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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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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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908-522-2043
research@atlantichealth.org

More info:
ClinicalTrials.gov

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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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973-971-5252
research@atlantichealth.org

More info:
ClinicalTrials.gov

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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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Contact:
908-522-5768
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Brain Cancer
Closed to Enrollment

A Phase 3 Randomized Double-blind, Controlled Study of ICT-107 With Maintenance Temozolomide (TMZ) in Newly Diagnosed Glioblastoma Following Resection and Concomitant TMZ Chemoradiotherapy

ICT-107 consists of dendritic cells, prepared from autologous mononuclear cells that are pulsed with six synthetic peptides that were derived from tumor associated antigens (TAA) present on glioblastoma tumor cells. This is a Phase 3 study to evaluate ICT-107...

Investigator:
Kurt Jaeckle, MD

in patients with newly diagnosed glioblastoma. Subjects will be randomized to receive standard of care chemoradiation (temozolomide (TMZ) with either ICT-107 or a blinded control. Reinfusion with the pulsed dendritic cells should stimulate cytotoxic T cells to specifically target glioblastoma tumour cells.

ICT-107-301 | PHASE III

Sponsor:
ImmunoCellular Therapeutics, 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. Subjects must understand and sign the study specific informed consent
2. Subjects must be in primary remission
3. Subjects should have < 1 cm3 disease by MRI within the previous 4 weeks (by central read)
4. Subjects must be HLA-A2 positive by central lab
5. Subjects must have adequate renal, hepatic and bone marrow function based on screening laboratory assessments. Baseline hematologic studies and chemistry and coagulation profiles must meet the following criteria:
a. Hemoglobin (Hgb) > 8 g/dL
b. Absolute Neutrophil Count (ANC) > 1000/mm3
c. Platelet count > 100,000/mm3
d. Blood Urea Nitrogen (BUN) < 30 mg/dL
e. Creatinine < 2 mg/dL
f. Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2 x upper limit of normal (ULN)
g. Prothrombin Time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6x unless therapeutically warranted
6. Subjects must use effective contraceptive methods during the study and for three months following the last dose of study product, if of reproductive age and still retain fertility potential.
7. Subjects must have at least one positive DTH skin response (more than 5 mm) to test item challenge prior to randomization.

Exclusion Criteria:
1. Subjects receiving investigational study drug for any indication or immunological-based treatment for any reason (Filgrastim may be used for prevention of severe neutropenia).
2. Subjects with glioblastoma mutated IDH by Immunohistochemistry (IHC)
3. Subjects with concurrent conditions that would jeopardize the safety of the subject or compliance with the protocol.
4. Subjects with a history of chronic or acute hepatitis C or B infection.
5. Subjects require or are likely to require more than a 2-week course of corticosteroids for intercurrent illness. Subjects must have completed the course of corticosteroids at the time of apheresis to meet eligibility.
6. Subjects have any acute infection that requires specific therapy. Acute therapy must have been completed within seven days prior to study enrollment.
7. Subjects with active other malignancy diagnosed in the past 3 years (excepting in situ tumors)
8. Subjects known to be pregnant or nursing.

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908-522-5768
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Brain Cancer
Open to Enrollment

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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Contact:
908-522-5678
research@atlantichealth.org

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ClinicalTrials.gov

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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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Contact:
908-522-5768
research@atlantichealth.org

More info:
ClinicalTrials.gov

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Brain Cancer
Open to Enrollment

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
Open to Enrollment

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
Open to Enrollment

A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer - (KEYNOTE-355)

The study will consist of two parts. In Part 1, the safety of pembrolizumab (MK-3475) in combination with one of three different chemotherapies will be assessed in the treatment of locally recurrent inoperable or metastatic triple negative breast cancer (TNBC),...

Investigator:
Bonni Guerin, MD

which has not been previously treated with chemotherapy. In Part 2, the safety and efficacy of pembrolizumab plus chemotherapy will be assessed compared to the safety and efficacy of placebo plus chemotherapy in the treatment of locally recurrent inoperable or metastatic TNBC, which has not been previously treated with chemotherapy.

MK-3475-355 | PHASE III

Sponsor:
Merck, Sharpe & Dohme, Corp.

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 locally recurrent inoperable breast cancer not previously treated with chemotherapy and which cannot be treated with curative intent OR has metastatic breast cancer not previously treated with chemotherapy.
• Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/college of American Pathologists (ASCO/CAP) guidelines.
• Has completed treatment for Stage I-III breast cancer, if indicated, and ≥6 months elapsed between the completion of treatment with curative intent (e.g., date of primary breast tumor surgery or date of last adjuvant chemotherapy administration, whichever occurred last) and first documented local or distant disease recurrence.
• Has been treated with (neo)adjuvant anthracycline, if they received systemic treatment in the (neo)adjuvant setting, unless anthracycline was contraindicated or not considered the best treatment option for the participant in the opinion of the treating physician.
• Has measurable disease based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by local radiology review.
• Has provided recently or newly obtained core or excisional biopsy from a locally recurrent inoperable or metastatic tumor lesion for central determination of TNBC status and PD-L1 expression, unless contraindicated due to site inaccessibility and/or participant safety concerns.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to the start of study drug.
• Has a life expectancy ≥12 weeks from randomization.
• Demonstrates adequate organ function, within 10 days prior to the start of study drug.
• Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days (or longer as specified by local institutional guidelines) after the last dose of study drug.
• Male participants of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days (or longer as specified by local institutional guidelines) after the last dose of study drug.

Exclusion Criteria:
• Is currently participating in a clinical study and receiving an investigational agent and/or using an investigational device, or has participated in a clinical study and received an investigational agent and/or used an investigational device within 4 weeks prior to randomization.
• Has not recovered (e.g., to ≤ Grade 1 or to baseline) from AEs due to a previously administered therapy.
• Has neuropathy ≥ Grade 2.
• Has an active autoimmune disease that has required systemic treatment in the past 2 years (e.g., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization.
• 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, and in situ cervical cancer.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable brain metastases and did not receive chemotherapy for metastatic breast cancer.
• Has active, or a history of, pneumonitis requiring treatment with steroids.
• Has active, or a history of, interstitial lung disease.
• Has a known history of active tuberculosis (TB).
• Has an active infection requiring systemic therapy.
• Has a history of Class II-IV congestive heart failure or myocardial infarction within 6 months of randomization.
• Has a known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days (or longer as specified by local institutional guidelines) after the last dose of study drug.
• Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T cell receptor (such as cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137) or has previously participated in Merck pembrolizumab (MK-3475) clinical studies.
• Has a known history of human immunodeficiency virus (HIV).
• Has known active hepatitis B or hepatitis C.
• Has received a live vaccine within 30 days prior to randomization.
• Has a known history of hypersensitivity or allergy to pembrolizumab and any of its components and/or to any of the study chemotherapies (e.g., nab-paclitaxel, paclitaxel, gemcitabine, or carboplatin) and any of their components.
• Is receiving any medication prohibited in combination with study chemotherapies as described in the respective product labels, unless medication was stopped within 7 days prior

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Breast Cancer
Open to Enrollment

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 Double-Blind Placebo Controlled Study of Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias

This randomized phase III trial studies testosterone to see how well it works compared to placebo in treating postmenopausal patients with arthralgia (joint pain) caused by anastrozole or letrozole. Testosterone may help relieve moderate or severe arthralgia...

Investigator:
Jason Incorvati, MD

associated with the use of aromatase inhibitors, such as anastrozole or letrozole.

A221102 | 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

Inclusion Criteria:
1. Age ≥ 18 years
2. Receiving anastrozole (1mg) or letrozole (2.5 mg) orally once a day, for ≥ 21 days prior to registration and plan to continue it throughout the duration of study
3. Body Mass Index (BMI) between 18 and 35 kg/m^2
4. Women who have undergone a total mastectomy or breast conserving surgery for primary breast cancer +/-chemo, +/-radiotherapy.
5. Must have BOTH ER and PR receptor-positive tumors and BOTH must be ≥26% positive. Alternatively, if ER and PR are determined by Allred score, the score needs to be 5 or higher
6. Women who are postmenopausal by surgery, radiotherapy or presence of natural amenorrhea ≥ 12 months
7. ≥ 5/10 arthralgia (in hands, wrist, knees, or hips) while being treated with anastrozole or letrozole which is felt by the patient to be caused by their aromatase inhibitor as defined in the protocol. Note: Patients may, or may not, be taking non-opioid analgesics
8. Ability to complete questionnaire(s) by themselves or with assistance
9. ECOG Performance Status (PS) 0, 1 or 2
10. Willing to provide informed written consent
11. Willing to return to an Alliance enrolling institution for follow-up
12. Willing to provide blood samples for correlative research purposes
13. Laboratory values prior to registration as defined in the protocol:
1. Creatinine ≤1.5 x ULN
2. Hemoglobin > 11 g/dL
3. WBC > 3.0
4. Platelet Count > 100,000
5. SGOT (AST) ≤ 1.5 x ULN

Exclusion Criteria:
1. Presence of residual or recurrent cancer (locally or metastatic)
2. Diabetes mellitus or glucose intolerance, defined as a fasting glucose >125 mg/dL
3. History of coronary artery disease (angina or myocardial infarction)
4. Patients on hormone replacement therapy (HRT) ≤ 4 weeks prior to registration. This includes the use of vaginal estrogen therapy.
5. Known hypersensitivity to any component of testosterone.
6. Prolonged systemic corticosteroid treatment, except for topical applications (e.g. for rash), inhaled sprays (e.g. for obstructive airway diseases), eye drops or local insertion (e.g. intra-articular). Note: Short duration (< 2 weeks) of systemic corticosteroids is allowed (e.g. for chronic obstructive pulmonary disease) but not within 30 days prior to registration.
7. Receiving any other investigational agent
8. History of a deep venous thrombosis or a thromboembolism
9. Concurrent use of the aromatase inhibitor exemestane, as it is structurally similar to an androgen
10. Concurrent radiation therapy or chemotherapy
11. Current or planned use of cyclosporine, anticoagulants, oxphenbutazone, insulin, oral or injectable vitamin D doses over 4,000IU/day, or tamoxifen

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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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Chemotherapy Management
Open to Enrollment

A Phase 2, Randomized, Open-Label Study of Infliximab and Lower Exposure Corticosteroids vs Methylprednisolone and Higher Exposure Oral Corticosteroids for the Management of Immune-Related Severe or Persistent Diarrhea in Patients Treated With Yervoy (Ipilimumab) and/or Opdivo (Nivolumab)

The purpose of this study is to compare the effects of Infliximab and oral prednisone with methylprednisolone and oral prednisone in immune related Grade 3-4 diarrhea (= 3 days) or persistent Grade 2 diarrhea (> 5 days) patients who received chemotherapy with...

