories, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: up to 21 Hours
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
•Informed consent from a legally authorized representative
•Gestational age 29 to 34 completed weeks (34 weeks 6 days) post menstrual age (PMA)
•Successful implementation of controlled nCPAP within 60 minutes after birth
•Spontaneous breathing
•Chest radiograph consistent with RDS
•Need for moderate levels of supplemental oxygen and nCPAP to maintain oxygen saturation of 88% to 95% for at least 60 minutes within the first 21 hours after birth

Exclusion Criteria:
•Heart rate that cannot be stabilized above 100 beats/minute within 5 minutes of birth
•Recurrent episodes of apnea occurring after the initial newborn resuscitation period (ie, 10 minutes after birth) requiring intermittent positive pressure breaths using inflating pressures above the set CPAP pressure administered manually or mechanically through any patient interface
•A 5 minute Apgar score < 5
•Major congenital malformation(s) and cranial/facial abnormalities that preclude nCPAP, diagnosed antenatally or immediately after birth
•Other diseases or conditions potentially interfering with cardiopulmonary function (eg, hydrops fetalis or congenital infection such as TORCH)
•Known or suspected chromosomal abnormality or syndrome
•Prolong rupture of membranes (PROM) > 2 weeks
•Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic support
•Need for endotracheal intubation and mechanical ventilation
•Has been administered: another investigational agent or exposure to a medical device, any other surfactant agent, steroid treatment after birth

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Ovarian Cancer
Open to Enrollment

A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Women With Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received at Least Three Previous Chemotherapy Regimens

This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received at least three previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered...

Investigator:
Nana Tchabo, MD

once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.

PR-30-5020-C | PHASE II

Sponsor:
Tesaro Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:

- Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed
- Histologically diagnosed recurrent high-grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
- Must have completed at least 3 previous chemotherapy regimens
- ECOG 0-1
- Adequate bone marrow, kidney and liver function

Exclusion Criteria:

- Known hypersensitivity to the components of niraparib
- Symptomatic uncontrolled brain metastasis
- Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
- Is pregnant or breast feeding
- Immunocompromised patients
- Known active hepatic disease

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Ovarian Cancer
Open to Enrollment

A phase 3 randomized double-blind trial of maintenance with Niraparib versus placebo in patients with Platinum Sensitive Ovarian Cancer

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their...

Investigator:
Nana Tchabo, MD

most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.

PR-30-5011-C | PHASE III

Sponsor:
Tesaro Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:
•18 years of age or older, female, any race
•Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer
•High grade (or grade 3) serous histology or known to have gBRCAmut
•Has received at least 2 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than 6 month period between penultimate platinum regimen and progression of disease)
•Has response to last the platinum regimen, remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen
•ECOG 0-1
•Adequate bone marrow, kidney and liver function

Exclusion Criteria:
•Known hypersensitivity to the components of niraparib
•Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
•Symptomatic uncontrolled brain metastasis
•Is pregnant or breast feeding
•Immunocompromised patients
•Known active hepatic disease
•Prior treatment with a known PARP inhibitor

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Ovarian Cancer
Open to Enrollment

A Randomized, Open-Label Study Comparing the Combination of YONDELIS and DOXIL/CAELYX With DOXIL/CAELYX Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

The purpose of this study is to assess the efficacy and safety of trabectedin+DOXIL as a third-line chemotherapy regimen (treatment) in patients with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who...

Investigator:
Paul Heller, MD

received 2 previous lines of platinum-based chemotherapy.

ET743-OVC-3006 | PHASE III

Sponsor:
Janssen R & D

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:
•Histologically proven advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer
•Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
•Received first-line treatment with a platinum-based regimen and had no evidence of disease progression for 6 months after the last dose
•Received second-line treatment with a platinum-based regimen, with progression of disease after attaining a complete response (CR) or partial response (PR)
•Progression of disease based on imaging after the second-line platinum-based regimen (individuals treated with a pegylated liposomal doxorubicin-containing regimen as a second-line therapy are eligible if subsequent disease progression occurs >=9 months from the first dose)
•Evidence of measurable disease at screening as evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
•Able to receive intravenous (IV) dexamethasone or an equivalent IV corticosteroid
•Have a known BRCA 1/2 mutation status (for participants who do not have a known BRCA 1/2 status at screening, a blood sample will be collected to determine the status with the results available prior to randomization
•Laboratory values within protocol -defined parameters
•Have left ventricular ejection fraction by multigated acquisition scan (MUGA) scan or 2D-ECHO within normal limits for the institution
•Have side effects (except alopecia) of prior treatment resolved to at least Grade 1 according to the National Cancer Institute - Common Terminology Criteria of Adverse Events (NCICTCAE) (Version 4.0)
•Have a negative urine or serum pregnancy test at screening
•Agrees to protocol-defined use of effective contraception

Exclusion Criteria:
•Diagnosis of ovarian carcinoma with mucinous histology
•Had more than 2 prior lines of chemotherapy
•Prior exposure to trabectedin or hypersensitivity to any of the excipients
•Prior treatment with doxorubicin or other anthracycline at cumulative doses greater than 300 mg/m2 (calculated using doxorubicin equivalent doses: 1 mg doxorubicin = 1 mg Doxil/Caelyx = 1.8 mg epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin)
•Unwilling or unable to have a central venous catheter placed
•Pregnant or breast-feeding
•Less than 3 weeks from radiation therapy, experimental therapy, hormonal therapy, prior chemotherapy, or biological therapy
•History of another neoplastic disease (except non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ adequately treated) unless in remission for 5 years
•Known allergies, hypersensitivity, or intolerance to Doxil, dexamethasone, or their excipients
•Known history of central nervous system metastasis
•Known significant chronic liver disease, such as cirrhosis or active hepatitis (potential participants who test positive for hepatitis B surface antigen or hepatitis C antibodies are allowed provided they do not have active disease requiring antiviral therapy)
•Had a myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
•Has any of the following medical conditions: uncontrolled diabetes, psychiatric disorder (including dementia) that prevents compliance with protocol, uncontrolled seizures, newly diagnosed deep vein thrombosis, active systemic infection that is likely to interfere with study procedure or results
•Has any condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements

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Ovarian Cancer
Open to Enrollment

FORWARD I: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of IMGN853 to that of selected single-agent chemotherapy (Investigator's choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal...

Investigator:
Nana Tchabo, MD

cancer and/or fallopian tube cancer.

IMGN853-0403 | PHASE II

Sponsor:
ImmunoGen, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Diagnosed with advanced epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer
• Folate receptor alpha positive tumor expression as defined in the protocol
• Patients must have platinum-resistant ovarian cancer, defined as progression within 6 months from completion of a minimum of four cycles of platinum-containing therapy.
• Patients must have received at least one but no more than three prior systemic treatment regimens and for whom single-agent chemotherapy is appropriate as the next line of treatment
• Patients must have at least one lesion that meets the definition of measurable disease by RECIST 1.1

Exclusion Criteria:
• Diagnosis of clear cell or low grade ovarian cancer
• Patients with primary platinum-refractory disease
• Serious concurrent illness or clinically relevant active infection as defined in the protocol
• Prior treatment with IMGN853
• Women who are pregnant or breast feeding

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Ovarian Cancer
Open to Enrollment

Non-Randomized, Open-Label Phase II Study to Assess Olaparib Tablets as a Treatment for Subjects With Different HRD Tumor Status and With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer That Have Received at Least 2 Prior Lines of Chemotherapy

This is a non-randomized, open-label study to assess olaparib tablets as a treatment for subjects with different homologous recombination deficiency (HRD) tumor status and with platinum-sensitive, relapsed, high-grade ovarian cancer. Subjects should have received...

Investigator:
Nana Tchabo, MD

at least 2 prior lines of platinum-based chemotherapy.

D0816L00003 | PHASE II

Sponsor:
AstraZeneca

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 130 Years (Adult, Senior)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Provision of written signed informed consent prior to any study specific procedures;
• Female subjects with histologically diagnosed relapsed high-grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer);
• At least 1 lesion (measurable by RECIST v1.1) that can be accurately assessed at baseline by computed tomography (CT)/magnetic resonance imaging (MRI) and is suitable for repeated assessment;
• Subjects must have received at least 2 prior platinum-based lines of chemotherapy for ovarian cancer. Note: There is no limit on the number of non-platinum-based lines of chemotherapy;
• Subjects must be partially-platinum-sensitive (defined as progression 6 to 12 months after the end of the last platinum-based chemotherapy) or platinum sensitive (defined as progression > 12 months after the end of the last platinum-based chemotherapy);
• Subjects must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment;
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 (see Appendix F);
• Subjects must have a life expectancy greater than or equal to 16 weeks;
• Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on Day 1;
• Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations; and
• Formalin fixed, paraffin embedded tumor sample (either archival or fresh sample) from the primary or recurrent cancer must be available for central testing. If there is not written confirmation of the availability of an archived or fresh tumor sample prior to enrollment, the subject is not eligible for the study.

