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)

NCT ID: NCT03740165

Last Updated: 2025-10-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1367 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-18

Study Completion Date

2026-05-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin/paclitaxel\*, participants will be randomly assigned in to one of three treatment arms, and will receive carboplatin/paclitaxel\* for 5 cycles plus:

* Pembrolizumab + Olaparib
* Pembrolizumab + Placebo for Olaparib
* Placebo for Pembrolizumab + Placebo for Olaparib

* At Investigator's discretion and prior to participant randomization, one of the following carboplatin/paclitaxel regimens is to be selected:

1. up to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg/m\^2 on Day 1 of each 3-week cycle
2. up to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg/m\^2 on Days 1, 8 and 15 of each 3-week cycle; or
3. up to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg/m\^2 on Days 1, 8 and 15 of each 3-week cycle.

Docetaxel may be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation with the Sponsor. The recommended dose as determined by the Scottish Gynaecological Cancer Trials Group is Docetaxel 75 mg/m\^2 Q3W plus carboplatin AUC 5 Q3W.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Cancer Fallopian Tube Cancer Peritoneal Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Carboplatin + Paclitaxel + Pembrolizumab + Olaparib

Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

IV infusion

Carboplatin

Intervention Type DRUG

IV infusion

Paclitaxel

Intervention Type DRUG

IV infusion

Olaparib

Intervention Type DRUG

Oral tablet

Bevacizumab

Intervention Type BIOLOGICAL

IV infusion

Docetaxel

Intervention Type DRUG

IV infusion

Carboplatin + Paclitaxel + Pembrolizumab

Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles starting in Cycle 1 PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

IV infusion

Carboplatin

Intervention Type DRUG

IV infusion

Paclitaxel

Intervention Type DRUG

IV infusion

Placebo for olaparib

Intervention Type DRUG

Oral tablet

Bevacizumab

Intervention Type BIOLOGICAL

IV infusion

Docetaxel

Intervention Type DRUG

IV infusion

Carboplatin + Paclitaxel

Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles PLUS placebo for pembrolizumab (normal saline or dextrose) via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Group Type ACTIVE_COMPARATOR

Placebo for pembrolizumab

Intervention Type DRUG

IV infusion

Carboplatin

Intervention Type DRUG

IV infusion

Paclitaxel

Intervention Type DRUG

IV infusion

Placebo for olaparib

Intervention Type DRUG

Oral tablet

Bevacizumab

Intervention Type BIOLOGICAL

IV infusion

Docetaxel

Intervention Type DRUG

IV infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pembrolizumab

IV infusion

Intervention Type BIOLOGICAL

Placebo for pembrolizumab

IV infusion

Intervention Type DRUG

Carboplatin

IV infusion

Intervention Type DRUG

Paclitaxel

IV infusion

Intervention Type DRUG

Olaparib

Oral tablet

Intervention Type DRUG

Placebo for olaparib

Oral tablet

Intervention Type DRUG

Bevacizumab

IV infusion

Intervention Type BIOLOGICAL

Docetaxel

IV infusion

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MK-3475 KEYTRUDA® normal saline or dextrose PARAPLATIN® TAXOL® MK-7339 LYNPARZA® AVASTIN®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Has received a live vaccine within 30 days prior to the first dose of study treatment on Day 1 of Cycle 1
* Has severe hypersensitivity (≥Grade 3) to pembrolizumab, olaparib, carboplatin, paclitaxel or bevacizumab (if using) and/or any of their excipients
* Is currently receiving either strong (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
* Is currently receiving either strong (e.g. phenobarbital, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine, and St John's Wort) or moderate (e.g. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study
* Is currently participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks (28 days) of starting chemotherapy in the Lead-in Period
* Has resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions or participant has congenital long QT syndrome
* Has had an allogenic tissue/solid organ transplant, has received previous allogenic bone-marrow transplant, or has received double umbilical cord transplantation
* Either has had major surgery within 3 weeks of randomization or has not recovered from any effects of any major surgery
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

European Network of Gynaecological Oncological Trial Groups (ENGOT)

OTHER

Sponsor Role collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama at Birmingham (UAB) ( Site 0036)

Birmingham, Alabama, United States

Site Status

University of Arizona Cancer Center ( Site 0074)

Tucson, Arizona, United States

Site Status

Disney Family Cancer Center ( Site 0042)

Burbank, California, United States

Site Status

Kaiser Permanente Oncology Clinical Trial -Oakland ( Site 0077)

Oakland, California, United States

Site Status

Kaiser Permanente Oncology Clinical Trials-Roseville ( Site 0084)

Roseville, California, United States

Site Status

Kaiser Permanente Oncology Clinical Trials-Sacramento ( Site 0083)