Investigator:
Eric Whitman, MD

Yervoy and/or Opdivo

CA209-601 | PHASE II

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

Inclusion Criteria:
• Subjects must have melanoma or lung cancer or renal cell carcinoma and received ipilimumab or nivolumab as a single treatment or in combination
• Subject must have NCI common toxicity Grade 3-4 immune-related diarrhea for up to 3 days or persistent Grade 2 diarrhea for more than 5 days
• Subjects must be discontinued from ipilimumab or nivolumab as monotherapy or with the combination regimen
• Subjects must be permanently discontinued from any clinical trial treatment prior to enrollment

Exclusion Criteria:
• Subjects who received other anti Cytotoxic T-lymphocytic antigen (CTLA-4) (non-ipilimumab) or other anti-Programmed death-1 (PD-1) (non-nivolumab) treatment
• Subjects treated with systemic Corticosteroid (CST) within 2 weeks before randomization and subjects treated with infliximab within 7 weeks before randomization
• Subjects with known history of tuberculosis
• Subjects with immunosuppressive disease that require use of systemic steroids or immunosuppressive treatment
• Subjects allergic to infliximab, inactive components of infliximab, murine proteins and methylprednisolone

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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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Colorectal Cancer
Open to Enrollment

A Randomized Phase II Trial to Evaluate the Efficacy of Supportive Therapy With Ginseng for Patients on Treatment With Regorafenib

This is a randomized, multi-center phase II study of ginseng in colorectal cancer patients treated with regorafenib to determine if ginseng will reduce fatigue in this patient population and improve adherence to regorafenib. Ninety (90) subjects will be enrolled...

Investigator:
Angela Alistar, MD

and randomized using a 2:1 allocation, with 60 subjects enrolled in the regorafenib + ginseng group and 30 enrolled in the regorafenib + no ginseng group.

GI14-191 | PHASE II

Sponsor:
Hoosier Cancer Research Network, 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:
• Subjects must be able to understand and be willing to sign the written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization for release of personal health information. A signed informed consent form (ICF) must be appropriately obtained prior to the conduct of any trial-specific procedure. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
• Age ≥ 18 years at the time of consent.
• Life expectancy of at least 12 weeks (3 months) as determined by the treating physician.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 28 days prior to registration.
• Histological or pathologically confirmed stage IV adenocarcinoma of the colon.
• Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
• Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 2 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the treating physician or a designated associate. NOTE: Examples of adequate contraception may include but are not limited to a combination of any two of the following: use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods of contraception (condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/ film/cream/vaginal suppository); total abstinence; male/female sterilization
• All subjects must have radiographically assessable disease per RECIST v1.1 obtained by imaging within 28 days prior to registration.
• Must be able to swallow and retain oral medication.
• Subject must be deemed a suitable candidate for regorafenib as per their treating physician.

Exclusion Criteria:
• Subject should not be receiving any agent for fatigue including steroids, megace or opioids. NOTE: Subjects who have a contrast-induced allergy are allowed to receive steroids for their scans.
• Radiotherapy within 2 weeks prior to study registration. Subjects must have recovered from all therapy-related toxicities.
• Prior treatment with regorafenib.
• Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.
• Congestive heart failure > New York Heart Association (NYHA) class 2: unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), myocardial infarction less than 6 months before study registration; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted); uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
• Evidence or history of bleeding diathesis or coagulopathy.
• Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to study registration.
• Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months of study registration.
• Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 3 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (Non-invasive tumor), Tis (Carcinoma in situ) and T1 (Tumor invades lamina propria)].
• Subjects with pheochromocytoma.
• Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
• Ongoing infection > Grade 2 NCI-CTCAE v4.0.
• Metastatic brain or meningeal tumors (symptomatic or asymptomatic).
• Major surgical procedure or significant traumatic injury, as defined by the site investigator, within 28 days before study registration.
• Renal failure requiring hemo- or peritoneal dialysis
• Dehydration Grade > 2 NCI CTCAE v4 within 7 days prior to registration.
• Subjects with seizure disorder currently requiring medication.
• Persistent proteinuria ≥ Grade 3 NCI CTCAE v4.0 as defined as > 3.5 g/24 hours, measured by urine protein: creatinine ratio on a random urine sample.
• Interstitial lung disease with ongoing signs and symptoms at the time of study registration.
• Pleural effusion or ascites that causes respiratory compromise (≥ NCI CTCAE version 4.0 Grade 2 dyspnea).
• History of organ allograft (including corneal transplant).
• Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial.
• Any malabsorption condition which, in the opinion of the treating physician, will affect the absorption of any of the agents used in this study.
• Women who are pregnant or breast-feeding.
• Any condition, which, in the site investigator's opinion, makes the subject unsuitable for trial participation.
• Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
• Treatment with any investigational agent within 28 days prior to registration.

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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/3 Multicenter, Randomized, Open-Label Trial of Talimogene Laherparepvec in Combination With Pembrolizumab for the Treatment of Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

A Phase 1b/3 Multicenter, Randomized, Open-label Trial of Talimogene Laherparepvec in combination with Pembrolizumab for the Treatment of Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck.

Investigator:
Eric Whitman, MD
20130232 | PHASE I

Sponsor:
Amgen, Inc.

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

Inclusion Criteria:
• Subject age ≥ 18 years at the time of informed consent.
• Histologically confirmed diagnosis of metastatic or recurrent SCCHN.
• Disease must be unsuitable for curative surgical resection and must not be amenable to curative radiotherapy.
• Disease must have progressed after treatment with a platinum-containing regimen and should be defined as either one of the following:
• Recurrence/progression within 6 months of prior multimodal therapy using platinum
• Disease progression or recurrence after prior platinum therapy in the recurrent or metastatic setting
• Subject must be candidate for intralesional therapy administration.
• Subject must have radiographically measurable disease per RECIST 1.1 ECOG performance status of 0 or 1.
• Adequate organ function determined within 14 days prior to enrollment.
• Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to enrollment.
• Other Inclusion Criteria May Apply

Exclusion Criteria:
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Primary nasopharyngeal carcinoma.
• Subject at risk of airway compromise in the event of post injection tumor swelling/inflammation based on investigator judgment
• Previous treatment with 3 or more systemic regimens given for recurrent and/or History of other malignancy within the past 3 years with the following exceptions:
• Malignancy treated with curative intent and with no known active disease present and has not received chemotherapy for ≤ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician
• Adequately treated non-melanoma skin cancer without evidence of disease at the time of enrollment
• Adequately treated cervical carcinoma in situ without evidence of disease at the time of enrollment
• Adequately treated breast ductal carcinoma in situ without evidence of disease at the time of enrollment
• Prostatic intraepithelial neoplasia without evidence of prostate cancer at the time of enrollment
• Adequately treated superficial or in situ carcinoma of the bladder without evidence of disease at the time of enrollment
• Evidence of active, non-infectious pneumonitis
• History of interstitial lung disease (ILD)
• Prior therapy with talimogene laherparepvec, pembrolizumab, other anti-PD-1, any other antibody or drug specifically targeting T-cell co-stimulation or immune check point pathway
• Prior enrollment and initiation of treatment on any pembrolizumab trial
• History or evidence of active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy is not considered a form of systemic treatment
• Evidence of clinically significant immunosuppression Active herpetic skin lesions or prior complications of herpetic infection.
• Requires intermittent or chronic treatment with an antiherpetic drug other than intermittent topical use.
• Prior chemotherapy, radiotherapy, biological cancer therapy or major surgery within 28 days prior to enrollment or has not recovered to CTCAE grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment.
• Expected to require other cancer therapy while on study with the exception of local palliative radiation treatment to the site of bone and other metastasis.
• Known human immunodeficiency virus (HIV) disease. Has acute or chronic active hepatitis B or C virus infection or received treatment with nucleotide analogs such as those used in the treatment of hepatitis B virus, ribavirin, or interferon alpha within 12 weeks of initiation of study treatment.

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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 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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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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Liver Cancer
New

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 Master Protocol of Phase 1/2 Studies of Nivolumab in Advanced NSCLC Using Nivolumab as Maintenance After Induction Chemotherapy or as First-line Treatment Alone or in Combination With Standard of Care Therapies (CheckMate 370: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 370)

The purpose of this study is to determine whether nivolumab monotherapy or in combination with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR) without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.