Exclusion Criteria:
• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca Representative staff and/or staff at the study site);
• Previous enrollment in the present study;
• Exposure to any investigational product (IP) within 30 days or 5 half-lives (whichever is longer) prior to start of study treatment;
• Any previous treatment with a PARP inhibitor, including olaparib;
• Subjects who have platinum-resistant or refractory disease defined as progression during or within 6 months of the last platinum-based chemotherapy;
• Other malignancy within the last 5 years (few exceptions apply);
• Resting ECG with clinically significant abnormal findings;
• Subjects receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment;
• Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors;
• Concomitant use of known strong or moderate CYP3A inducers;
• Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade 2) caused by previous cancer therapy, excluding alopecia;
• Subjects with MDS/AML or with features suggestive of MDS/AML;
• Subjects with pneumonitis or at risk of pneumonitis;
• Subjects with symptomatic uncontrolled brain metastases;
• Major surgery within 2 weeks of starting study treatment, and subjects must have recovered from any effects of any major surgery;
• Subjects considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection;
• Breast feeding women;
• Immunocompromised subjects, e.g., subjects who are known to be serologically positive for human immunodeficiency virus;
• Subjects with known active hepatitis (i.e., Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids

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Ovarian Cancer
Open to Enrollment

Phase 1/2 Clinical Study of Niraparib in Combination With Pembrolizumab in Patients With Advanced or Metastatic Triple-Negative Breast Cancer and in Patients With Recurrent Ovarian Cancer

This Phase 1/2 study will evaluate the safety and efficacy of combination treatment with niraparib and pembrolizumab (MK-3475) in patients with advanced or metastatic triple-negative breast cancer or recurrent ovarian cancer. (KEYNOTE-162)

Investigator:
Nana Tchabo, MD
3000-PN162-01-001 | PHASE I/II

Sponsor:
Tesaro Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Main Inclusion Criteria:
• Histologically proven advanced (unresectable) or metastatic cancer as outlined below
a.Patients with triple-negative breast cancer (TNBC) who have been treated with at least 1 prior regimen for advanced/metastatic disease or who relapsed/progressed while on or within 1 month from completion of adjuvant chemotherapy
Phase 1: Up to 3 lines of prior chemotherapy are allowed
Phase 2: Up to 2 lines of prior chemotherapy are allowed
b.Patients with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer who have recurrent disease and have been previously treated with chemotherapy for advanced/metastatic disease and who experienced a response lasting at least 6 months to first-line platinum-based therapy but currently considered platinum-resistant
Phase 1: Up to 4 lines of prior chemotherapy are allowed
Phase 2: Up to 3 lines of prior chemotherapy are allowed
• Archival tumor tissue available or a fresh biopsy must be obtained prior to study treatment initiation
• Measurable lesions by RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) 0 or 1
• Adequate organ function
• Able to take oral medications
• Female patient, if of childbearing potential, has a negative serum pregnancy test within 72 hours of taking study medication and agrees to abstain from activities that could result in pregnancy from enrollment through 120 days after the last dose of study treatment
• Male patient agrees to use an adequate method of contraception

Main Exclusion Criteria:
• Progressed while on platinum treatment or within 1 month from completion of platinum-containing regimen in any line of therapy
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis Note: Patients previously treated for brain metastases may be able to participate provided they are stable
• Patient has a known additional malignancy that progressed or required active treatment within the last 5 years (exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer)
• Poor medical risk
• Pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study
• Immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
• Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
• Known active hepatitis B or hepatitis C
• Active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
• History of interstitial lung disease
• Known history of platelet transfusion for chemotherapy-induced thrombocytopenia or persistent (> 4 weeks) ≥ Grade 3 hematological toxicity or fatigue from prior cancer therapy
• Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2
• Prior treatment with a known poly(ADP-ribose) polymerase (PARP) inhibitor
• Heart-rate corrected QT interval (QTc) prolongation > 470 msec at screening
• Known history of myelodysplastic syndrome (MDS) or a pre-treatment cytogenetic testing result at risk for a diagnosis of MDS/acute myeloid leukemia (AML)
• Receiving concomitant medications that prolong QTc and is unable to discontinue use

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Ovarian Cancer
Open to Enrollment

Use of the CA125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women

The goal of this clinical research study is to evaluate a method involving a blood test, called CA-125, that may be helpful in the early detection of ovarian cancer in post-menopausal women.

Investigator:
Daniel Tobias, MD
ID01-022

Sponsor:
University of Texas M.D. Anderson Cancer Center

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 50 Years to 74 Years
Genders Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Sampling Method: Non-Probability Sample

Study Population: Study participants considered to be at low risk for ovarian cancer.

Inclusion Criteria:
1.Female, >/= 50 years old or less than 75 years old
2.Postmenopausal (>/= 12 months amenorrhea)
3.Have at least one ovary
4.Cancer-free and have not received any chemotherapy or radiation therapy for >/=12 months prior to enrolling on this study
a. Women who have a history of non-ovarian malignancy will be eligible if they have no persistent or recurrent disease and have not received treatment for >12 months.
b. If they are on SERM (i.e. tamoxifen or aromatase inhibitors) they will not be excluded.
c. Women maybe undergoing or have had treatment <12 months prior to study entry for basal cell carcinoma only.
5.Willingness to return to an Atlantic Health System medical center for CA 125 blood tests annually or earlier if indicated
6.Willingness to return to an Atlantic Health System medical center to undergo transvaginal ultrasound if indicated.
7.Women need to provide the name of a gynecologist or qualified healthcare professional willing to provide appropriate follow-up care if indicated

Exclusion Criteria:
1.Female: Less than 50 years old or older than 75 years
2.Psychiatric or psychological or other conditions which prevent a fully informed consent.
3.Prior removal of both ovaries.
4.Active non-ovarian malignancy.
5. High risk for ovarian cancer: These conditions can also be met using the participant and one 1st or 2nd degree female relative.
a. Known mutation in BRCA1 or BRCA2
b. Two 1st or 2nd degree relatives of same lineage who have: two ovarian cancers; one ovarian cancer and one pre-menopausal breast cancer; two pre-menopausal breast cancers; one pre-menopausal and one post-menopausal breast cancer.
c. Ashkenazi Jewish descent: one 1st degree or two 2nd degree relatives with pre-menopausal breast or ovarian cancer; or participant has had pre-menopausal breast cancer.
6. 1st or 2nd degree male relative with breast cancer diagnosed at any age.
7. HNPCC/Lynch Syndrome: known genetic mutation, presumed HNPCC carrier, Amsterdam criteria.

First degree relative defined as: children, siblings and parents. Second degree relative defined as: half-siblings, aunts, uncles, nieces, nephews, grandparents, and grandchildren.

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Ovarian Cancer,
Open to Enrollment

Phase 2, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Niraparib Combined With Bevacizumab as Maintenance Treatment in Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Following Front-line Platinum-based Chemotherapy With Bevacizumab

This is a Phase 2, open-label, single arm study to evaluate progression free survival rate at 18 months as well as evaluating the safety and efficacy of niraparib in combination with bevacizumab as maintenance therapy in patients with advanced ovarian cancer...

Investigator:
Nana Tchabo, MD

patients who have received prior front-line therapy with platinum-based chemotherapy in combination with bevacizumab and who have had at least one prior attempt at debulking surgery.

3000-02-004 | PHASE II

Sponsor:
Tesaro Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Patients must be female, be ≥ 18 years of age, be able to understand the study procedures, and agree to participate in the study by providing written informed consent.
2. Patients must have newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB to IV epithelial ovarian, fallopian tube, or peritoneal cancer and have recovered from debulking surgery.
3. Patients must have high-grade serous or endometrioid or high-grade predominantly serous or endometrioid histology, regardless of HRD or germline breast cancer susceptibility gene (gBRCA) mutation status. Patients with non mucinous epithelial ovarian cancer and gBRCA mutation are eligible.
4. Patients must have completed front-line, platinum-based chemotherapy with CR, PR, or NED and have first study treatment dose within 12 weeks of the first day of the last cycle of chemotherapy:
1. A platinum-based regimen must have consisted of a minimum of 6 and a maximum of 9 treatment cycles. Patients who discontinued platinum-based therapy early as a result of non hematologic toxicity specifically related to the platinum regimen (ie, neurotoxicity or hypersensitivity) are eligible if they have received a minimum of 4 cycles of the platinum regimen.
2. IV, intraperitoneal, or neoadjuvant platinum-based chemotherapy is allowed; for weekly therapy, 3 weeks is considered 1 cycle. Interval debulking is allowed.
5. Patients must have received, prior to enrollment, a minimum of 3 cycles of bevacizumab in combination with the last 3 cycles of platinum-based chemotherapy. Patients who undergo interval debulking surgery are eligible if they have received only 2 cycles of bevacizumab in combination with the last 3 cycles of platinum-based chemotherapy.
6. Patients must have had 1 attempt at optimal debulking surgery.
7. Patients must have either CA-125 in the normal range or CA-125 decrease by more than 90% during front-line therapy that is stable for at least 7 days (ie, no increase > 15% from nadir).
8. Patients must have adequate organ function, defined as (Note: Complete Blood Count (CBC) test should be obtained without transfusion or receipt of stimulating factors within 2 weeks before obtaining screening blood sample):
1. Absolute neutrophil count (ANC) ≥ 1,500/µL
2. Platelet count ≥ 100,000/µL
3. Hemoglobin ≥ 9 g/dL
4. Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min using Cockcroft-Gault equation
5. Total bilirubin ≤ 1.5 × ULN OR direct bilirubin ≤ 1 × ULN
6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN unless liver metastases are present, in which case they must be ≤ 5 × ULN
9. Patients must have an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
10. Patients must have normal blood pressure or well-controlled hypertension.
11. Patient must agree to complete PROs (quality of life [QoL] questionnaire) throughout the study, including after study treatment discontinuation.
12. Patients must be able to take oral medication.
13. Patient must agree to undergo tumor HRD testing at screening. The tumor sample must be submitted for HRD testing during the Screening Period. Patients do not have to wait for the HRD test result to be enrolled. If archival tumor tissue is not available for testing, the patient must agree to undergo a fresh biopsy.
14. Patients of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin) within 72 hours prior to receiving the first dose of study treatment.
15. Patients must be postmenopausal, free from menses for > 1 year, surgically sterilized, or willing to use adequate contraception to prevent pregnancy or must agree to abstain from activities that could result in pregnancy throughout the study, starting with enrollment through180 days after the last dose of study treatment.

