Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036)

Completed · Phase 3 · Has a placebo group

Conditions studied: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms

In brief

The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel\* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer. The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel\* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1) positive tumors (Combined Positive Score \[CPS\]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1 positive tumors (CPS≥10) and in all participants.

Key facts

Study ID: NCT03740165
Run by: Merck Sharp & Dohme LLC
People needed: 1367
Starts: 2018-12-18
Expected to finish: 2026-04-15
Last updated by the study team: 2026-05-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Has histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer
Has just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery
Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting
Candidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25
Is able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 3 days prior to Day 1 of Cycle 1
Female participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Has adequate organ function

You may not qualify if…

Has mucinous, germ cell, or borderline tumor of the ovary
Has a known or suspected deleterious mutation (germline or somatic) in either BRCA1 or BRCA2
Has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis
Has either myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
Has a known additional malignancy that is progressing or has required active treatment in the last 3 years Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. ductal carcinoma in situ, cervical carcinoma in situ) that has undergone potentially curative therapy are not excluded.
Has ongoing Grade 3 or Grade 4 toxicity, excluding alopecia, following chemotherapy administered during the lead-in period
Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with brain metastases may participate provided they were previously treated (except with chemotherapy) and are radiologically stable, clinically stable, and no steroids were used for the management of symptoms related to brain metastases within 14 days prior to randomization. Stable brain metastases should be established prior to the first dose of study medication lead-in chemotherapy
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing >10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
Has a known history of active tuberculosis (TB; Bacillus Tuberculosis)
Has an active infection requiring systemic therapy
Has received colony-stimulating factors (eg, granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 4 weeks prior to receiving chemotherapy during the lead-in period
Is considered to be of poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection
Has had surgery to treat borderline tumors, early stage EOC, or early stage fallopian tube cancer <6 months prior to screening
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Testing for hepatitis B or hepatitis C is required at screening only if mandated by local health authority. Note: Participants with a history of hepatitis B but who are HBsAg negative are eligible for the study
Is either unable to swallow orally administered medication or has a gastrointestinal (GI) disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, malabsorption)
Has uncontrolled hypertension
Has current, clinically relevant bowel obstruction (including sub-occlusive disease), abdominal fistula or GI perforation, related to underlying EOC (for participants receiving bevacizumab)
Has a history of hemorrhage, hemoptysis or active GI bleeding within 6 months prior to randomization (for participants receiving bevacizumab)
Is a WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of chemotherapy in the lead-in period and within 72 hours prior to Day 1 of Cycle 1, is pregnant or breastfeeding, or is expecting to conceive children within the projected duration of the study, starting with screening through 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy
Has received prior treatment for any stage of OC, including radiation or systemic anti-cancer therapy (e.g. chemotherapy, hormonal therapy, immunotherapy, investigational therapy)
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 stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T lymphocyte antigen-4 [CTLA-4], OX 40, CD137)
Has received prior therapy with either olaparib or any other poly(adenosine-ribose) polymerase (PARP) inhibitor
Has intraperitoneal chemotherapy planned or has been administered as first-line therapy

Where it is running

University of Arizona Cancer Center ( Site 0074) — Tucson, Arizona, United States
Disney Family Cancer Center ( Site 0042) — Burbank, California, United States
Kaiser Permanente Oncology Clinical Trial -Oakland ( Site 0077) — Oakland, California, United States
Kaiser Permanente Oncology Clinical Trials-Roseville ( Site 0084) — Roseville, California, United States
Kaiser Permanente Oncology Clinical Trials-Sacramento ( Site 0083) — Sacramento, California, United States
Kaiser Permanente Oncology Clinical Trial - San Francisco ( Site 0078) — San Francisco, California, United States
Kaiser Permanente Oncology Clinical Trial - Santa Clara ( Site 0079) — Santa Clara, California, United States
Kaiser Permanente N. CA Regional Oncology Clinical Trials ( Site 0008) — Vallejo, California, United States
Kaiser Permanente Oncology Clinical Trial - Walnut Creek ( Site 0080) — Walnut Creek, California, United States
Smilow Cancer Center at Yale-New Haven ( Site 0057) — New Haven, Connecticut, United States
Sarasota Memorial Hospital ( Site 0023) — Sarasota, Florida, United States
Emory School of Medicine ( Site 0053) — Atlanta, Georgia, United States
Northeast Georgia Medical Center ( Site 0029) — Gainesville, Georgia, United States
Memorial Health University Medical Center ( Site 0011) — Savannah, Georgia, United States
Rush University Medical Center ( Site 0019) — Chicago, Illinois, United States
University of Chicago ( Site 0049) — Chicago, Illinois, United States
Dr. Sudarshan K. Sharma, LTD ( Site 0061) — Hinsdale, Illinois, United States
Saint Vincent Hospital and Health Center ( Site 0012) — Indianapolis, Indiana, United States
University of Iowa Hospital and Clinics ( Site 0005) — Iowa City, Iowa, United States
University of Kentucky ( Site 0045) — Lexington, Kentucky, United States
Weinberg Cancer Institute at Franklin Square ( Site 0035) — Baltimore, Maryland, United States
Saint Dominic - Jackson Memorial Hospital ( Site 0072) — Jackson, Mississippi, United States
Washington University - School of Medicine ( Site 0062) — St Louis, Missouri, United States
Nebraska Methodist Hospital ( Site 0063) — Omaha, Nebraska, United States
University of Alabama at Birmingham (UAB) ( Site 0036) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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