Investigator:
Dennis Lowenthal, MD

The purpose of this study is to determine whether nivolumab monotherapy or in combination with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR) without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.

CA209-370 | PHASE I/II

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

Inclusion Criteria:
• Histologically confirmed locally advanced or stage IV NSCLC
• Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
• Tumor tissue sections must be available for biomarker evaluation

Exclusion Criteria:
• Untreated or active/progressing Central Nervous system (CNS) metastases
• Active, known or suspected autoimmune disease
• Known history of testing positive for HIV or AIDS
• Active or chronic infection of hepatitis B virus or hepatitis C

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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 Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC)

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients...

Investigator:
Dennis Lowenthal, MD

with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC

MYSTIC | PHASE III

Sponsor:
AstraZeneca

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 150 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:

For inclusion in the study, patients should fulfill the following criteria:
• Aged at least 18 years
• Documented evidence of Stage IV NSCLC
• No activating EGFR mutation or ALK rearrangement
• No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC
• World Health Organization (WHO) Performance Status of 0 or 1

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are fulfilled:
• Mixed small-cell lung cancer and NSCLC histology or not otherwise specified (NSCLC NOS)
• Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
• Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines
• Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)

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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

S1400 Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study "Master Protocol". The type of cancer...

Investigator:
Dennis Lowenthal, MD

trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a "non-match" sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

S1400 | PHASE II/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

Inclusion Criteria:
• SCREENING REGISTRATION:
• Patients must have pathologically proven squamous cell non-small cell lung cancer (NSCLC) confirmed by tumor biopsy and/or fine-needle aspiration; disease must be either advanced, incurable stage IIIB or stage IV NSCLC; the primary diagnosis of SCCA should be established using the current World Health Organization (WHO)/International Association for the Study of Lung Cancer (IASLC)-classification of Thoracic Malignancies; the diagnosis is based on hematoxylin and eosin (H&E) stained slides with or without specific defined immunohistochemistry (IHC) characteristic (p40/p63 positive, transcription termination factor [TTF1] negative) if required for diagnosis; mixed histologies will be allowed provided that they contain >= 50% of the squamous component
• Patients must have progressed after receiving exactly one front-line platinum containing metastatic chemotherapy regimen
• Patients must have adequate tumor tissue available (defined as >= 20% tumor cells as confirmed by the treating institution's local pathologist); patients must agree to have this tissue submitted to Foundation Medicine for common broad platform Clinical Laboratory Improvement Amendments (CLIA) biomarker profiling; if archival tumor is used either a tumor block or at a minimum 12 formalin-fixed paraffin-embedded (FFPE) slides 4-5 microns thick are required, but 20 slides are strongly recommended; in the event that patient's archival tumor material is derived from a fine needle aspirate and the tumor material from fine needle aspirate or from core needle biopsy is exhausted a new fresh tumor biopsy will be obtained and will be formalin fixed and paraffin-embedded
• Patients must not have a known epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion; in addition, patients whose biomarker profiling results indicate the presence of an EGFR mutation or ALK fusion will be notified that they are not eligible for any of the sub-studies
• Patients must have Zubrod performance status =< 2 documented within 28 days prior to screening registration
• Patients must also be offered participation in banking for future use of specimens
• Patients must be willing to provide prior smoking history
• Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
• As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

• SUB-STUDY ASSIGNMENT:
• Patients whose biomarker profiling results indicate the presence of an EGFR mutation or echinoderm microtubule-associated protein-like 4 (EML4)/ALK fusion are not eligible
• Patients must be registered to the assigned sub-study within 28 calendar days of receiving sub-study assignment from the statistical center
• Patients must have measurable disease, documented by computed tomography (CT) or magnetic resonance imaging (MRI); the CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality; if patient has measurable disease it must assessed within 28 days prior to sub-study treatment arm randomization; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form; patients with active new disease growth in previously irradiated site are eligible
• Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study treatment arm randomization; patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 28 days following treatment, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 14 days prior to randomization
• Patients must have progressed after receiving exactly one front-line platinum containing metastatic chemotherapy regimen; patients must not have received any prior systemic chemotherapy or investigational drug within 21 days prior to sub-study treatment arm randomization; patients must have recovered (=< grade 1) from any side effects of prior therapy; localized palliative radiotherapy >= 14 days is allowed
• Patient must have fully recovered from the effects of prior surgery prior to sub-study treatment arm randomization
• Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
• Absolute neutrophil count (ANC) >= 1,500/mcl obtained within 28 days prior to sub-study treatment arm randomization
• Platelet count >= 100,000 mcl obtained within 28 days prior to sub-study treatment arm randomization
• Hemoglobin >= 9 g/dL obtained within 28 days prior to sub-study treatment arm randomization
• Serum bilirubin =< 2 X institutional upper limit of normal (IULN) within 28 days prior to sub-study treatment arm randomization
• Either serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transferase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x IULN within 28 days prior to sub-study treatment arm randomization (if both SGOT and SGPT are done, both must be =< 2 IULN)
• For patients with liver metastases, bilirubin and either SGOT and SGPT must be =< 5 x IULN
• Serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50 cc/min using the following Cockroft-Gault Formula within 28 days prior to sub-study treatment arm randomization
• Patients must have Zubrod performance status =< 2 documented within 28 days prior to sub-study treatment arm randomization
• 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, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
• Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection
• Patients must not have a known history of human immunodeficiency virus (HIV) seropositivity
• Prestudy history and physical must be obtained within 28 days prior to sub-study treatment arm randomization
• 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, or any other cancer from which the patient has been disease free for five years
• 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

S1400A:
• Patients must not have any prior exposure to immunotherapy such as, but not limited to other anti-cytotoxic T lymphocyte antigen 4 (CTLA-4), anti-programmed cell death (PD)-1, or anti-PD-L1 antibodies excluding vaccines within 28 days prior to sub-study treatment arm randomization
• Patients must not have received or be planning to receive any anti-cancer therapy whether chemotherapy, or biologic therapy, therefore receipt of the last dose of anti-cancer therapy, (chemotherapy, endocrine therapy, targeted therapy, biologic therapy, or tumor embolization) > 21 days prior to randomization (> 14 days prior to randomization for patients who have received prior TKIs [e.g. erlotinib, gefitinib, or crizotinib] and > 42 days for nitrosoureas or mitomycin-c)
• Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable; patients must not have received or be planning to receive any immunosuppressive medication within 28 days prior to sub-study treatment arm randomization, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
• Patients must not have any active or prior documented autoimmune or inflammatory disease (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease; Wegner syndrome; Hashimoto syndrome) within 3 years prior to sub-study treatment arm randomization; patients with vitiligo, alopecia, Grave's disease, or psoriasis not requiring systemic treatment (within the past 3 years) are not excluded
• Patients must not have any history of primary immunodeficiency
• Patients must not have any prior grade >= 3 immune-related adverse event (irAE) or any unresolved irAE > grade 1
• Patients must not have any history of organ transplant that requires use of immunosuppressives
• Patients must not have any known allergy or reaction to any component of the MEDI4736 formulation
• Patients must not have a known history of tuberculosis
• Patients must not have received a live attenuated vaccination within 28 days prior to sub-study treatment arm randomization
• Patients must not have known HIV, hepatitis B or C positivity

S1400B:
• Hemoglobin A1c (HbA1c) < 7% obtained within 28 days prior to sub-study treatment arm randomization
• Fasting glucose < 125 mg/dl obtained within 28 days prior to sub-study treatment arm randomization
• Patients must not have Type 1 or 2 diabetes which requires insulin
• Patients must not have active or a history of small or large intestine inflammation such as Crohn's disease or ulcerative colitis
• Patients must not require daily supplemental oxygen
• 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 GDC-0032 (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
• Patients must not be taking, nor plan to take while on protocol treatment and for 14 days post the last dose of study treatment, drugs, herbal supplements or foods that are known to be strong/moderate cytochrome p450, family 3, subfamily A, polypeptide 4 (CYP3A4) substrates
• Patients must not have received prior treatment of docetaxel as part of frontline platinum-containing chemotherapy (S1400B)

S1400C:
• Patients must not be taking within 7 days prior to sub-study treatment arm randomization, nor plan to take while on protocol treatment, CYP3A4 inhibitors and/or strong CYP3A4 inducers; moderate inhibitors or inducers of isoenzyme CYP3A4 should be avoided, but if necessary can be used with caution
• Patients must not be taking within 7 days prior to sub-study treatment arm randomization, nor plan to take while on protocol treatment drugs that are known to prolong the QT interval
• Patients must not have QTc > 480msec (based on the mean value of the triplicate electrocardiograms [ECGs]), family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes
• Patients must not have uncontrolled electrolyte disorders which can compound the effects of a QTc-prolonging drug (eg, hypocalcemia, hypokalemia, hypomagnesemia)
• Patients must be able to take oral medications; patient may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of palbociclib (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
• Patients must not have received prior treatment of docetaxel as part of frontline platinum-containing chemotherapy (S1400C)

S1400D:
• Patients must be >= 25 years of age (skeleton maturation is complete)
• Patients must not be taking, nor plan to take while on protocol treatment and for 14 days after the last dose of study treatment drugs, herbal supplements and/or foods known to modulate CYP3A4 or cytochrome p450, family 2, subfamily D, polypeptide 6 (CYP2D6) enzyme activity and drugs that are known to be CYP3A4 substrates
• Patients must not have received Nitrosourea or mitomycin C within 42 days prior to sub-study treatment arm randomization
• Patients must not have had any prior exposure to any agent with FGFR inhibition as its primary pharmacology
• Patients must not have a mean resting corrected QT interval (QTc) > 450 msec obtained from 3 consecutive electrocardiograms (ECGs); any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block); nor any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, 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
• Patients must be able to take oral medications; patient may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of AZD4547 (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
• Patients must not have a history of hypersensitivity to active or inactive excipients of AZD4547 or drugs with a similar chemical structure or class to AZD4547

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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

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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M
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Multiple Myeloma
Open to Enrollment

A Phase III Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (KEYNOTE 183)

The purpose of this study is to compare the efficacy of pomalidomide and low dose dexamethasone with pembrolizumab (MK-3475) to that of pomalidomide and low dose dexamethasone without pembrolizumab in terms of Progression-Free Survival (PFS) in participants...

