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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. 

Showing 10 Results for Ovarian Cancer

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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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Contact:
973-971-6608
research@atlantichealth.org

More info:
ClinicalTrials.gov

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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.

Contact:
973-971-6608
research@atlantichealth.org

More info:
ClinicalTrials.gov

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

More info:
ClinicalTrials.gov

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

More info:
ClinicalTrials.gov

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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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Contact:
973-971-5568
research@atlantichealth.org

More info:
ClinicalTrials.gov

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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

Contact:
973-971-6608
research@atlantichealth.org

More info:
ClinicalTrials.gov

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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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Contact:
973-971-6608
research@atlantichealth.org

More info:
ClinicalTrials.gov

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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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Contact:
973-971-6608
research@atlantichealth.org

More info:
ClinicalTrials.gov

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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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Contact:
973-219-1264
research@atlantichealth.org

More info:
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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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More info:
ClinicalTrials.gov