Exclusion Criteria:
1. Patients with ovarian tumors of non-epithelial origin (eg, germ cell tumor) or any low grade tumors.
2. Patients with clinically significant cardiovascular disease (eg, significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, cardiac arrhythmia or unstable angina < 6 months to enrollment, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, Grade II or greater peripheral vascular disease, and history of cerebrovascular accident (CVA) within 6 months).
3. Patients with gastrointestinal disorders or abnormalities that would interfere with absorption of study treatment.
4. History of bowel obstruction, including sub-occlusive disease, related to the underlying disease or history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscesses. Evidence of rectosigmoid involvement by pelvic examination or bowel involvement on computed tomography (CT) scan or clinical symptoms of bowel obstruction.
5. Patient has proteinuria as demonstrated by urine protein:creatinine ratio ≥ 1.0 at screening or urine dipstick for proteinuria ≥ 2 (patients discovered to have ≥ 2 proteinuria on dipstick at baseline should undergo a 24-hour urine collection and must demonstrate < 2 g of protein in 24 hours to be eligible).
6. Patient has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML).
7. Patient has received treatment previously with a PARP inhibitor.
8. Other than ovarian cancer, the patient has been diagnosed or treated for invasive cancer less than 5 years prior to study enrollment. Patients with cervical carcinoma in situ, non melanomatous skin cancer, and ductal carcinoma in situ definitively treated are allowed.
9. Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, non malignant systemic disease, or active, uncontrolled infection.
10. Patient has known contraindication to PARP inhibitors or vascular endothelial growth factor (VEGF) inhibitors.
11. Patient is at increased bleeding risk due to concurrent conditions (eg, major injuries or surgery within the past 28 days prior to start of study treatment, history of CVA, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months).
12. Patient is immunocompromised (patients with splenectomy are allowed).
13. Patient has known, active hepatic disease (ie, hepatitis B or C).
14. Patient has a QT interval prolongation > 480 ms at screening. If a patient has a prolonged QT interval and the prolongation is deemed to be due to a pacemaker upon Investigator evaluation (ie, the patient otherwise has no cardiac abnormalities), then the patient may be eligible to participate in the study following discussion with the Medical Monitor.
15. Patient is pregnant, breastfeeding, or expecting to conceive children while receiving study drug or for 180 days after the last dose of study drug.

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Pancreatic Cancer
Open to Enrollment

A Phase 2 Study of BPM31510 (Ubidecarenone, USP) Nanosuspension Injection Administered Intravenously With or Without Gemcitabine as 2nd/3rdline Therapy in Advanced Pancreatic Cancer Patients

This is a Phase 2 multicenter, open-label, non-randomized study to examine the safety and effectiveness of BPM31510 administered as a 144-hour continuous intravenous (IV) infusion as a monotherapy or in combination with gemcitabine in advanced pancreatic cancer...

Investigator:
Angela Alistar, MD

patients as 2nd / 3rd line therapy. The study will enroll up to 50 patients in the US and Europe.

BPM31510IV-05 | PHASE II

Sponsor:
Berg LLC

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• The patient has a histologically or cytologically confirmed metastatic pancreatic adenocarcinoma.
• The patient has undergone;
◦ at least one prior, but no more than 2 prior standard, non-gemcitabine, therapies for pancreatic cancer (for enrollment into the combination therapy arm); or,
◦ at least one prior, but no more than 2 prior standard, gemcitabine, therapies as monotherapy or as part of combination chemotherapy for pancreatic cancer (for enrollment into the monotherapy arm).
• The patient is at least 18 years old.
• The patient has an Eastern Cooperative Oncology Group (ECOG) performance status
• Measurable tumor lesions according to RECIST 1.1 criteria (Section 10.2).
• In the opinion of the Investigator, the patient has a life expectancy of > 3 months.
• Sexually active patients and their partners agree to use an accepted method of contraception during the course of the study (Appendix C:Guidelines Regarding Women of Childbearing Potential).
• Female patients of childbearing potential must have a negative pregnancy test within 1 week prior to beginning study treatment.
• The patient has adequate organ and marrow function as follows:
◦ absolute Neutrophil Count (ANC) ≥ 1500 mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL,
◦ serum creatinine < upper limit of normal (ULN);
◦ total bilirubin < 1.5 X (ULN) ; alanine aminotransferase (ALT), aspartate transaminase (AST) ≤ 2.5 times the upper limit of normal (ULN) if no liver involvement or ≤ 5 times the upper limit of normal with liver involvement.
• The patient has serum electrolytes (including calcium, magnesium, phosphorous, sodium and potassium) within normal limits (supplementation to maintain normal electrolytes is allowed).
• The patient has adequate coagulation: prothrombin time (PT) and an International Normalized Ratio (INR), and partial thromboplastin time (PTT) ≤ 1.5 times the upper limit of normal (ULN),
• In the opinion of the Investigator, the patient is capable of understanding and complying with the protocol and has signed the informed consent document.

Exclusion Criteria:
• The patient has uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure (NYHA class III and IV), uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• The patient has active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, unstable angina pectoris, or uncontrolled congestive heart failure (NYHA class III and IV).
• The patient has received chemotherapy or radiotherapy within 4 weeks or has received nitrosoureas or mitomycin C within 6 weeks prior to the first dose of study drug.
• The patient has received radiation to ≥ 25% of his or her bone marrow within 4 weeks of the first dose of study drug.
• The patient has received an investigational drug within 30 days of the first dose of study drug.
• Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
• History of other malignancies (except adequately treated Stage 1 cancer, cured basal cell carcinoma, superficial bladder cancer, Breast ductal carcinoma in situ (DCIS), or carcinoma in situ of the cervix) unless documented free of cancer for ≥5 years.
• The patient has not recovered to grade ≤ 1 from adverse events (AEs) due to investigational drugs or other medications, which were administered more than 4 weeks prior to the first dose of study drug.
• The patient is pregnant or lactating.
• The patient is known to be positive for the human immunodeficiency virus (HIV). The effect of BPM31510 on HIV medications is unknown. Note: HIV testing is not required for eligibility, but if performed previously and was positive, the patient is ineligible for the study.
• The patient has an inability or unwillingness to abide by the study protocol or cooperate fully with the Investigator or designee.
• The patient is receiving digoxin, digitoxin, lanatoside C or any type of digitalis alkaloids.
• The patient has uncontrolled or severe coagulopathies or a history of clinically significant bleeding within the past 6 months, such as hemoptysis, epistaxis, hematochezia, hematuria, or gastrointestinal bleeding.
• The patient has a known predisposition for bleeding such as von Willebrand's disease or other such condition.
• The patient requires therapeutic doses of any anticoagulant, including low molecular weight heparin (LMWH). Concomitant use of warfarin, even at prophylactic doses, is prohibited.

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Pancreatic Cancer
Open to Enrollment

Preoperative Extended Chemotherapy vs. Chemotherapy Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Head of the Pancreas

The purpose of this study is to compare any good and bad effects of using chemotherapy compared to chemotherapy and radiation prior to surgery. This study will allow the researchers to know whether which approach is better, the same, or worse than the other.

Investigator:
Angela Alistar, MD

The purpose of this study is to compare any good and bad effects of using chemotherapy compared to chemotherapy and radiation prior to surgery. This study will allow the researchers to know whether which approach is better, the same, or worse than the other.

A021501 | PHASE II

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Pre-Registration Eligibility Criteria:
1.Documentation of Disease:
◦Pathology: Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process. Diagnosis should be verified by local pathologist.
◦TNM Stage: TX, T1-4N0-1orNxM0*
◾M1 disease includes spread to distant lymph nodes, organs, and ascites
◦Criteria for borderline resectable disease: Local radiographic reading must be consistent with borderline resectable cancer of the pancreatic head as defined by intergroup radiographic criteria and must meet any one or more of the following on CT/MRI:
◾An interface is present between the primary tumor and the superior mesenteric vein or portal vein and measures ≥ 180° of the circumference of the vessel wall
◾Short-segment occlusion of the SMV-PV is present with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction
◾Short segment interface (of any degree) is present between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and reconstruction
◾An interface is present between the tumor and superior mesenteric artery or celiac axis measuring < 180° of the circumference of the vessel wall
◦Patients with less extensive disease than the above four (4) criteria are considered potentially resectable and are NOT eligible.
◦Patients with more extensive disease than the above 4 criteria are considered locally advanced and are NOT eligible.
◦In addition patients with the following are considered locally advanced and are NOT eligible: Any interface between the tumor and the aorta.
◦See the protocol for additional clarification and definitions of less and more extensive disease.

Registration Eligibility Criteria:
1.Disease Status - Confirmation of radiographic stage as borderline resectable disease by real-time Alliance central radiographic review
2.Prior Treatment
◦No prior chemotherapy or radiation for pancreatic cancer
◦No definitive resection of pancreatic cancer
3.Concomitant Medications
◦Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study. See the protocol for more information.
◦Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment. See the protocol for more information.
4.Medical History
◦No grade ≥ 2 neuropathy
◦No known Gilbert's Syndrome or known homozygosity for UGAT1A1*28 polymorphism
◦No uncontrolled gastric ulcer disease (Grade 3 gastric ulcer disease) within 28 days of registration
5.Pregnancy and Nursing Status - Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 7 days prior to registration is required.
6.Age ≥ 18 years
7.ECOG Performance Status 0 or 1
8.Required Initial Laboratory Values:
◦Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
◦Platelet Count ≥ 100,000/mm3
◦Creatinine ≤ 1.5 x upper limit of normal (ULN) or
◦Calc. Creatinine Clearance > 45 mL/min
◦Total Bilirubin ≤ 2.0 mg/dL
◦AST / ALT ≤ 2.5 x ULN

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Prostate Cancer
Open to Enrollment

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer

The purpose of this study is to evaluate the efficacy and safety of ARN-509 in adult men with high-risk non-metastatic castration-resistant prostate cancer.

Investigator:
Arthur Israel, MD
ARN-509-003 | PHASE III

Sponsor:
Aragon Pharmaceuticals, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Male
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features, with high risk for development of metastases
• Castration-resistant prostate cancer demonstrated during continuous androgen deprivation therapy/post orchiectomy
• Maintain castrate levels of testosterone within 4 weeks prior to randomization and throughout the study
• Patients currently receiving bone loss prevention treatment with bone-sparing agents must be on stable doses for at least 4 weeks prior to randomization
• Patients who received a first generation anti-androgen as part of an initial combined androgen blockade therapy or as second-line hormonal therapy must show continuing disease progression off the anti-androgen for at least 4 weeks prior to randomization
• At least 4 weeks must have elapsed from the use of 5-alpha reductase inhibitors, estrogens, and any other anti-cancer therapy prior to randomization
• At least 4 weeks must have elapsed from major surgery or radiation therapy prior to randomization
• Eastern Cooperative Oncology Group Performance Status 0 or 1
• Resolution of all acute toxic effects of prior therapy or surgical procedure to Grade <= 1 or baseline prior to randomization
• Adequate organ function according to protocol-defined criteria
• Administration of growth factors or blood transfusions will not be allowed within 4 weeks of the hematology labs required to confirm eligibility

Exclusion Criteria:
• Presence of confirmed distant metastases, including central nervous system and vertebral or meningeal involvement
• Symptomatic local or regional disease requiring medical intervention
• Prior treatment with second generation anti-androgens
• Prior treatment with CYP17 inhibitors
• Prior treatment with radiopharmaceutical agents, or any other investigational agent for non-metastatic castration-resistant prostate cancer
• Prior chemotherapy for prostate cancer except if administered in the adjuvant/neoadjuvant setting
• History of seizure or condition that may pre-dispose to seizure
• Concurrent therapy with protocol-defined excluded medications
• History or evidence of any of the following conditions: any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization; severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events, or clinically significant ventricular arrhythmias within 6 months prior to randomization; uncontrolled hypertension; gastrointestinal disorder affecting absorption; active infection; and, any other condition that, in the opinion of the investigator, would impair the patient's ability to comply with study procedures

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Prostate Cancer
Open to Enrollment

A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer

This is a randomized, open-label, three-arm, phase 3 study in men with biochemically recurrent prostate cancer and PSA doubling time = 9 months at the time of study entry.