Investigator:
Neil Morganstein, MD

with refractory or relapsed and refractory multiple myeloma (rrMM) who have undergone at least 2 lines of prior treatment.

MK-3475-183 | PHASE III

Sponsor:
Merck, Sharpe & Dohme, Corp.

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 a confirmed diagnosis of active multiple myeloma and measurable disease
• Must have undergone prior treatment with ≥2 treatment lines of anti-myeloma therapy and must have failed last line of treatment (refractory to last line of treatment)
• Prior anti-myeloma treatments must have included an immunomodulatory drug (IMiD) AND proteasome inhibitor alone or in combination and participant must have failed therapy with an IMiD OR proteasome inhibitor
• Has performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
• Female participants of childbearing potential must have 2 negative urine human chorionic gonadotropin tests within 10 to 14 days and within 24 hours prior to receiving study medication
• Female participants of childbearing potential and male participants must agree to use adequate contraception 28 days prior to study start and continuing for up to 28 days after the last dose of pomalidomide (or 120 days after the last dose of pembrolizumab)

Exclusion Criteria:
• Has had prior anti-myeloma therapy within 2 weeks prior to study start and has not recovered (i.e., ≤ Grade 1 or at Baseline) from adverse events due to a previously administered agent
• Has undergone prior allogeneic hematopoetic stem cell transplantation within the last 5 years. (Participants who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of Graft versus Host Disease [GVHD]).
• Has received autologous stem cell transplant (auto-SCT) within 12 weeks before the first infusion or is planning for or is eligible for auto-SCT
• Has received previous therapy with pomalidomide
• Has peripheral neuropathy ≥ Grade 2
• Has a known additional malignancy that is progressing or requires active treatment within the last 5 years (except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy)
• Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
• Has received prior therapy with an anti-programmed cell death 1 receptor (anti-PD-1), antiprogrammed death-ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways)
• Is pregnant or breast-feeding

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Multiple Myeloma
Open to Enrollment

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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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 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The focus of this study is to evaluate the efficacy, safety, and tolerability of veliparib in women with previously untreated, Stage III or IV, high-grade serous, epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Investigator:
Paul Heller, MD
M13-694 | PHASE III

Sponsor:
AbbVie, Inc.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 99 Years
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:
1. Histologic diagnosis of International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, with the appropriate tissue available for histologic evaluation.
2. High-grade serous adenocarcinoma
3. Willing to undergo testing for gBRCA.
4. Adequate hematologic, renal, and hepatic function.
5. Neuropathy (sensory and motor) less than or equal to Grade 1.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
7. Participants who undergo primary cytoreductive surgery must be entered between 1 and 12 weeks after surgery. Participants undergoing interval surgery must have a tumor sample confirming the histological diagnosis prior to enrollment.
8. Participants with measurable disease and non-measurable disease are eligible. Participants may or may not have cancer-related symptoms.
9. Participant has one of the following available for PD analyses including somatic BRCA testing: Archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue; or tumor tissue biopsy collected prior to Cycle 1 Day 1.

Exclusion Criteria:
1. Endometrioid adenocarcinoma, carcinosarcoma, undifferentiated carcinoma, mixed epithelial adenocarcinoma, adenocarcinoma not otherwise specified, mucinous adenocarcinoma, clear cell adenocarcinoma, low-grade serous adenocarcinoma, or malignant Brenner's tumor.
2. Participants with synchronous primary endometrial cancer, or a past history of endometrial cancer unless all of the following conditions are met: endometrial cancer stage not greater than IA, no vascular or lymphatic invasion, no poorly differentiated subtypes including serous, clear cell, or other FIGO grade 3 lesions.
3. Participants with any evidence of other invasive malignancy being present within the last 3 years (with the exception of non-melanoma skin cancer). Participants are also excluded if their previous cancer treatment contraindicates this protocol's therapy.
4. Received prior radiotherapy to any portion of the abdominal cavity or pelvis.
5. Received prior chemotherapy for any abdominal or pelvic tumor.
6. Clinically significant uncontrolled condition(s).
7. Known history of allergic reaction to Cremophor-paclitaxel, carboplatin, Azo-Colourant Tartrazine (also known as FD&C Yellow 5 or E102), Azo-Colourant Orange Yellow-S (also known as FD&C Yellow 6 or E110) or known contraindications to any study supplied drug.
8. History or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) within 6 months of Cycle 1 Day 1.

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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 Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physician's Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian Cancer in Patients Carrying Germline BRCA1/2 Mutations

Comparison of olaparib vs. physician's choice of single agent standard of care non-platinum based chemotherapy in patients with germline Breast Cancer susceptibility gene (gBRCA) mutated ovarian cancer who have progressed at least 6 months after the last platinum...

Investigator:
Nana Tchabo, MD

based chemotherapy. Patient should have received at least 2 prior lines of platinum based chemotherapy. The aim of the study is to assess the efficacy and safety of olaparib tablets.

SOLO3 | PHASE III

Sponsor:
AstraZeneca

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

Inclusion Criteria:
- Patients must be ≥ 18 years of age
- Patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer
- Documented germline mutation in Breast Cancer susceptibility genes: BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)
- At least one lesion that can be accurately assessed at baseline by CT/MRI and is suitable for repeated assessment.
- Patients must have received at least 2 prior platinum based lines of chemotherapy - Patients must be partially platinum sensitive or platinum sensitive
- Patients must be suitable to start treatment with single agent chemotherapy based on physician's choice
- Patients must have normal organ and bone marrow function measured within 28 days of randomisation,
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patients must have a life expectancy ≥ 16 weeks
- Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing.

Exclusion Criteria:
- BRCA 1 and/or BRCA2 mutations that are considered to be non detrimental
- Exposure to any investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation
- Any previous treatment with a Polyadenosine 5'diphosphoribose polymerisation (PARP) inhibitor, including olaparib.
- Patients who have platinum resistant or refractory disease
- Patients receiving any systemic chemotherapy within 3 weeks prior to first dose of study treatment
- Previous single agent exposure to the selected chemotherapy regimen for randomisation. - Prior malignancy in the last 5 years, unless curatively treated and recurrence free (few exceptions apply).

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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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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 Double-Blinded, Placebo-Controlled, Randomized Phase II Study of Enzalutamide With or Without the PI3 Kinase/mTOR Inhibitor LY3023414 in Men With Metastatic Castration Resistant Prostate Cancer

The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as LY3023414 in combination with enzalutamide in men with prostate cancer.

Investigator:
David Chaikin, MD
I6A-MC-CBBD | PHASE II

Sponsor:
Eli Lilly and Company

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.
• Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan.
• Prostate cancer progression documented by PSA and/or radiographic progression according to prostate cancer working group 2 (PCWG2).
• Prior abiraterone treatment completed at least 4 weeks prior to cycle 1 day 1.
• Surgically or medically castrated, with testosterone levels of < 50 nanograms/deciliter.
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
• Ability to swallow the study drugs whole.
• Adequate hematologic function.
• Adequate coagulation parameters, defined as international normalization ratio (INR) ≤ 2.
• Availability of tumor tissue from any time since diagnosis of prostate cancer disease. If no tumor samples are available the participant might still be eligible following discussion between the investigator and the medical monitor.

Exclusion Criteria:
• Prior cytotoxic chemotherapy, immunotherapy, a PI3K/AKT/mTOR agent (including TORC1 and TORC2 inhibitors), or RA 223 dichloride for the treatment of castration resistant prostate cancer (CRPC). Participants may have received docetaxel in the hormone-sensitive setting.
• Prior investigational new generation potent anti-androgen therapy (such as ARN 509).
• Prior treatment with enzalutamide.
• Pathological finding consistent with small cell carcinoma of the prostate.
• Prior systemic treatment with an azole drug (fluconazole, itraconazole) within 4 weeks of cycle 1 day 1.
• Known brain metastasis.
• History of (a) seizure or any condition that may predispose to seizure (prior cortical stroke or significant brain trauma); (b) loss of consciousness or transient ischemic attack within 12 months prior to day 1 of cycle 1.
• Uncontrolled hypertension (systolic blood pressure [BP] ≥ 160 millimeters of mercury [mmHg] or diastolic BP ≥ 95 mmHg).
• Have serious pre-existing medical conditions (at the discretion of the investigator).
• Have known acute or chronic leukemia or current hematologic malignancies that, in the judgment of the investigator and sponsor, may affect the interpretation of results.
• Have insulin-dependent diabetes mellitus. Participants with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetics as documented by hemoglobin A1c <7%.
• Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy (e.g. ulcerative disease, uncontrolled nausea, vomiting, grade ≥2 diarrhea, and malabsorption syndrome).
• Have a history of New York Heart Association (NYHA) Class ≥3, QTc interval > 450 milliseconds (ms) on screening electrocardiogram (ECG) per Friderica's formula, unstable angina, or myocardial infarction (MI) in 6 months prior to study drug administration.
• Clinically significant electrolyte imbalance ≥ grade 2.
• Currently receiving treatment with therapeutic doses of warfarin sodium.
• Have initiated treatment with bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents (e.g. denosumab) ≤28 days prior to day 1 of cycle 1.
• Concurrent serious infections requiring parenteral antibiotic therapy.
• Have a second primary malignancy that in the judgment of the investigator and medical monitor may affect the interpretation of results.
• Have an active, known fungal, bacterial, and/or known viral infection.