Sacramento, California, United States

Site Status

Kaiser Permanente Oncology Clinical Trial - San Francisco ( Site 0078)

San Francisco, California, United States

Site Status

Kaiser Permanente Oncology Clinical Trial - Santa Clara ( Site 0079)

Santa Clara, California, United States

Site Status

Kaiser Permanente N. CA Regional Oncology Clinical Trials ( Site 0008)

Vallejo, California, United States

Site Status

Kaiser Permanente Oncology Clinical Trial - Walnut Creek ( Site 0080)

Walnut Creek, California, United States

Site Status

Smilow Cancer Center at Yale-New Haven ( Site 0057)

New Haven, Connecticut, United States

Site Status

Sarasota Memorial Hospital ( Site 0023)

Sarasota, Florida, United States

Site Status

Emory School of Medicine ( Site 0053)

Atlanta, Georgia, United States

Site Status

Northeast Georgia Medical Center ( Site 0029)

Gainesville, Georgia, United States

Site Status

Memorial Health University Medical Center ( Site 0011)

Savannah, Georgia, United States

Site Status

Rush University Medical Center ( Site 0019)

Chicago, Illinois, United States

Site Status

University of Chicago ( Site 0049)

Chicago, Illinois, United States

Site Status

Dr. Sudarshan K. Sharma, LTD ( Site 0061)

Hinsdale, Illinois, United States

Site Status

Saint Vincent Hospital and Health Center ( Site 0012)

Indianapolis, Indiana, United States

Site Status

University of Iowa Hospital and Clinics ( Site 0005)

Iowa City, Iowa, United States

Site Status

University of Kentucky ( Site 0045)

Lexington, Kentucky, United States

Site Status

Weinberg Cancer Institute at Franklin Square ( Site 0035)

Baltimore, Maryland, United States

Site Status

Saint Dominic - Jackson Memorial Hospital ( Site 0072)

Jackson, Mississippi, United States

Site Status

Washington University - School of Medicine ( Site 0062)

St Louis, Missouri, United States

Site Status

Nebraska Methodist Hospital ( Site 0063)

Omaha, Nebraska, United States

Site Status

Dartmouth Hitchcock Medical Center ( Site 0024)

Lebanon, New Hampshire, United States

Site Status

MD Anderson Cancer Center at Cooper ( Site 0067)

Camden, New Jersey, United States

Site Status

Holy Name Medical Center ( Site 0037)

Teaneck, New Jersey, United States

Site Status

Northwell Health- Monter Cancer Center ( Site 0075)

Lake Success, New York, United States

Site Status

Sanford Roger Maris Cancer Center ( Site 0082)

Fargo, North Dakota, United States

Site Status

Miami Valley Hospital [Dayton, OH] ( Site 0073)

Centerville, Ohio, United States

Site Status

Oncology/Hematology Care Clinical Trials, LLC ( Site 8001)

Cincinnati, Ohio, United States

Site Status

The Bing Cancer Center ( Site 0044)

Columbus, Ohio, United States

Site Status

OSU Wexner Medical Center ( Site 0076)

Hilliard, Ohio, United States

Site Status

Women and Infants Hospital [Providence, RI] ( Site 0039)

Providence, Rhode Island, United States

Site Status

Sanford Gynecology Oncology ( Site 0004)

Sioux Falls, South Dakota, United States

Site Status

Texas Oncology, P.A. - Bedford ( Site 8005)

Bedford, Texas, United States

Site Status

Texas Oncology-Dallas Presbyterian Hospital ( Site 8004)

Dallas, Texas, United States

Site Status

Parkland Hospital ( Site 0081)

Dallas, Texas, United States

Site Status

UT Southwestern Medical Center ( Site 0046)

Dallas, Texas, United States

Site Status

Texas Oncology, P.A. Texas Oncology-Tyler ( Site 8006)

Tyler, Texas, United States

Site Status

Virginia Cancer Specialists, PC ( Site 8003)

Gainesville, Virginia, United States

Site Status

MEDICAL COLLEGE OF WISCONSIN ( Site 0064)

Milwaukee, Wisconsin, United States

Site Status

St George Hospital ( Site 2207)

Kogarah, New South Wales, Australia

Site Status

Cairns and Hinterland Hospital and Health Service ( Site 2201)

Cairns, Queensland, Australia

Site Status

Ballarat Health Services ( Site 2202)

Ballarat, Victoria, Australia

Site Status

Monash Health ( Site 2204)

Clayton, Victoria, Australia

Site Status

Sunshine Hospital. ( Site 2205)

St Albans, Victoria, Australia

Site Status

Imelda Ziekenhuis Bonheiden ( Site 0301)

Bonheiden, Antwerpen, Belgium

Site Status

UZ Leuven Campus Gasthuisberg ( Site 0306)