Investigator:
Eric Whitman, MD
AFT-19 | PHASE III

Sponsor:
Alliance

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Histologically confirmed prostate adenocarcinoma
• Prior radical prostatectomy
• Biochemically recurrent prostate cancer with PSA doubling time ≤ 9 months at the time of study entry. Calculation of PSA doubling time should include the use of all available PSA values obtained within past 12 months prior to randomization, with a minimum of 3 values separated by at least 2 weeks apart. PSA values obtained prior to localized therapy will be excluded. PSA doubling time to be estimated using Memorial Sloan Kettering Cancer Center online calculator (https://www.mskcc.org/nomograms/prostate/psa-doubling-time)
• Prior adjuvant or salvage radiation or not a candidate for radiation based upon clinical assessment of disease characteristics and patient co-morbidities.
• Screening PSA > 0.5 ng/mL
• No definitive evidence of metastases on screening CT or MRI of abdomen/pelvis and radionuclide whole body bone scan per the judgment of the investigator. Abdominal and/or pelvic lymph nodes measuring 2 cm or less in short axis diameter are allowed. Lesions identified on other imaging modalities (e.g. PSMA or choline PET) that are not visualized on CT and/or MRI or radionuclide bone scan are allowed. Equivocal lesions on bone scan should be followed up with additional imaging as clinically indicated.
•Screening serum testosterone > 150 ng/dL
• Eastern Cooperative Oncology Group (ECOG) Performance Status grade 0 or 1
• Age ≥ 18 years
• Medications known to lower the seizure threshold (see Appendix 1) must be discontinued or substituted at least 4 weeks prior to study entry.
• Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
• Adequate organ function as defined by the following laboratory values at screening:
◦ Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) < 2.5 x upper limit of normal (ULN)
◦ Total serum bilirubin ≤1.5 x ULN. In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject may be eligible)
◦ Serum potassium ≥ 3.5 mmol/L. Supplementation and re-screening is allowed.
◦ Estimated GFR > 45 ml/min using Cockroft-Gault equation
◦ Platelets ≥ 100,000/microliter independent of transfusion and/or growth factors within 3 months prior to randomization
◦ Hemoglobin ≥ 9.0 g/dL independent of transfusion and/or growth factors within 3 months prior to randomization
◦ Serum albumin ≥ 3.0 g/dL

Exclusion Criteria:
• Prior androgen deprivation therapy and/or first generation anti-androgen (e.g. bicalutamide, nilutamide, flutamide) for biochemically recurrent prostate cancer. Prior ADT and/or first generation anti-androgen in the (neo)adjuvant and/or salvage setting before, during, and/or following radiation or surgery is allowed provided last effective dose of ADT and/or first-generation anti-androgen is > 9 months prior to date of randomization and total duration of prior therapy is ≤ 36 months.
• Prior treatment with CYP17 inhibitor (e.g. ketoconazole, abiraterone acetate, galeterone) or second generation androgen receptor antagonist including apalutamide or enzalutamide
• Prior chemotherapy for prostate cancer except if administered in neoadjuvant or adjuvant setting
• Use of 5-alpha reductase inhibitor within 42 days prior to randomization
• Use of investigational agent within 28 days prior to randomization
• Use of other prohibited medications within 7 days prior to cycle 1 day 1 on study (Arms B and C only) (see Appendix 1 for list of prohibited medications)
• Prior bilateral orchiectomy
• Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
• Uncontrolled hypertension
• Gastrointestinal disorder affecting absorption or the ability to swallow tablets
• Baseline severe hepatic impairment (Child-Pugh Class B & C)
• Intercurrent illness that is not controlled such as active infection, psychiatric illness/social situations that would limit compliance with study requirements
• Any chronic medical condition requiring a higher dose of corticosteroid than equivalent of 5 mg prednisone/prednisolone once daily

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Prostate Cancer
Open to Enrollment

A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance (ENACT)

The primary purpose of this study is to compare the time to prostate cancer progression (pathological or therapeutic progression) between patients treated with enzalutamide versus patients undergoing active surveillance.

Investigator:
David Chaikin, MD
ENACT | PHASE II

Sponsor:
Astellas Pharma Global Development, Inc

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Histologically proven adenocarcinoma of the prostate diagnosed (with ≥10 core biopsy) within 6 months of screening. The biopsy that was used for this diagnosis must be submitted for central pathology review.
• Prostate cancer categorized (as determined by central pathology review) as low risk is defined as T1c-T2a, PSA<10, N0, M0 (or presumed N0, M0 if CT/bone scan not done due to low risk of metastases), GS ≤ 6, ECOG status ≤2 and estimated life expectancy >5 years OR intermediate risk is defined as T2b-T2c, PSA<20, N0, M0 (or presumed N0, M0 if CT/bone scan not done), GS ≤7 (3+4 pattern only), ECOG status ≤ 2 and estimated life expectancy > 5 years. Prostate cancer categorized (as determined by central pathology review) to the very low risk category (T1c, GS ≤6, PSA <10 ng/mL, fewer than 3 prostate biopsy cores positive,
≤50% cancer in any core, PSA density <0.15 ng/mL/g) is not included.
• Ability to swallow study drugs and to comply with study requirements throughout the study
• Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures
• Throughout study, male subject and a female partner who is of childbearing potential must use two acceptable methods of birth control (one of which must include a condom barrier method of contraception) starting at screening and continuing throughout the study period and for three months after the final study drug administration. Two acceptable methods of birth control thus include the following:
1. Condom (barrier method of contraception) AND
2. One of the following is required:
i. Established use of oral, injected or implanted hormonal methods of contraception by the female partner; ii. Placement of an intrauterine device or intrauterine system by the female partner; iii. Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam / gel / film / cream / suppository by the female partner; iv. Tubal ligation in the female partner.
• Must not donate sperm starting at screening throughout the study period and for 90 days after the final study drug administration.

Exclusion Criteria:
• Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer
• Very low risk category (T1c, GS ≤6, PSA <10 ng/mL, fewer than 3 prostate biopsy cores positive, ≤50% cancer in any core, PSA density <0.15 ng/mL/g)
• Prior transurethral resection of the prostate or prior transurethral microwave thermotherapy of the prostate
• Use of oral glucocorticoids within 1 month of screening
• Use of 5 alpha reductase inhibitor within 1 month of screening or total use, within the last two years prior to screening, of >3 months
• Presence of metastatic disease
• History of seizure or any condition that may predispose to seizures at any time in the past. History of loss of consciousness or transient ischemic attack within 12 months of screening
• Absolute neutrophil count < 1,500/μL, platelet count < 100,000/μL, or hemoglobin < 6.2 mmol/L (10 g/dL) at screening
• Total bilirubin >1.5 times the upper limit of normal (ULN) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 X ULN at screening
• Creatinine > 177 μmol/L (> 2 mg/dL) at screening
• Albumin < 30 g/L (3.0 g/dL) at screening
• Major surgery within 4 weeks prior to Randomization Visit
• Clinically significant cardiovascular disease including:
1. Myocardial infarction or uncontrolled angina within 6 months
2. Congestive heart failure New York Heart Association (NYHA) class 3 or 4
3. History of clinically significant ventricular arrhythmias
4. History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place
5. Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mm Hg) at screening
6 .Bradycardia as indicated by a heart rate of < 45 beats per minute on the screening electrocardiogram (ECG) and on physical examination
7. Uncontrolled hypertension as indicated by at least 2 consecutive measurements of a resting systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the Screening Visit
• Known hypersensitivity to enzalutamide or any of its components.
• Subject has received investigational therapy within 28 days or 5 half lives, whichever is longer, prior to screening

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Prostate Cancer
Open to Enrollment

ATLAS: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment With Primary Radiation Therapy

The purpose of this study is to determine if JNJ-56021927 plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy results in an improvement of metastasis-free...

Investigator:
Arthur Israel, MD

survival.

56021927PCR3003 | PHASE III

Sponsor:
Janssen R & D

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Male
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Age >= 18 years
• Indicated and planned to receive primary radiation therapy for prostate cancer
• Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis: 1) Gleason score >=8 and >=cT2c, 2) Gleason score >=7, PSA >=20 nanogram per milliliters (ng/mL), and >=cT2c
• Charlson index (CCI) <=3
• An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1
• Adequate liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), <2 * upper limit of normal (ULN) and total bilirubin <1.5 * ULN
• Participants who are sexually active (even men with vasectomies) and willing to use a condom and agree not to donate sperm during the trial
• Signed, written, informed consent
• Be able to swallow whole study drug tablets

Exclusion Criteria: -
• Presence of distant metastasis, including pelvic nodal disease below the iliac bifurcation >2 cm in the short axis
• Prior treatment with gonadotropin releasing hormone (GnRH) analogue or anti-androgen or both for >3 months prior to randomization
• Bilateral orchiectomy
• History of pelvic radiation
• Prior systemic (example [e.g.], chemotherapy) or procedural (e.g., prostatectomy, cryotherapy) treatment for prostate cancer
• History of seizure or condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness <= 1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
• Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents for prostate cancer
• Prior treatment with radiopharmaceutical agents (e.g., strontium-89) or immunotherapy (e.g., sipuleucel-T) for prostate cancer
• Prior treatment with systemic glucocorticoids ≤4 weeks prior to randomization or is expected to require long-term use of corticosteroids during the study
• Use of 5-alpha reductase inhibitors (e.g., dutasteride, finasteride) <=4 weeks prior to randomization
• Use of any investigational agent <=4 weeks prior to randomization
• Current chronic use of opioid analgesics for >=3 weeks for oral or >7 days for non-oral formulations
• Major surgery <=4 weeks prior to randomization
• Current or prior treatment with anti-epileptic medications for the treatment of seizures
• Gastrointestinal conditions affecting absorption
• Known or suspected contraindications or hypersensitivity to JNJ-56021927, bicalutamide or GnRH agonists or any of the components of the formulations
• Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject

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Seizures
Open to Enrollment

An Open-label, Multi-center Long-term Safety Roll-over Study in Patients With Tuberous Sclerosis Complex (TSC) and Refractory Seizures Who Are Judged by the Investigator to Benefit From Continued Treatment With Everolimus After Completion of Study CRAD001M2304.