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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 Multicenter, Two-arm, Prospective, Observational Study to Characterize the Tolerability of Treatment With Enzalutamide or Abiraterone Acetate (With Prednisone) for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

The purpose of this study is to characterize the tolerability profiles of enzalutamide and abiraterone acetate (with prednisone) -with specific focus on central nervous system (CNS) tolerability-and quality of life (QoL) after approximately 2 months of participants...

Investigator:
Adam Berman, MD

starting treatment with one of these agents for metastatic castration-resistant prostate cancer (mCRPC).

212082PCR4038

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
Sampling Method: Non-Probability Sample

Study Population:
Participants who have a confirmed metastatic adenocarcinoma of the prostate will receive either enzalutamide or abiraterone acetate with prednisone for the treatment at the discretion of their treatment physician and in accordance with clinical practice.

Inclusion Criteria:
• Male 18 years of age or older
• Have confirmed metastatic adenocarcinoma of the prostate
• Are starting treatment with enzalutamide or abiraterone acetate (with prednisone) for metastatic castration-resistant prostate cancer (mCRPC) at the full recommended dose per each drug's respective prescribing information (PI)
• Have an Eastern Cooperative Oncology Group Performance Status score of 0 or 1
• Sign written informed consent

Exclusion Criteria:
• Have a pre-existing central nervous system (CNS) condition (including, but not limited to, history of stroke or dementia) that, in the participating physician's judgment, would preclude participation in the study
• Have known mental illness including, but not limited to, major depressive disorder, general anxiety disorder, or bipolar disorder that, in the participating physician's opinion, could significantly confound the patient-reported outcome (PRO) assessments
• Have a history of or ongoing seizure disorder
• Have severe hepatic impairment (Child-Pugh Class C)
• Have an active infection (example, human immunodeficiency virus [HIV], viral hepatitis) or other medical condition that would contraindicate the use of prednisone/prednisolone (systemic glucocorticoid)
• Have known alcohol or other substance abuse disorder
• Are routinely taking medication-including, but not limited to, over-the-counter medications, supplements, medical marijuana or prescription pain medication-that is known to cause mental confusion or sedation or are using any of the medications
• Are routinely taking systemic glucocorticoids (example, prednisone, prednisolone, dexamethasone) at a dosage higher than the equivalent of prednisone 10 milligram (mg) daily
• Are currently using or have previously used chemotherapy for any cancer including mCRPC
• Are concurrently using any first-generation androgen-receptor blocker (example, bicalutamide, flutamide, nilutamide) for mCRPC
• Have previously taken enzalutamide or abiraterone acetate with prednisone
• Are not capable of completing tests using a computerized system or completing a participant survey

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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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Skin Cancer
Open to Enrollment

A Phase 1, Open-Label Clinical Trial Evaluating the Safety, Tolerability and Immunogenicity of Intradermally Administered ID-LV305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1

This is a Phase 1 multi-center study to evaluate the clinical safety and immune response of ID-LV305 when injected intradermally in patients with advanced cancer. ID-LV305 is a novel immunotherapy agent designed to target dendritic cells and stimulate the...

Investigator:
Eric Whitman, MD

body's immune system to fight the spread and growth of cancer for patients whose tumors express the NY-ESO-1 protein. Patients with melanoma, sarcoma, ovarian cancer, or non-small cell lung cancer that express NY-ESO-1 may be considered for the trial. Selected sites will be evaluating ID-LV305 with Pembrolizumab for patients with melanoma who have inadequately responded to anti-PD-1 therapy.

ID-LV305-2013-01 | PHASE I

Sponsor:
Immune Design Corp.

Inclusion & Exclusion Criteria:
Ages Eligible for Study: 18 Years to 80 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Locally advanced, relapsed, and/or metastatic cancer with low or minimal tumor burden which may or may not be measurable
• Tumor histology consistent with one of the following: breast cancer, melanoma, non-small cell lung cancer (NSCLC), ovarian cancer (including fallopian tube carcinoma) or sarcoma
• Tumor specimen positive for NY-ESO-1 expression by IHC and/or RT-PCR
• If ovarian cancer, cancer antigen 125 (CA-125) must be ≥ 40 U/mL (unless patient has measurable disease which cannot be followed by CA-125), or if melanoma, LDH must be ≤ ULN
• Inadequate response, relapse, and/or unacceptable toxicity with one or more prior systemic, surgical, or radiation cancer therapies, except patients with NSCLC and breast cancer who must have experienced either an inadequate response and/or unacceptable toxicity with two or more prior systemic, surgical, or radiation cancer therapies
• ≥ 18 years of age
• Life expectancy of ≥ 6 months per the investigator
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• ECG without evidence of clinically significant arrhythmia or ischemia
• If female of childbearing potential (FCBP), willing to undergo pregnancy testing and agrees to use at least one highly effective or two effective contraceptive methods during the dosing period and for three months after last ID-LV305 injection
• If male and sexually active with a FCBP, must agree to use highly effective contraception such as latex condom during the dosing period and for three months after last ID-LV305 injection

Exclusion Criteria:
• Investigational therapy within 3 weeks prior to ID-LV305 dosing
• Prior administration of other NY-ESO-1-targeting immunotherapeutics
• Significant immunosuppression from:
a. Concurrent, recent (≤ 4 weeks ago) or anticipated treatment with systemic corticosteroids at any dose, or
b. Other immunosuppressive medications such as methotrexate, cyclosporine, azathioprine (antihistamines, non-steroidal anti- inflammatory drugs and aspirin permitted) or conditions such as common variable hypogammaglobulinemia or exposures such as large field radiotherapy
• Cancer therapies, including chemotherapy, radiation, biologics or kinase inhibitors, G-CSF or GM-CSF within 3 weeks prior to the first scheduled ID-LV305 dosing
• Psychiatric, other medical illness or other condition that in the opinion of the PI prevents compliance with study procedures or ability to provide valid informed consent
• Significant autoimmune disease with the exception of alopecia, vitiligo, hypothyroidism or other conditions that have never been clinically active or were transient and have completely resolved and require no ongoing therapy
• Myocardial infarction within 6 months of study initiation, active cardiac ischemia or New York Heart Association (NYHA) Grade III or IV heart failure
• Inadequate organ function including:
a. Marrow: Peripheral blood leukocyte count (WBC) < 3000/mm3, absolute neutrophils count ≤ 1500/mm3, platelets < 75000/mm3, or hemoglobin < 10 gm/dL
b. Hepatic: alanine aminotransferase (ALT), and aspartate aminotransferase (AST) > 2.5 x ULN, total serum bilirubin > 1.5 x ULN (patients with Gilbert's Disease may be included if their total bilirubin is ≤ 3.0 mg/dL)
c. Renal: Creatinine > 1.5x ULN
d. Other: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULN
• History of other cancer within 3 years (except non-melanoma cutaneous malignancies and cervical carcinoma in situ)
• Active tuberculosis or recent (< 2 week ago) clinically significant infection or evidence of active hepatitis B, hepatitis C or HIV infection
• Uveal melanoma
• Brain metastases considered unstable as:
a. Without confirmed stability over 60 days in patients previously treated with prior surgery or radiation; OR
b. Associated with symptoms and/or findings; OR
c. Requiring corticosteroids or anticonvulsants in the prior 60 days
• Pregnancy or nursing

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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, 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
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A Phase III, Double-Blinded, Randomized, Placebo-Controlled Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFV600 Mutation-Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

This is a Phase III, double-blinded, placebo-controlled, randomized, multicenter study designed to evaluate the efficacy, safety, and pharmacokinetics of combination of atezolizumab (ATZ), cobimetinib and vemurafenib compared with combination of ATZ placebo,...

Investigator:
Eric Whitman, MD

cobimetinib and vemurafenib in participants with previously untreated BRAFv600 mutation-positive metastatic or unresectable locally advanced melanoma.

CO39262 | PHASE III

Sponsor:
Genentech, 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:
• Age greater than or equal to (>/=) 18 years
• Females of child bearing potential and males with female partners must and use of contraceptive methods with a failure rate of less than or equal to (• Histologically confirmed Stage IV (metastatic) or unresectable Stage IIIc (locally advanced) melanoma
• Naive to prior systemic anti-cancer therapy for melanoma (example: chemotherapy, hormonal therapy, targeted therapy, immunotherapy, or other biologic therapies) except adjuvant treatment with interferon (IFN), interleukin (IL)-2, or vaccine therapies or herbal therapies
• Documentation of BRAFv600 mutation-positive status in melanoma tumor tissue (archival or newly obtained) through use of a clinical mutation test approved by the local health authority
• Eastern Cooperative Oncology Group Performance (ECOG) Status of 0 or 1
• Measurable disease according to RECIST v1.1
• Life expectancy >/=18 weeks
• For participants not receiving therapeutic anticoagulation: International normalized ratio (INR) or activated partial thromboplastin time (aPTT) less than or equal to (• For participants receiving therapeutic anticoagulation: stable anticoagulant regimen and stable INR during the 28 days immediately preceding initiation of study treatment

Exclusion Criteria:

Cancer-Related Exclusion Criteria:
• Major surgical procedure within 4 weeks prior study treatment initiation
• Traumatic injury or palliative radiotherapy within 2 weeks prior study treatment initiation
• Active malignancy (other than BRAFv600 mutation-positive melanoma) or malignancy within 3 years prior to screening, with the exception of resected melanoma, resected basal cell carcinoma (BCC), resected cutaneous squamous cell carcinoma (SCC), resected carcinoma in situ of the cervix, resected carcinoma in situ of the breast, in situ prostate cancer, limited-stage bladder cancer, or other curatively treated malignancies from which the participant has been disease-free for at least 3 years

Ocular Exclusion Criteria:
• History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, central serous chorioretinopathy, retinal vein occlusion (RVO), or neovascular macular degeneration

Cardiac Exclusion Criteria:
• History of clinically significant cardiac dysfunction
• Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal or below 50%

Central Nervous System (CNS) Exclusion Criteria:
• Untreated or actively progressing CNS lesions (carcinomatous meningitis)
• History of metastases to brain stem, midbrain, pons, or medulla, or within 10 millimeter (mm) of the optic apparatus (optic nerves and chiasm); or leptomeningeal metastatic disease; or intracranial hemorrhage

Additional Exclusion Criteria:
• Current severe, uncontrolled systemic disease (including, but not limited to, clinically significant cardiovascular, pulmonary, or renal disease) other than cancer
• History of malabsorption or other clinically significant metabolic dysfunction
• Pregnant or breastfeeding, or intending to become pregnant during the study
• Prior allogeneic stem cell or solid organ transplantation
• History of idiopathic pulmonary fibrosis, organizing pneumonia (example: bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
• History of autoimmune disease
• Known clinically significant liver disease, inherited liver disease and active viral disease
• Active tuberculosis
• Treatment with therapeutic oral or intravenous (IV) antibiotics; or with a live, attenuated vaccine; or systemic immunosuppressive medication
• Known hypersensitivity to biopharmaceutical agents produced in Chinese hamster ovary cells or any component of the atezolizumab, cobimetinib, or vemurafenib formulations

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Skin Cancer
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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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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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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
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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
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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
Open to Enrollment

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

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Skin Cancer
Open to Enrollment

A US Multi-Site Observational Study in Patients with Unresectable and Metastatic Melanoma: The OPTIMIzE Study

This study evaluates the different patterns of care for patients who have unresectable or metastatic melanoma. The dosing, duration, regimen, indication, and treatments will be observed. The survival rate of these patients will also be observed.

Investigator:
Eric Whitman, MD
CA209-357

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: Non-Probability Sample

Study Population:
Patients diagnosed with histologically-confirmed unresectable stage III or stage IV melanoma, (including mucosal, uveal, acral-lentiginous, leptomeningeal disease). Patients can be treatment-naïve or previously treated for unresectable or metastatic melanoma.

Inclusion Criteria:
Prospective cohort patients:
• Diagnosis date must occur on or after March 24, 2011 (date of ipilimumab approval in US)
• Diagnosis of stage III (unresectable) or stage IV melanoma (includes mucosal, uveal acral-lentiginous, leptomeningeal disease)
• Age ≥ 18 years at time of entry into study
• Patients must be actively receiving or scheduled to receive systemic treatment (any line, eg, first, second, third line [including investigational drugs]).
◦ For patients initiating new treatment, treatment must be started within 28 days after signing informed consent.
◦ For patients currently receiving treatment, patients must enroll within the first 21 days of starting new treatment
Retrospective cohort patients:
• Patients with diagnosis of confirmed unresectable stage III or stage IV melanoma (including mucosal, uveal, acral-lentiginous, leptomeningeal disease)
• Age ≥ 18 years at time of unresectable or metastatic melanoma diagnosis
• Initiated therapy for unresectable or metastatic melanoma within 4 years prior to approval of ipilimumab (first immune checkpoint inhibitor therapy approved in US)
◦ March 25, 2007 - March 24, 2011
• One year of follow-up data is required from date of therapy initiation, if a patient passed away within the one year of follow-up; such patients are still eligible and the date of death will be collected.
a.If retrospective patients have at least one year of follow-up data and are then treated with immuno-oncology, immune checkpoint inhibitor therapy, or targeted therapy, these patients will be analyzed separately.

Exclusion Criteria:
Prospective patients:
• Patients participating in a clinical study that does not allow enrollment into a non interventional study or clinical studies in which the investigational treatment is blinded
• Patients who started new treatment > 21 days
• Patients who enrolled in study but did not initiate treatment before 28 days
• Patients with current malignancies (except non-melanoma skin cancer and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) that requires additional systemic therapy

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Skin Cancer
Open to Enrollment

An Open-label, Multicenter, Dose-Escalation, Phase 1B/2 Study of the Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics of RTA 408 in Combination with Ipilimumab in the Treatment of Patients with Unresectable or Metastatic Melanoma

This proposed study is designed to assess the safety, efficacy, pharmacodynamics, and pharmacokinetics of RTA 408 in combination with ipilimumab in patients with unresectable or metastatic melanoma.

Investigator:
Eric Whitman, MD
408-C-1401 | PHASE I/II

Sponsor:
Reata Pharmaceuticals, Inc.

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

Inclusion Criteria:

- Be ≥18 years of age;
- Have advanced, unresectable (Stage III) or metastatic (Stage IV) melanoma;
- Have received no prior treatment with ipilimumab;
- Have discontinued previous treatments for cancer;
- Have discontinued previous experimental therapies for a minimum of 28 days;
Be able to swallow capsules.

Exclusion Criteria:
- Have prior malignancy active within the previous 2 years;
- Have any active autoimmune disease or a history of known or suspected autoimmune disease;
- History of brain metastases that meet certain conditions;
- History of specific cardiovascular abnormalities;
- Have known active fungal, bacterial, and/or viral infection, including human immunodeficiency virus (HIV) or hepatitis virus (A,B, or C).

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Skin Cancer
Open to Enrollment

Intralesional Injection (PV-10) vs Systemic Chemotherapy for Treatment of Locally Advanced Cutaneous Melanoma Without Distant Metastases

This is an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy with dacarbazine (DTIC) or temozolomide (TMZ) to assess treatment of locally advanced cutaneous melanoma in...

Investigator:
Eric Whitman, MD

patients who are BRAF V600 wild-type and have failed or are not otherwise candidates for at least one immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigator's choice of dacarbazine or temozolomide as determined by Investigator preference and/or local availability of the agent. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms.

PV-10-MM-31 | PHASE III

Sponsor:
Provectus Biopharmaceuticals, Inc.

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

Inclusion Criteria:
- Age 18 years or older, male or female
- Histologically or cytologically confirmed melanoma
- Stage IIIB or IIIC recurrent, satellite or in-transit cutaneous or subcutaneous melanoma
- At least 1 cutaneous Target Lesion > =10 mm in longest diameter. Target Lesions should be at least 10 mm from any other lesion
- No lesion > 30 mm in longest diameter; and no more than 20 lesions
- Calculated required PV-10 dose ≤ 15 mL (based on total tumor burden)
- Performance Status: Eastern Cooperative Oncology Group (ECOG) 0-2
- Failed, did not tolerate, or not a candidate for (due to co-morbidities, pre-existing autoimmune disease or drug unavailability) treatment with ipilimumab or another immune checkpoint inhibitor
- Not a candidate for treatment with vemurafenib, dabrafenib or trametinib (i.e., BRAF V600 wild-type)
- Life Expectancy: At least 6 months.

Clinical Laboratories:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L and platelet count ≥100 x 10^9/L
- Creatinine ≤ 3 times the upper limit of normal (ULN)
- Estimated creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2
- Total bilirubin ≤ 3 times the upper limit of normal (ULN)
- Aspartate transaminase (AST), alanine transaminase (ALT) and alkaline phosphatase (ALP) ≤ 5 times the upper limit of normal (ULN)
- Lactate dehydrogenase (LDH) ≤ 2 times the upper limit of normal (ULN).
- Thyroid function abnormality ≤ Grade 2

Exclusion Criteria:

- Presence or history of visceral or distant cutaneous or subcutaneous melanoma metastasis
- Presence of active nodal metastasis
- Presence of more than 20 melanoma lesions
- Radiation therapy to any Study Lesion within 4 weeks of initial study treatment.
- Chemotherapy or other systemic cancer therapy within 4 weeks of initial study treatment (6 weeks for nitrosoureas or mitomycin), or regional chemotherapy (limb infusion or perfusion) within 12 weeks of initial study treatment
- Immunotherapy for cancer within 4 weeks of initial study treatment
- Local treatment (e.g., surgery, cryotherapy, laser ablation) to any Study Lesion within 4 weeks of initial study treatment
- Anti-tumor vaccine therapy within 6 weeks of initial study treatment.
- Investigational agents within 4 weeks (or 5 half-lives) of initial study treatment.