The purpose of this study is to evaluate the long-term safety in patients with TSC and refractory seizures who are currently receiving everolimus treatment in the Novartis-sponsored EXIST-3 study and who are determined to be benefiting from continued treatment...

Investigator:
Harvey Bennett, MD

as judged by the investigator at the completion of EXIST-3.

RAD001M2X02B | PHASE III

Sponsor:
Novartis Pharmaceuticals Corporation - NJ

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 2 Years to 65 Years (Child, Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Key Inclusion Criteria:
• Patient is currently enrolled in the Novartis-sponsored EXIST-3 study, receiving everolimus, and has fulfilled all its requirements
• Patient is currently benefiting from treatment with everolimus, as determined by the Investigator.
• Patient has demonstrated compliance, as assessed by the Investigator,with the parent study protocol requirements.
• Patient is willing and able to comply with scheduled visits and treatment plans.
• Written informed consent/adolescent assent obtained prior to enrolling into the roll-over study.

Key Exclusion Criteria:
• Patient has been permanently discontinued from everolimus study treatment in EXIST-3 study
• Everolimus is approved for patients with TSC and refractory seizures and is reimbursed in the local country.
• Patients who are receiving everolimus in combination with unapproved or experimental treatments for seizure control Anti-epileptic drug (AEDs) are allowed for the purpose of seizure control.

Contact:
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Skin Cancer
Open to Enrollment

A Multicenter Phase 2, Open-Label Trial of Intratumoral pIL-12 Plus Electroporation in Combination With Intravenous Pembrolizumab in Patients With Stage III/IV Melanoma Who Are Progressing on Either Pembrolizumab or Nivolumab Treatment

This will be a Phase 2 study of intratumoral pIL-12-EP plus IV pembrolizumab. Eligible patients will be those with pathological diagnosis of unresectable or metastatic melanoma who are progressing or have progressed on pembrolizumab or nivolumab..

Investigator:
Eric Whitman, MD
OMS-I103 | PHASE II

Sponsor:
OncoSec Medical Incorporated

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
•In order to be eligible for participation in this trial, the patient must meet all the following:
1. Pathologically documented unresectable melanoma, AJCC Stage III or IV. Patients must have histological or cytological confirmed diagnosis of unresectable melanoma with progressive locally advanced or metastatic disease.
2. Patients must be refractory to anti-PD-1 monoclonal antibodies (mAb) defined as pembrolizumab or nivolumab as either as monotherapy or in combination with other approved checkpoint inhibitors or targeted therapies according to their approved label, defined as (patients must meet all of the following criteria):
1. Received at least 4 doses of anti-PD1 mAb for pembrolizumab; minimum dose of 240 mg given every two weeks for nivolumab in monotherapy; minimum dose of 1 mg/kg given Q3W for nivolumab in combination with ipilimumab
2. Progressive disease after anti-PD1 mAb will be defined according to RECIST v1.1.
3. Documented disease progression within 24 weeks of the last dose of anti-PD1 mAb.
3. Resolution/improvement of anti-PD1 mAb-related AEs
1. No history of common toxicity criteria adverse events (CTCAE) Grade 4 irAEs from anti-PD1 mAb.
2. No history of CTCAE Grade 3 requiring steroid treatment (>10 mg/day prednisone or equivalent dose) for >12 weeks or CTCAE Grade 2 pneumonitis regardless of steroid treatment.
3. Minimum of 4 weeks (washout period) from the last dose of anti PD1 mAb.
4. Prior treatment with an approved BRAF inhibitor if BRAF V600 mutation-positive.
5. Age ≥ 18 years of age on day of signing informed consent.
6. Has a performance status of 0 or 1 on the ECOG Performance Scale.
7. Have measurable disease based on RECIST v1.1, with at least one anatomically distinct lesion. Lesion or lesions must meet all the following baseline criteria:
1. Accessible for electroporation,
2. Must be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded)
8. Demonstrate adequate organ function as defined below. All screening laboratories should be performed within 10 days of treatment initiation.
System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥1.5 × 109/L Platelets ≥100 × 109/L Hemoglobin ≥9 g/dL or ≥5.6 mmol/L Renal Creatinine* OR ≤1.5 × the upper limit of normal (ULN) OR Measured or calculated creatinine clearance (CrCl) Glomerular filtration rate (GFR) can also be used instead of creatinine or CrCl ≥ 60 mL/min for patient with creatinine levels >1.5 × institutional ULN Hepatic Total bilirubin ≤1.5 × ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels > 1.5× ULN Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN OR ≤5 × ULN for patients with liver metastases Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 × ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants Activated Partial Thromboplastin Time (aPTT)
* Creatinine clearance should be calculated per institutional standard.
9. Women of childbearing potential must have negative serum or urine pregnancy test within 72 hours prior to receiving the first study drug administration.
10. For women of childbearing potential, must be willing to use an adequate method of contraception from 30 days prior to the first study drug administration and 120 days following last day study drug administration
11. Male patients of childbearing potential must be surgically sterile, or must agree to use adequate method of contraception during the study and at least 120 days following the last day of study drug administration.
12. Able and willing to provide written informed consent and to follow study instructions.


Exclusion Criteria:
The patient must be excluded from participating in the trial if meet any of the following:
1. Patient has disease that is suitable for local therapy administered with curative intent.
2. Patient with a diagnosis of uveal melanoma.
3. Patient has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
4. Clinically active cerebral or non-measurable bone-only metastases. Patients with up to 3 (neurological performance status of 0) cerebral metastases may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy or gamma-knife therapy with no evidence of progression, and have not required steroids, for at least two months prior to enrolment.
5. Greater than 3 sites of visceral metastases. For patients with less than or equal to 3 visceral metastases and liver lesions must meet RECIST v1.1 criteria for SD for at least 1 month prior to enrolment.
6. Patients with electronic pacemakers or defibrillators.
7. Patients who have a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
8. Patients who have known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected); Note: Patients who have been vaccinated against Hepatitis B and who are positive only for the Hepatitis B surface antibody are permitted to participate in the study.
9. Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
10. Patients who have received a live-virus vaccination within 30 days of the first dose of treatment. Seasonal flu vaccines that do not contain live virus are permitted.
11. Patient has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
12. Patients who have received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including G-CSF, GM-CSF or recombinant erythropoietin) within 4 weeks prior to study Cycle 1, Day 1 (baseline).
13. Patient has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
14. Patient has a history of interstitial lung disease.
15. Patient has an active infection requiring systemic therapy.
16. Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
17. Patient has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
Note: Patients with ≤Grade 2 neuropathy or ≤Grade 2 alopecia are an exception to this criterion and may qualify for the study.
Note: If patient underwent major surgery or radiation therapy of >30 Gy, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study combination therapy.
18. Participation in another clinical trial within 30 days of screening. Note: Patients participating in an observational study are an exception to this criterion and may qualify for the study with Sponsor approval
19. Patients who have had any targeted small molecule therapy or any immunotherapeutic after their confirmed progression on anti-PD-1 therapy.
20. Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
21. Patients who are pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.

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Skin Cancer
Open to Enrollment

A Phase 1b/2, Open-label, Multicenter, Dose Escalation and Expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma

This is a Phase 1b/2 open-label trial to assess the safety, tolerability, biologic-activity, and preliminary efficacy of intratumoral SD-101 injections in combination with intravenous pembrolizumab in patients with advance or metastatic melanoma.

Investigator:
Eric Whitman, MD
DV3-MEL-01 | PHASE I/II

Sponsor:
Dynavax Technologies Corporation

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria: (Phase 1b and Phase 2)
• Histologically or cytologically confirmed unresectable in-transit (stage IIIc) or metastatic (stage IV) melanoma.
• At least 1 site of disease which must be palpable and easily accessible for intratumoral injection. A second measurable lesion is desirable in Phase 1 and required in Phase 2.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1

Inclusion Criteria (Phase 2 Only)
• Expansion Cohort 2: Must have documented PD per RECIST 1.1 while receiving a prior FDA-approved anti-PD-1 therapy.

Exclusion Criteria: (Phase 1b and Phase 2)
• Stage IIIc melanoma considered resectable with curative intent.
• Is expected to require any other form of anti-cancer therapy while in the trial.
• Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
• History of or current uveal or ocular melanoma.
• Active infection including cytomegalovirus.
• Active autoimmune disease requiring systemic treatment.
• History of interstitial lung disease.
• Known active central nervous system metastases or carcinomatous meningitis.

Exclusion Criteria (Phase 2, Expansion Cohort 1 Only).
• Prior therapy with combination of talimogene laherparepvec (T-VEC) and an anti-PD-1/L1 agent or an investigational agent targeting immunoregulatory receptors or mechanisms (exceptions are prior BRAF inhibitor, single agent T-VEC, and ipilumumab, which are allowed.)
• Prior therapy with a anti-PD1/L1 agent

Exclusion Criteria (Phase 2, Expansion Cohort 2 only)
• Prior therapy with a combination of T-VEC and an anti-PD-1/L1 agent or an investigational agent targeting immunoregulatory receptors or mechanisms (exceptions are prior ipilumumab, single agent T-VEC, nivolumab, pembrolizumab, or other anti-PD-1/L1 agents which are allowed).

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Skin Cancer
Open to Enrollment

A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1, in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

The primary objective is to estimate the overall response rate (ORR) for metastatic Basal Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when treated with REGN2810 as a monotherapy.

Investigator:
Eric Whitman, MD
R2810-ONC-1620 | PHASE II

Sponsor:

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Confirmed diagnosis of invasive BCC
• Progression of disease on hedgehog inhibitor (HHI) therapy or intolerance of prior HHI therapy
• At least 1 measurable lesion
• ≥18 years of age
• Hepatic function, renal function, bone marrow function in defined lab-value-ranges
• Anticipated life expectancy >12 weeks
• Consent to provide archived tumor biopsy material (all patients)
• Group 2: consent to undergo research biopsies
• Group 2: must not be a candidate for radiation therapy or surgery
• Comply with study procedures and site visits
• Sign Subject Information Sheet and Informed Consent Form

Exclusion Criteria:
• Ongoing or recent significant autoimmune disease
• Prior treatment with specific pathway-blockers (PD-1/PD-L1)
• Prior treatment with immune-modulating agents within 28 days before REGN2810
• Untreated brain metastasis that may be considered active
• Immunosuppressive corticosteroid doses (>10mg prednisone) within 28 days prior to treatment with REGN2810
• Active infections requiring therapy, including HIV, hepatitis
• Pneumonitis within the last 5 years
• Cancer treatment other than radiation therapy, including investigational or standard of care, within 30 days prior to treatment with REGN2810
• Documented allergic reactions or similar to antibody treatments
• Concurrent malignancies other than BCC, other than those with negligible risk of metastases or death
• Any acute or chronic psychiatric problems
• Having received a solid organ transplantation
• Inability to undergo contrast radiological assessments
• Breastfeeding, pregnant, women of childbearing potential not using contraception
Note: Other protocol-defined inclusion/exclusion criteria apply

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Skin Cancer
Open to Enrollment

A Phase 2, Multicenter, Single-arm Study to Assess the Safety, Feasibility, and Efficacy of Cell Transfer Therapy Using Autologous Tumor Infiltrating Lymphocytes (LN-144) Followed by IL-2 for Treatment of Metastatic Melanoma

Prospective, single-arm interventional study evaluating autologous tumor infiltrating lymphocyte (TIL) infusion (LN-144) followed by IL-2 after a non-myeloablative chemotherapy preparative regimen for the treatment of metastatic melanoma.

Investigator:
Eric Whitman, MD
C-144-01 | PHASE II

Sponsor:
Iovance Biotherapeutics, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 70 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria Patients must have:
• Measurable metastatic melanoma and at least one lesion that is resectable for TIL generation. The lesion must be of at least 1.5 cm in diameter and can be surgically removed with minimal morbidity (defined as any operation for which expected hospitalization is less than or equal to three days).
• Undergone at least one prior systemic treatment for metastatic melanoma.
• Progressive disease after prior treatment.
• Be between 18 and 70 years of age, inclusive, at the time of consent.
• An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Be capable of participating and completing study procedures.
• Patients of childbearing potential or with partners of childbearing potential must be willing to practice birth control during treatment and for four months after receiving all protocol related therapy.
• Serum absolute neutrophil count (ANC) greater than 1000/mm3, hemoglobin greater than 9.0 g/dL, and platelet count greater than 100,000/mm3.
• Serum ALT/SGPT and AST/SGOT less than three times the upper limit of normal (<3x ULN), a calculated creatinine clearance of greater than 50 mL/min (>50 mL/min), and a total bilirubin less than or equal to 2 mg/dL (≤ 2 mg/dL). Patients with Gilbert's Syndrome must have a total bilirubin less than 3 mg/dL (<3 mg/dL).
• Seronegative for the HIV antibody, hepatitis B antigen, and hepatitis C antibody or antigen.
• EBV IgG positive to viral capsid antigen
• Not have received systemic therapy for melanoma for a minimum of four weeks prior to the point of enrollment. Prior therapy-related toxicities must have recovered to Grade 1 or less (CTCAE v4.03), except for alopecia or vitiligo.
Note: Patients may have undergone minor surgical procedures not involving general anesthesia within the past three weeks, as long as all toxicities have recovered to Grade 1 or less or as specified in the eligibility criteria.
• A minimum of at least five weeks must have elapsed since any prior anti-CTLA4 antibody therapy to allow antibody levels to decline.
• Patients with documented Grade 2 or greater diarrhea or colitis as a result of previous treatment with ipilimumab, tremelimumab, anti-PD1 or anti-PD-L1 antibodies must have had a normal colonoscopy, including biopsy specimens.
• Ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an institutional review board (IRB), and agree to abide by the study restrictions and return to the site for the required assessments.
• Patients have provided written authorization for use and disclosure of protected health information.

Exclusion Criteria:
• Received prior cell transfer therapy which included a non-myeloablative or myeloablative chemotherapy regimen.
• More than three brain metastases. Note: Patients with fewer metastases may be eligible. If lesions are symptomatic or greater than or equal to 1 cm each, these lesions must have been definitively treated and stable for one month. Brain metastases with significant edema and metastases larger than 2 cm are exclusionary.
• Pregnant or breastfeeding.
• Systemic steroid therapy regimen defined as the need for chronic steroid use for at least seven or more days at a dose of 10 mg of prednisone or equivalent per day.
• Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced in the medical history by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
• Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
• History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or IL-2.
• History of coronary revascularization or ischemic symptoms.
• History of a positive HIV test or active Hepatitis B or C.
• Estimated glomerular filtration rate (eGFR) less than 40 mL/min using the Cockcroft Gault formula at Screening or have end-stage renal disorder requiring hemodialysis.
• An LVEF less than 45%. (Older patients [60 - 70 years] must have received an echocardiogram within the previous 60 days demonstrating LVEF ≥ 45%).
• History of cigarette smoking of at least 20 packs/year within the past two years that have a documented FEV1 (forced expiratory volume in one second) of less than or equal to 60% or symptoms of respiratory dysfunction.
• Had another primary malignancy within the previous three years (with the exception of carcinoma in situ of the breast, urothelial cancer in situ, and non-melanoma skin cancer that has been adequately treated)

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Skin Cancer
Open to Enrollment

A Phase III, Open-Label, Multicenter, Two Arm, Randomized Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced BRAF V600 Wild-Type Melanoma

This is a Phase III, multicenter, open-label, randomized study designed to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma.

Investigator:
Eric Whitman, MD

This is a Phase III, multicenter, open-label, randomized study designed to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma.

CO39722 | PHASE III

Sponsor:
Genentech, Inc

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
Disease-Specific Inclusion Criteria
• Histologically confirmed Stage IV (metastatic) or unresectable Stage IIIc (locally advanced) melanoma
• Naive to prior systemic anti-cancer therapy for melanoma
• Documentation of BRAFV600 wild-type status in melanoma tumor tissue through use of a clinical mutation test approved by the local health authority
• A representative, formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 20 slides containing unstained, freshly cut, serial sections must be submitted along with an associated pathology report prior to study entry. If 20 slides are not available or the tissue block is not of sufficient size, the patient may still be eligible for the study, after discussion with and approval by the Medical Monitor
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Age >=18 years at time of signing Informed Consent Form
• Ability to comply with the study protocol, in the investigator's judgment
• Histologically or cytologically confirmed BRAFV600 wild-type melanoma
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Life expectancy >=3 months
• Adequate hematologic and end-organ function
• For women of childbearing potential: agreement to remain abstinent or use at least two forms of effective contraceptive with a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of cobimetinib and at least 5 months after the last dose of atezolizumab or pembrolizumab
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures (e.g. condom), and agreement to refrain from donating sperm, for at least 3 months after the last dose of cobimetinib
• Willingness and ability of participants to use an electronic device to report selected study outcomes

Exclusion Criteria:
General Exclusion Criteria
• Inability to swallow medications
• Malabsorption condition that would alter the absorption of orally administered medications
• Pregnancy, breastfeeding, or intention of becoming pregnant during the study
• History of severe hypersensitivity reactions to components of the cobimetinib, atezolizumab, or pembrolizumab formulations
• Current or recent treatment with therapeutic antibiotics, live attenuated vaccines or systemic immunostimulatory/immunosuppresive medication
• Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study Cancer-Related Exclusion Criteria
• Ocular melanoma
• Major surgery or radiotherapy within 21 days prior to Day 1 of Cycle 1 or anticipation of needing such procedure while receiving study treatment
• Uncontrolled tumor-related pain
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days
• Active or untreated central nervous system (CNS) metastases Exclusions Related to Cardiovascular Disease
• Unstable angina, new-onset angina within last 3 months, myocardial infarction within the last 6 months prior to Day 1 of Cycle 1, or current congestive heart failure classified as New York Heart Association Class II or higher
• Left ventricular ejection fraction (LVEF) below institutional lower limit of normal or <50%, whichever is lower
• Poorly controlled hypertension, defined as sustained, uncontrolled, non-episodic baseline hypertension consistently above 159/99 mmHg despite optimal medical management
• History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third degree heart block, or evidence of prior myocardial infarction Exclusions Related to Infections
• HIV infection
• Active tuberculosis infection
• Severe infections within 4 weeks prior to Day 1 of Cycle 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
• Signs or symptoms of clinically relevant infection within 2 weeks prior to Day 1 of Cycle 1
• Treatment with oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1
• Active or chronic viral hepatitis B or C infection Exclusions Related to Ocular Disease
• Known risk factors for ocular toxicity Exclusions Related to Autoimmune Conditions and Immunomodulatory Drugs
• Active or history of autoimmune disease or immune deficiency
• Prior allogeneic stem cell or solid organ transplantation
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
• Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1, Cycle 1 Exclusions Related to Other Medical Conditions or Medications
• Active malignancy (other than melanoma) or a prior malignancy within the past 3 years
• Any Grade >=3 hemorrhage or bleeding event within 28 days of Day 1 of Cycle 1
• History of stroke, reversible ischemic neurological defect, or transient ischemic attack within 6 months prior to Day 1
• Proteinuria >3.5 gm/24 hr
• Consumption of foods, supplements, or drugs that are strong or moderate CYP3A4 enzyme inducers or inhibitors at least 7 days prior to Day 1 of Cycle 1 and during study treatment

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Skin Cancer
Open to Enrollment

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Vemurafenib (RO5185426) Adjuvant Therapy in Patients with Surgically Resected, Cutaneous Braf-Mutant Melanoma at High Risk for Recurrence

This multi-center, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in patients with completely resected, cutaneous BRAF-mutation positive melanoma at high risk for recurrence. Patients will be randomized...