Concurrent or Intercurrent Illness:
- Impaired wound healing or other extremity complications due to diabetes mellitus in subjects whose Study Lesions are located in an extremity
- Severe peripheral vascular disease in subjects whose Study Lesions are located in an extremity
- Significant concurrent or intercurrent illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the Investigator, compromise the subject's safety or compliance or interfere with interpretation of study results.
- Uncontrolled thyroid disease or cystic fibrosis
- Clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological, endocrine, or central nervous system disorders

Pregnancy:
- Female subjects who are pregnant or lactating
- Female subjects who have positive serum pregnancy test taken within 14 days of study treatment
- Female subjects of child-bearing potential who are not using effective contraception (e.g., oral contraceptives, intrauterine devices, double barrier methods such as condoms and diaphragms, abstinence or equivalent measures)

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research@atlantichealth.org

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Skin Cancer
Open to Enrollment

Open-label, Multi-center Phase IIa Study to Evaluate the Efficacy, Safety, and Immunological Response of OBP-301, Telomerase Specific Replication-competent Oncolytic Adenovirus in Patients with Unresectable Metastatic Melanoma

This is an open-label, multi-center Phase IIa study to evaluate the efficacy, safety, and immunological response of OBP-301, a telomerase specific replication-competent oncolytic adenovirus in patients with unresectable metastatic melanoma. This is a proof-of-concept...

Investigator:
Eric Whitman, MD

study that will be undertaken in male and female patients with unresectable Stage III and IV melanoma.

TL03001 | PHASE II

Sponsor:
Oncolys BioPharma 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. Histologically or cytologically confirmed malignant melanoma that is unresectable Stage IIIb, IIIc, or IV (M1a and M1b).
2. Patients must have received and failed or refused available therapy for Stage IIIb, IIIc, or IV melanoma (e.g., Imlygic™)
3. Patients must be ≥18 years of age.
4. At least 1 injectable tumor of ≥1 cm2 at Screening.
5. Measurable disease based on RECIST version 1.1 (other than a single injected lesion).
6. Patients with Stage IV, M1b melanoma must have less than 4 visceral lesions.
7. Willing to have biopsy specimens taken at Screening and at Cycle 6.
8. Life expectancy of ≥6 months from the date of enrollment.
9. Karnofsky Performance Status Scale (KPS) score of ≥70%.
10. Adequate organ function, hematologic status, coagulation status, kidney function, and liver function as follows:
◦Absolute neutrophils >1,500/µL
◦Hemoglobin >9 g/dL, without transfusion or hematopoietic growth factor
◦Platelets >100,000/µL,
◦International normalized ratio (INR) <2.0 and prothrombin time (PTT) within normal limits
◦Serum creatinine <2 × upper limit of normal (ULN)
◦Aspartate transaminase (AST) and alanine transaminase (ALT) <2 × ULN
◦Total bilirubin <2.0 mg/dL
◦Serum lactate dehydrogenase (LDH) levels <1.5 × ULN
11. Understand the study requirements and the treatment procedures, and is willing to comply with all specified follow-up evaluations, and provides written informed consent before any study-specific tests or procedures are performed.
12. Patients of reproductive potential must use effective contraception for the duration of the study and for 3 months (90 days) after the last administered dose with IP. Effective contraception includes oral contraceptives, implantable hormonal contraception, double-barrier method or intrauterine device.

Exclusion Criteria:
The presence of any of the following criteria will constitute cause for the exclusion of the participant:
1. Patients who have had administration of chemotherapy, target therapy, and/or immunotherapy within the last 4 weeks before enrollment.
2. Patients who have received other investigational medication within the last 4 weeks or a period of its 5 half-lives (whichever is shorter) before enrollment.
3. Patients who have had radiotherapy within the 4 weeks before Cycle 1, Day must have recovered from toxicities related to radiotherapy [to ≤Grade 1]) before administration of OBP 301.
4. Effects of any other prior therapies not reverted to ≤Grade 1 (or ≤Grade 2 for alopecia and peripheral neuropathy).
5. Patients with clinically active brain metastases.
6. Active or chronic infection, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV), except for asymptomatic bacterial colonization.
7. Patients diagnosed with additional malignancy within 5 years before enrollment with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancers.
8. Current requirement for chronic systemic immunosuppressive medication including pharmacologic dose of glucocorticoids (>10 mg prednisone) or cyclosporine, or chronic use of any such medication within the last 4 weeks before study enrollment.
9. Uncontrolled intercurrent illness including, but not limited to, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/psychological incompetence, whereby in the opinion of the Investigator the patient is assessed as being unable to provide information, consent, or comply with the study requirements and procedures.
10. Patients who are pregnant or breastfeeding, or expecting to conceive or father children within the projected timeframe of the study, starting from the time of the Screening Visit through 3 months (90 days) after administration of the last dose of IP. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at each visit before administration of the IP. A female not of childbearing potential is one who has undergone bilateral oophorectomy or who has had no menses for 12 consecutive months.

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973-971-5569
research@atlantichealth.org

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Skin Cancer
Open to Enrollment

Open-label, Multi-center Phase IIa Study to Evaluate the Efficacy, Safety, and Immunological Response of OBP-301, Telomerase Specific Replication-competent Oncolytic Adenovirus in Patients with Unresectable Metastatic Melanoma

This is an open-label, multi-center Phase IIa study to evaluate the efficacy, safety, and immunological response of OBP-301, a telomerase specific replication-competent oncolytic adenovirus in patients with unresectable metastatic melanoma. This is a proof-of-concept...

Investigator:
Eric Whitman, MD

study that will be undertaken in male and female patients with unresectable Stage III and IV melanoma.

TL03001 | PHASE II

Sponsor:
Oncolys BioPharma 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. Histologically or cytologically confirmed malignant melanoma that is unresectable Stage IIIb, IIIc, or IV (M1a and M1b).
2. Patients must have received and failed or refused available therapy for Stage IIIb, IIIc, or IV melanoma (e.g., Imlygic™)
3. Patients must be ≥18 years of age.
4. At least 1 injectable tumor of ≥1 cm2 at Screening.
5. Measurable disease based on RECIST version 1.1 (other than a single injected lesion).
6. Patients with Stage IV, M1b melanoma must have less than 4 visceral lesions.
7. Willing to have biopsy specimens taken at Screening and at Cycle 6.
8. Life expectancy of ≥6 months from the date of enrollment.
9. Karnofsky Performance Status Scale (KPS) score of ≥70%.
10. Adequate organ function, hematologic status, coagulation status, kidney function, and liver function as follows:
◦Absolute neutrophils >1,500/µL
◦Hemoglobin >9 g/dL, without transfusion or hematopoietic growth factor
◦Platelets >100,000/µL,
◦International normalized ratio (INR) <2.0 and prothrombin time (PTT) within normal limits
◦Serum creatinine <2 × upper limit of normal (ULN)
◦Aspartate transaminase (AST) and alanine transaminase (ALT) <2 × ULN
◦Total bilirubin <2.0 mg/dL
◦Serum lactate dehydrogenase (LDH) levels <1.5 × ULN
11. Understand the study requirements and the treatment procedures, and is willing to comply with all specified follow-up evaluations, and provides written informed consent before any study-specific tests or procedures are performed.
12. Patients of reproductive potential must use effective contraception for the duration of the study and for 3 months (90 days) after the last administered dose with IP. Effective contraception includes oral contraceptives, implantable hormonal contraception, double-barrier method or intrauterine device.

Exclusion Criteria:
The presence of any of the following criteria will constitute cause for the exclusion of the participant:
1. Patients who have had administration of chemotherapy, target therapy, and/or immunotherapy within the last 4 weeks before enrollment.
2. Patients who have received other investigational medication within the last 4 weeks or a period of its 5 half-lives (whichever is shorter) before enrollment.
3. Patients who have had radiotherapy within the 4 weeks before Cycle 1, Day must have recovered from toxicities related to radiotherapy [to ≤Grade 1]) before administration of OBP 301.
4. Effects of any other prior therapies not reverted to ≤Grade 1 (or ≤Grade 2 for alopecia and peripheral neuropathy).
5. Patients with clinically active brain metastases.
6. Active or chronic infection, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV), except for asymptomatic bacterial colonization.
7. Patients diagnosed with additional malignancy within 5 years before enrollment with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancers.
8. Current requirement for chronic systemic immunosuppressive medication including pharmacologic dose of glucocorticoids (>10 mg prednisone) or cyclosporine, or chronic use of any such medication within the last 4 weeks before study enrollment.
9. Uncontrolled intercurrent illness including, but not limited to, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/psychological incompetence, whereby in the opinion of the Investigator the patient is assessed as being unable to provide information, consent, or comply with the study requirements and procedures.
10. Patients who are pregnant or breastfeeding, or expecting to conceive or father children within the projected timeframe of the study, starting from the time of the Screening Visit through 3 months (90 days) after administration of the last dose of IP. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at each visit before administration of the IP. A female not of childbearing potential is one who has undergone bilateral oophorectomy or who has had no menses for 12 consecutive months.

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973-971-5569
research@atlantichealth.org

More info:
ClinicalTrials.gov

More Detail
Skin Cancer
Open to Enrollment

Open-label, Multi-center Phase IIa Study to Evaluate the Efficacy, Safety, and Immunological Response of OBP-301, Telomerase Specific Replication-competent Oncolytic Adenovirus in Patients with Unresectable Metastatic Melanoma

This is an open-label, multi-center Phase IIa study to evaluate the efficacy, safety, and immunological response of OBP-301, a telomerase specific replication-competent oncolytic adenovirus in patients with unresectable metastatic melanoma. This is a proof-of-concept...

Investigator:
Eric Whitman, MD

study that will be undertaken in male and female patients with unresectable Stage III and IV melanoma.