Investigator:
Eric Whitman, MD

to receive oral doses of vemurafenib 960 mg twice daily or matching placebo. The anticipated time on study treatment is 52 weeks.

GO27826 | PHASE III

Sponsor:
Genentech, Inc

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Patients with completely resected, histologically confirmed, Stage IIC or Stage III, cutaneous melanoma where the BRAFV600 mutation status of the current primary tumor or involved lymph node is determined to be positive using the cobas® BRAF V600 Mutation Test. Patients with Stage IIIA disease must have at least one lymph node metastasis measuring > 1 mm in diameter
• Patients must have been surgically rendered free of disease within 70 days of randomization
• Eastern Cooperative Oncology Group performance status of 0 or 1
• Life expectancy of at least 5 years
• Patients must have fully recovered from the effects of any major surgery or significant traumatic injury prior to the first dose of study treatment
• Adequate hematologic, hepatic and renal function

Exclusion Criteria:
• History of any systemic therapy for the treatment of melanoma
• History of limb perfusion therapy
• History of radiotherapy for the treatment of melanoma
• Invasive malignancy other than melanoma at the time of enrollment or within 3 years prior to first dose of study treatment
• Family history of colon cancer syndromes
• History of clinically significant cardiac or pulmonary dysfunction
• Major surgical procedure within 4 weeks prior to first dose of study treatment
• Infection with human immunodeficiency virus, hepatitis B or hepatitis C virus

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Skin Cancer
Completed

A Prospective Observational Study of Treatment Patterns and Effectiveness and Safety Outcomes in Advanced Basal Cell Carcinoma and Basal Cell Carcinoma Nevus Syndrome Patients

This multi-center, prospective, observational cohort study will evaluate the effectiveness, safety and utilization of treatments in patients with advanced basal cell carcinoma and basal cell carcinoma nevus syndrome. The total study duration is anticipated...

Investigator:
Eric Whitman, MD

to be a maximum of 8 years, including 3 years for patient recruitment and 5 years follow-up.

ML28296

Sponsor:
Genentech, Inc

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample

Study Population
Patients treated for advanced basal cell carcinoma and basal cell carcinoma nevus syndrome

Inclusion Criteria:
• Adult patients, >/= 18 years of age
• Patients with basal cell carcinoma (BCC) who meet either of the following definitions:
o Patients who were determined with advanced disease (aBCC) within 90 days prior to study enrollment, have not been diagnosed with basal cell carcinoma nevus syndrome (BCCNS) and have not been treated with an investigational or approved hedgehog pathway inhibitor
o Patients with aBCC who have not been diagnosed with BCCNS and who were previously treated with vismodegib as part of Genentech study SHH4476g, SHH4437g, or SHH4811g (EAP)
o Patients with BCCNS who either have aBCC or multiple BCCs of any stage as defined by protocol (may include patients previously enrolled in Genentech study SHH4476g, SHH4437g, or SHH4811g (EAP))
Exclusion Criteria:
• Participation in a clinical trial within 90 days prior to study enrollment that has either involved treatment of aBCC or involved treatment with an investigational or approved hedgehog pathway inhib

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Skin Cancer
Open to Enrollment

A Randomized Phase III Trial of Dabrafenib + Trametinib Followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab Followed by Dabrafenib + Trametinib at Progression in Patients With Advanced BRAFV600 Mutant Melanoma

This randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating...

Investigator:
Eric Whitman, MD

patients with stage III-IV melanoma that contains a mutation known as v-raf murine sarcoma viral oncogene homolog B V600 (BRAFV600) and cannot be removed by surgery. Ipilimumab and nivolumab may block tumor growth by targeting certain cells. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.

EA6134 | PHASE III

Sponsor:
Eastern Cooperative Oncology Group

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• STEP 1
• Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1
• Women must not be pregnant or breast-feeding
◦ All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
◦ A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Women of child-bearing potential and sexually active males must agree to use at least two other accepted and effective methods of contraception and/or to abstain from sexual intercourse for the duration of their participation in the study, and for 4 weeks after treatment with dabrafenib or for 4 months after dabrafenib in combination with trametinib; women of child-bearing potential must use at least two other accepted and effective methods of contraception and/or to abstain from sexual intercourse for at least 23 weeks after the last dose of nivolumab and/or ipilimumab and sexually active males must use at least two other accepted and effective methods of contraception and/or abstain from sexual intercourse for at least 31 weeks after the last dose of nivolumab and/or ipilimumab; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately
• Patients must have unresectable stage III or stage IV disease
• Patients must have measurable disease; all sites of disease must be evaluated within 4 weeks prior to randomization
• Patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive
• Patients must have BRAFV600E or BRAFV600K mutations, identified by a Food and Drug Administration (FDA)-approved test at a Clinical Laboratory Improvement Amendments (CLIA)-certified lab; if test at CLIA-certified lab used a non-FDA approved method, information about the assay must be provided (FDA approved tests for BRAF V600 mutations in melanoma include: THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test)
• Patients may have had prior systemic therapy in the adjuvant setting; however this adjuvant treatment must not have included a cytotoxic T-lymphocyte-associated protein 4 (CTLA4) or programmed cell death 1 (PD1) pathway blocking antibody or a BRAF/MEK inhibitor; also, patients may not have had any prior systemic treatment for advanced (measurable metastatic) disease
• Patients must have discontinued chemotherapy, immunotherapy or other investigational agents used in the adjuvant setting >= 4 weeks prior to entering the study and recovered from adverse events due to those agents; mitomycin and nitrosoureas must have been discontinued at least 6 weeks prior to entering the study; patients must have discontinued radiation therapy >= 2 weeks prior to entering the study and recovered from any adverse events associated with treatment; prior surgery must be >= 4 weeks from registration and patients must be fully recovered from post-surgical complications
• Patients must not receive any other investigational agents while on study or within four weeks prior to registration
• Patients are ineligible if they have any currently active central nervous system (CNS) metastases; patients who have treated brain metastases (with either surgical resection or stereotactic radiosurgery [SRS]) that have been stable on head magnetic resonance imaging (MRI) or contrast computed tomography (CT) scan for at least 4 weeks following treatment and within 4 weeks of randomization could be eligible; patients must not have taken any steroids =< 14 days prior to randomization for the purpose of managing their brain metastases; patients with only whole brain irradiation for treatment of CNS metastases will be ineligible
• Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast; patients with other malignancies are eligible if they have been continuously disease-free for > 3 years prior to the time of registration; patients with history of rat sarcoma (RAS) mutation-positive tumors are not eligible regardless of interval from the current study; Note: prospective RAS testing is not required; however, if the results of previous RAS testing are known, they must be used in assessing eligibility
• White blood count >= 3,000/uL
• Absolute neutrophil count (ANC) >= 1,500/uL
• Platelet count >= 100,000/uL
• Hemoglobin > 9 g/dL
• Serum creatinine =< 1.5 x upper limit of normal (ULN) or serum creatinine clearance (CrCl) >= 40 ml/min
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (=< 5 x ULN for patients with documented liver metastases)
• Alkaline phosphatase =< 2 x ULN (=< 5 x ULN for patients with known liver involvement and =< 7 x ULN for patients with known bone involvement)
• Total bilirubin =< 1.5 x ULN except subjects with normal direct bilirubin or those with known Gilbert's syndrome
• Serum lactate dehydrogenase (LDH) < 10 X ULN (patients with LDH > 10 X ULN are felt to have aggressive disease and should be considered for BRAF inhibitor therapy off protocol)
• Patients must not have any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), including but not limited to, ongoing or active infection requiring parenteral antibiotics on day 1, history of bleeding diathesis or need for concurrent anticoagulation (international normalized ratio [INR] =< 1.5 and partial thromboplastin time [PTT] within 1.1 x ULN), or psychiatric illness/social situations that would limit compliance with study requirements, interfere with subject's safety, or obtaining informed consent; therapeutic level dosing of warfarin can be used with close monitoring of prothrombin time (PT)/INR by the site; exposure may be decreased due to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted based upon PT/INR; consequently, when discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin dose adjustments must be made as clinically appropriate; prophylactic low dose warfarin may be given to maintain central catheter patency
• Patients must not have a history of or evidence of cardiovascular risks including any of the following:
◦ QT interval corrected for heart rate using the Bazett's formula (QTcB) >= 480 msec. at baseline
◦ History of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within the past 24 weeks prior to registration
◦ History prior to registration or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system
◦ Left ventricular ejection fraction (LVEF) =< lower limit of normal on cardiac echocardiogram (echo) or multi gated acquisition scan (MUGA)
◦ Intra-cardiac defibrillator
◦ Abnormal cardiac valve morphology (>= grade 2) documented by ECHO (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study
◦ History or evidence of current clinically significant uncontrolled cardiac arrhythmias; clarification: subjects with atrial fibrillation controlled for > 30 days prior to dosing are eligible
◦ Treatment refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy
• Individuals who are known to be human immunodeficiency virus (HIV) infected are eligible (note: HIV testing is not required for entry into the study)
• Patients with evidence of active hepatitis B virus (HBV) or hepatitis C Virus (HCV) infection are not eligible; patients with cleared HBV and HCV infection will be allowed
• Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), should be evaluated for the presence of target organ involvement and potential need for systemic treatment; if no systemic immune suppression is deemed necessary they can be eligible
• The following medications or non-drug therapies are also prohibited while on treatment in this study:
◦ Other anti-cancer therapies
◦ Other investigational drugs
◦ Patients taking any medications or substances that are strong inhibitors or inducers of cytochrome P450 family 3, subfamily A (CYP3A) or cytochrome P450 family 2, subfamily C, polypeptide 8 (CYP2C8) are ineligible
• Patients must not have history of retinal vein occlusion (RVO)
• Patients must not have evidence of interstitial lung disease or pneumonitis
• Patients must not have malabsorption, swallowing difficulty, or other conditions that would interfere with the ingestion or absorption of dabrafenib or trametinib
• STEP 2 (CROSSOVER ARM FOR PATIENTS WITH PROGRESSIVE DISEASE)
• The patient must have met all eligibility criteria (except as detailed below) at the time of crossover
◦ RECIST defined measurable disease is not required
◦ Only prior systemic therapy as part of step 1 is allowed
◦ Malabsorption, swallowing difficulty, or other conditions that would interfere with the ingestion or absorption of dabrafenib or trametinib, or history of retinal vein occlusion are acceptable for patients crossing over to ipilimumab + nivolumab treatment
◦ History of autoimmune disease, excluding interstitial lung disease or pneumonitis, is allowed in patients crossing over to dabrafenib/trametinib therapy
◦ Patients can be less than 4 weeks from surgery or SRS to CNS metastases
◦ There is no restriction on serum LDH at crossover
◦ Patients with a history of cardiovascular risks that developed during step 1 of therapy should be discussed with study principal investigator (PI) at time of crossover
• Patients must have melanoma that is metastatic and clearly progressive on prior therapy
• Patients must be at least 2 weeks and within 12 weeks from documented progressive disease (PD) on Step 1 of current study; all sites of disease must be evaluated within 4 weeks prior to registration
• Patients must have recovered from adverse events (toxicities resolved to grade 1 or less) of prior therapy; patients with immune related toxicities from ipilimumab + nivolumab may continue onto Step 2 even if still on steroids to control side effects, so long as toxicity has resolved to grade 1 or less
• Patients must have discontinued radiation therapy >= 2 weeks prior to registering to Step 2 of the study and recovered from any adverse events associated with treatment; prior surgery must be >= 2 weeks from registration to Step 2 and patients must be fully recovered from post-surgical complications
• Patients are ineligible if they have any currently active CNS metastases; patients who have treated brain metastases (with either surgical resection or SRS) that have been stable on head MRI or contrast CT scan for at least 4 weeks following treatment and within 4 weeks prior to Step 2 registration are eligible; patients crossing over to ipilimumab + nivolumab must not have taken any steroids =< 14 days prior to registration for the purpose of managing their brain metastases; this exclusion does not apply for patients crossing over to dabrafenib + trametinib; patients with only whole brain irradiation for treatment of CNS metastases are ineligible
• Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast

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Skin Cancer
Open to Enrollment

A Randomized, Controlled, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients With Hepatic-Dominant Ocular Melanoma

This study will evaluate two groups of patients who have melanoma that has spread from the eye to the liver: one group (50%) will get high-dose chemotherapy delivered specifically to the liver, while the other group (50%) will get one of 4 standard best alternative...

Investigator:
Eric Whitman, MD

care treatments. Patients in each group will get repeating cycles of treatment until the cancer in the liver advances and will be followed until death. This study will evaluate the effect of the treatments on how long patients live and how long it takes for the cancer to advance or respond to the treatment.

PHP-OCM-301 | PHASE III

Sponsor:
Delcath Systems, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 90 Years (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Male or female patients ≥ 18 years of age.
2. Patients must weigh ≥ 35 kg (due to possible size limitations with respect to percutaneous catheterization of the femoral artery and vein using the Delcath Hepatic Delivery System).
3. 50% or less histologically or cytologically-proven ocular melanoma metastases in the parenchyma of the liver.
4. Disease in the liver must be measurable by computed tomography (CT) and/or magnetic resonance imaging (MRI).
5. Evidence of limited extrahepatic disease on preoperative radiological studies is acceptable if the life threatening component of PD is in the liver. Limited extrahepatic disease is defined in this protocol as follows: metastasis in up to one other organ (bone, subcutaneous, or pulmonary), limited to up to 2 nodules and amenable to resection or radiation. The extrahepatic lesions should be no larger than 2 cm in diameter each. The rationale for permitting this limited extrahepatic disease is that these types of lesions are amenable to surgical resection or radiation.
6. Scans used to determine eligibility (CT scan of the chest/abdomen/pelvis and MRI of the liver) must be performed within 28 days prior to randomization. An MRI of the liver is required at screening to validate that CT accurately reflects the extent of disease in the liver.
7. Patients must not have chemotherapy, radiotherapy, chemoembolization, radioembolization, or immunoembolization for their malignancy in the month prior to treatment and must have recovered from all side effects of therapeutic and diagnostic interventions except those listed in Appendix B of the study protocol. Patients receiving anti programmed cell death protein 1 (PD-1) immunotherapy such as pembrolizumab or nivolumab, or human cytotoxic T-lymphocyte antigen 4 blocking antibody such as ipilimumab should wait 8 weeks before Melphalan/HDS treatment.
8. Patients must have an ECOG PS of 0-1 at screening and on the day prior to treatment.
9. Patients must have adequate hepatic function as evidenced by total serum bilirubin ≤ 1.5 x the upper limit of normal (ULN) and a prothrombin time (PT) within 2 seconds of the upper normal limit. Aspartate aminotransferase/alanine aminotransferase (AST/ALT) must be ≤ 2.5 x ULN.
10. Patients must have a platelet count > 100,000/µL, hemoglobin ≥ 10.0 gm/dL, white blood cell count (WBC) > 2,000/uL, absolute neutrophil count (ANC) ≥ 1.5 x 109/L, and a serum creatinine ≤ 1.5 mg/dL unless the measured creatinine clearance is > 40 mL/min/1.73 m2.
11. Provided signed informed consent.

Exclusion Criteria:
1. Patients with Child-Pugh Class B or C cirrhosis or with evidence of portal hypertension by history, endoscopy, or radiologic studies.
2. Those with New York Heart Association functional classification II, III or IV active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), worsening or new-onset congestive heart failure, significant arrhythmias and severe valvular disease must be evaluated for risks of undergoing general anesthesia.
3. History or evidence of clinically significant pulmonary disease that precludes the use of general anesthesia.
4. For female patients of childbearing potential (i.e., have had a menstrual period within the past 12 months): unwilling or unable to undergo hormonal suppression to avoid menstruation during treatment.
5. For female patients of childbearing potential (i.e. have had a menstrual period within the past 12 months): a positive serum pregnancy test (β-human chorionic gonadotropin) within 7 days prior to enrollment.
6. Sexually active females of childbearing potential and sexually active males with partners of reproductive potential: unwilling or unable to use appropriate contraception from screening until at least 6 months after last administration of study treatment.
7. Lactating women are excluded from study participation.
8. Patients taking immunosuppressive drugs or who are unable to be temporarily removed from chronic anti-coagulation therapy.
9. Patients with active bacterial infections with systemic manifestations (malaise, fever, leucocytosis) are not eligible until completion of appropriate therapy.
10. Patients with severe allergic reaction to iodine contrast, which cannot be controlled by premedication with antihistamines and steroids (because a hepatic angiogram is needed for the Delcath system procedure).
11. Patients with a history of or known hypersensitivity to melphalan or the components of the Melphalan/HDS system.
12. Patients with latex allergy.
13. Patients with a history of hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia.
14. Patients with a history of bleeding disorders or evidence of intracranial abnormalities which would put them at risk for bleeding with anti-coagulation (e.g., strokes, active metastases).
15. Patients with a history of gastrinoma, hepatic vasculature incompatible with perfusion, hepatofugal flow in the portal vein or known unresolved venous shunting.
16. Known varices at risk of bleeding, including medium or large esophageal or gastric varices, or active peptic ulcer.
17. Patients with prior Whipple's procedure.
18. Patients with brain metastases or presence of other intracranial lesions at risk for bleeding by history or baseline radiologic imaging. Active infection, including Hepatitis B and Hepatitis C infection. Patients with anti-hepatitis B core antibody (HBc) positive, or hepatitis B surface antigen (HBsAg) but DNA negative are exception(s).
19. Uncontrolled endocrine disorders including diabetes mellitus, hypothyroidism, or hyperthyroidism.
20. Received any investigational agent for any indication within 30 days prior to first treatment.
21. Not recovered from side effects of prior therapy to ≤ Grade 1 (according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 4.03). Certain side effects that are unlikely to develop into serious or life-threatening events (e.g. alopecia) are allowed at > Grade 1.

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Skin Cancer
Open to Enrollment

A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects With Melanoma Who Previously Received Talimogene Laherparepvec

A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects With Melanoma Who Previously Received Talimogene Laherparepvec

Investigator:
Eric Whitman, MD
20120139

Sponsor:
Amgen, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population

Subjects who have received at least one dose of talimogene laherparepvec on an Amgen or BioVEX-sponsored clinical trial.


Inclusion Criteria:
- All subjects must provide informed consent prior to initiation of any study activities. All subjects must have received at least one dose of talimogene laherparepvec on an Amgen or BioVEX-sponsored clinical trial and must have permanently discontinued treatment on that trial.

Exclusion Criteria:

- Subjects currently receiving or planning to receive talimogene laherparepvec in the next 30 days.

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Skin Cancer
Completed

A Safety Study for MSB0010445 in Combination With Stereotactic Body Radiation in Advanced Melanoma Subjects Following Prior Treatment With Ipilimumab

This is a Phase 2a, open-label, parallel group, partly randomized dose escalation trial to assess the safety and efficacy of a low dose, an intermediate dose, and high dose MSB0010445 given by intravenous infusion to subjects with advanced (unresectable or...

Investigator:
Eric Whitman, MD

metastatic) melanoma in combination with stereotactic body radiation therapy (SBRT).

EMR 062235-005 | PHASE II

Sponsor:
EMD Serono, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
•Advanced unresectable or metastatic melanoma, previously treated with ipilimumab; with at least 1 lesion that can be irradiated; at least 1 measurable lesion outside the radiation field, different from the lesions that will be irradiated; 1 lesion that can be biopsied before treatment with SBRT and MSB0010445; 1 lesion outside the radiation field that can be biopsied while on treatment with MSB0010445; and the lesion that is biopsied at Baseline can be the lesion that will be irradiated
•The lesion that will be biopsied while on treatment should not be a lesion that has been irradiated or has been biopsied at Baseline
•Signed written informed consent
•Male and female subjects at least 18 years of age
•Life expectancy greater than or equal to (>=) 4 months
•Eastern cooperative oncology group (ECOG) performance status of 0 or 1
•Other protocol defined inclusion criteria could apply

Exclusion Criteria:
•Active central nervous system metastasis
•Prior treatment with systemic anti-melanoma treatment after ipilimumab treatment
•Treatment with ipilimumab within the 30 days before the first dose of SBRT
•Concurrent systemic therapy with steroids or other immunosuppressive agents except short-term systemic steroids for allergic reactions
•Other protocol defined exclusion criteria could apply