TL03001 | PHASE II

Sponsor:
Oncolys BioPharma 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. Histologically or cytologically confirmed malignant melanoma that is unresectable Stage IIIb, IIIc, or IV (M1a and M1b).
2. Patients must have received and failed or refused available therapy for Stage IIIb, IIIc, or IV melanoma (e.g., Imlygic™)
3. Patients must be ≥18 years of age.
4. At least 1 injectable tumor of ≥1 cm2 at Screening.
5. Measurable disease based on RECIST version 1.1 (other than a single injected lesion).
6. Patients with Stage IV, M1b melanoma must have less than 4 visceral lesions.
7. Willing to have biopsy specimens taken at Screening and at Cycle 6.
8. Life expectancy of ≥6 months from the date of enrollment.
9. Karnofsky Performance Status Scale (KPS) score of ≥70%.
10. Adequate organ function, hematologic status, coagulation status, kidney function, and liver function as follows:
◦Absolute neutrophils >1,500/µL
◦Hemoglobin >9 g/dL, without transfusion or hematopoietic growth factor
◦Platelets >100,000/µL,
◦International normalized ratio (INR) <2.0 and prothrombin time (PTT) within normal limits
◦Serum creatinine <2 × upper limit of normal (ULN)
◦Aspartate transaminase (AST) and alanine transaminase (ALT) <2 × ULN
◦Total bilirubin <2.0 mg/dL
◦Serum lactate dehydrogenase (LDH) levels <1.5 × ULN
11. Understand the study requirements and the treatment procedures, and is willing to comply with all specified follow-up evaluations, and provides written informed consent before any study-specific tests or procedures are performed.
12. Patients of reproductive potential must use effective contraception for the duration of the study and for 3 months (90 days) after the last administered dose with IP. Effective contraception includes oral contraceptives, implantable hormonal contraception, double-barrier method or intrauterine device.

Exclusion Criteria:
The presence of any of the following criteria will constitute cause for the exclusion of the participant:
1. Patients who have had administration of chemotherapy, target therapy, and/or immunotherapy within the last 4 weeks before enrollment.
2. Patients who have received other investigational medication within the last 4 weeks or a period of its 5 half-lives (whichever is shorter) before enrollment.
3. Patients who have had radiotherapy within the 4 weeks before Cycle 1, Day must have recovered from toxicities related to radiotherapy [to ≤Grade 1]) before administration of OBP 301.
4. Effects of any other prior therapies not reverted to ≤Grade 1 (or ≤Grade 2 for alopecia and peripheral neuropathy).
5. Patients with clinically active brain metastases.
6. Active or chronic infection, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV), except for asymptomatic bacterial colonization.
7. Patients diagnosed with additional malignancy within 5 years before enrollment with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancers.
8. Current requirement for chronic systemic immunosuppressive medication including pharmacologic dose of glucocorticoids (>10 mg prednisone) or cyclosporine, or chronic use of any such medication within the last 4 weeks before study enrollment.
9. Uncontrolled intercurrent illness including, but not limited to, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/psychological incompetence, whereby in the opinion of the Investigator the patient is assessed as being unable to provide information, consent, or comply with the study requirements and procedures.
10. Patients who are pregnant or breastfeeding, or expecting to conceive or father children within the projected timeframe of the study, starting from the time of the Screening Visit through 3 months (90 days) after administration of the last dose of IP. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at each visit before administration of the IP. A female not of childbearing potential is one who has undergone bilateral oophorectomy or who has had no menses for 12 consecutive months.

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Contact:
973-971-5569
research@atlantichealth.org

More info:
ClinicalTrials.gov

More Detail
Skin Cancer
Open to Enrollment

Open-label, Multi-center Phase IIa Study to Evaluate the Efficacy, Safety, and Immunological Response of OBP-301, Telomerase Specific Replication-competent Oncolytic Adenovirus in Patients with Unresectable Metastatic Melanoma

This is an open-label, multi-center Phase IIa study to evaluate the efficacy, safety, and immunological response of OBP-301, a telomerase specific replication-competent oncolytic adenovirus in patients with unresectable metastatic melanoma. This is a proof-of-concept...

Investigator:
Eric Whitman, MD

study that will be undertaken in male and female patients with unresectable Stage III and IV melanoma.

TL03001 | PHASE II

Sponsor:
Oncolys BioPharma 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. Histologically or cytologically confirmed malignant melanoma that is unresectable Stage IIIb, IIIc, or IV (M1a and M1b).
2. Patients must have received and failed or refused available therapy for Stage IIIb, IIIc, or IV melanoma (e.g., Imlygic™)
3. Patients must be ≥18 years of age.
4. At least 1 injectable tumor of ≥1 cm2 at Screening.
5. Measurable disease based on RECIST version 1.1 (other than a single injected lesion).
6. Patients with Stage IV, M1b melanoma must have less than 4 visceral lesions.
7. Willing to have biopsy specimens taken at Screening and at Cycle 6.
8. Life expectancy of ≥6 months from the date of enrollment.
9. Karnofsky Performance Status Scale (KPS) score of ≥70%.
10. Adequate organ function, hematologic status, coagulation status, kidney function, and liver function as follows:
◦Absolute neutrophils >1,500/µL
◦Hemoglobin >9 g/dL, without transfusion or hematopoietic growth factor
◦Platelets >100,000/µL,
◦International normalized ratio (INR) <2.0 and prothrombin time (PTT) within normal limits
◦Serum creatinine <2 × upper limit of normal (ULN)
◦Aspartate transaminase (AST) and alanine transaminase (ALT) <2 × ULN
◦Total bilirubin <2.0 mg/dL
◦Serum lactate dehydrogenase (LDH) levels <1.5 × ULN
11. Understand the study requirements and the treatment procedures, and is willing to comply with all specified follow-up evaluations, and provides written informed consent before any study-specific tests or procedures are performed.
12. Patients of reproductive potential must use effective contraception for the duration of the study and for 3 months (90 days) after the last administered dose with IP. Effective contraception includes oral contraceptives, implantable hormonal contraception, double-barrier method or intrauterine device.

Exclusion Criteria:
The presence of any of the following criteria will constitute cause for the exclusion of the participant:
1. Patients who have had administration of chemotherapy, target therapy, and/or immunotherapy within the last 4 weeks before enrollment.
2. Patients who have received other investigational medication within the last 4 weeks or a period of its 5 half-lives (whichever is shorter) before enrollment.
3. Patients who have had radiotherapy within the 4 weeks before Cycle 1, Day must have recovered from toxicities related to radiotherapy [to ≤Grade 1]) before administration of OBP 301.
4. Effects of any other prior therapies not reverted to ≤Grade 1 (or ≤Grade 2 for alopecia and peripheral neuropathy).
5. Patients with clinically active brain metastases.
6. Active or chronic infection, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV), except for asymptomatic bacterial colonization.
7. Patients diagnosed with additional malignancy within 5 years before enrollment with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancers.
8. Current requirement for chronic systemic immunosuppressive medication including pharmacologic dose of glucocorticoids (>10 mg prednisone) or cyclosporine, or chronic use of any such medication within the last 4 weeks before study enrollment.
9. Uncontrolled intercurrent illness including, but not limited to, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/psychological incompetence, whereby in the opinion of the Investigator the patient is assessed as being unable to provide information, consent, or comply with the study requirements and procedures.
10. Patients who are pregnant or breastfeeding, or expecting to conceive or father children within the projected timeframe of the study, starting from the time of the Screening Visit through 3 months (90 days) after administration of the last dose of IP. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at each visit before administration of the IP. A female not of childbearing potential is one who has undergone bilateral oophorectomy or who has had no menses for 12 consecutive months.

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Contact:
973-971-5569
research@atlantichealth.org

More info:
ClinicalTrials.gov

More Detail
Skin Cancer
Open to Enrollment

Phase Ib Study of Intratumoral CAVATAK™ (Coxsackievirus A21) and Ipilimumab in Patients With Advanced Melanoma

The study will use the established dose of CAVATAK with ipilimumab in patients with advanced melanoma for whom ipilimumab would be considered standard of care. Treatment with CAVATAK will be on days 1, 3, 5 and 8 and then both agents will be co-administered...

Investigator:
Eric Whitman, MD

on days 22, 43, 64 and 85. Patients with clinical benefit can continue CAVATAK every 3 weeks for up to one year,

VLA-013 | PHASE I

Sponsor:
Viralytics Limited

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 with metastatic or unresectable stage IIIc or IV melanoma for whom treatment with ipilimumab is indicated
• At least one tumor must qualify to be a target lesion for irRC-WHO
• ECOG of 0-1
• Women of childbearing potential must have a negative serum or urine pregnancy test performed within 72 hour prior to the start of treatment
• No active bleeding
• Life expectancy > 12 weeks

Exclusion Criteria:
• Prior ipilimumab treatment for metastatic melanoma (prior ipilimumab as adjuvant permitted if no ≥ grade 3 toxicity)
• Tumors to be injected lying in mucosal regions or close to airway, major blood vessel or spinal cord that could cause occlusion or compression due to tumor swelling or erosion
• Active autoimmune disease (excluding autoimmune thyroiditis or vitiligo)
• Patients with history of colitis
• Untreated brain metastases.
• Other active metastatic cancer requiring treatment
• Active infection requiring antibiotics
• Pregnant or lactating women
• Need for chronic steroids
• Within 28 days of enrollment: WBC < 3.1 x 10⁹ /L; Hgb < 9.0 g/dL; AST or ALT > 1.5 upper limit of normal (ULN); total bilirubin > 1.9 g/dL; prior HIV; prior Hepatitis B; prior Hepatitis C; INR > 1.5 x ULN

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Contact:
973-971-5569
research@atlantichealth.org

More info:
ClinicalTrials.gov