Leuven, Antwerpen, Belgium

Site Status

Cliniques Universitaires Saint-Luc ( Site 0312)

Brussels, Bruxelles-Capitale, Region de, Belgium

Site Status

Grand Hopital de Charleroi ( Site 0302)

Charleroi, Hainaut, Belgium

Site Status

CHU de Liege ( Site 0310)

Liège, Liege, Belgium

Site Status

Jessa Ziekenhuis ( Site 0309)

Hasselt, Limburg, Belgium

Site Status

Centre Hospitalier de l'Ardenne ( Site 0303)

Libramont, Luxembourg, Belgium

Site Status

AZ Maria Middelares Gent ( Site 0300)

Ghent, Oost-Vlaanderen, Belgium

Site Status

UZ Gent ( Site 0307)

Ghent, Oost-Vlaanderen, Belgium

Site Status

Instituto do Cancer do Ceara ( Site 2707)

Fortaleza, Ceará, Brazil

Site Status

Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2708)

Goiânia, Goiás, Brazil

Site Status

Hospital Erasto Gaertner ( Site 2716)

Curitiba, Paraná, Brazil

Site Status

Hospital de Caridade de Ijui ( Site 2712)

Ijuí, Rio Grande do Sul, Brazil

Site Status

Hospital Bruno Born ( Site 2704)

Lajeado, Rio Grande do Sul, Brazil

Site Status

Hospital Nossa Senhora Da Conceicao ( Site 2703)

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Instituto Nacional de Cancer Hospital do Cancer II ( Site 2700)

Rio de Janeiro, , Brazil

Site Status

Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 2714)

São Paulo, , Brazil

Site Status

Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706)

São Paulo, , Brazil

Site Status

Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2710)

São Paulo, , Brazil

Site Status

Tom Baker Cancer Centre ( Site 0200)

Calgary, Alberta, Canada

Site Status

Kingston Health Sciences Centre ( Site 0207)

Kingston, Ontario, Canada

Site Status

The Credit Valley Hospital ( Site 0206)

Mississauga, Ontario, Canada

Site Status

Princess Margaret Hospital.. ( Site 0202)

Toronto, Ontario, Canada

Site Status

CIUSSS du Saguenay-Lac-St-Jean ( Site 0218)

Chicoutimi, Quebec, Canada

Site Status

CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0219)

Montreal, Quebec, Canada

Site Status

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0208)

Montreal, Quebec, Canada

Site Status

Royal Victoria Hospital McGill University Health Centre ( Site 0211)

Montreal, Quebec, Canada

Site Status

Fundacion Arturo Lopez Perez FALP ( Site 2800)

Santiago, Region M. de Santiago, Chile

Site Status

Sociedad Oncovida S.A. ( Site 2807)

Santiago, Region M. de Santiago, Chile

Site Status

Iram Cancer Research ( Site 2809)

Santiago, Region M. de Santiago, Chile

Site Status

Pontificia Universidad Catolica de Chile ( Site 2805)

Santiago, Region M. de Santiago, Chile

Site Status

Centro Investigación del Cáncer James Lind ( Site 2810)

Temuco, Región de la Araucanía, Chile

Site Status

Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 2808)

Temuco, Región de la Araucanía, Chile

Site Status

Oncocentro ( Site 2801)

Viña del Mar, Región de Valparaíso, Chile

Site Status

Centro Oncologico Antofagasta ( Site 2804)

Antofagasta, , Chile

Site Status

Biomelab S A S ( Site 2900)

Barranquilla, Atlántico, Colombia

Site Status

Instituto Nacional de Cancerologia E.S.E ( Site 2910)

Bogotá, Bogota D.C., Colombia

Site Status

Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2912)

Bogotá, Bogota D.C., Colombia

Site Status

Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2913)

Valledupar, Cesar Department, Colombia

Site Status

Oncomedica S.A. ( Site 2911)

Montería, Departamento de Córdoba, Colombia

Site Status

Centro Medico Imbanaco de Cali S.A ( Site 2909)

Cali, Valle del Cauca Department, Colombia

Site Status

Hemato Oncologos S.A. ( Site 2906)

Cali, Valle del Cauca Department, Colombia

Site Status

Fakultni nemocnice Brno ( Site 0404)

Brno, Brno-mesto, Czechia

Site Status

Fakultni nemocnice Ostrava ( Site 0403)

Ostrava-Poruba, Moravskoslezský kraj, Czechia

Site Status

Vseobecna fakultni nemocnice v Praze ( Site 0400)

Prague, Praha, Hlavni Mesto, Czechia

Site Status

Nemocnice Na Bulovce ( Site 0401)

Prague, Praha, Hlavni Mesto, Czechia

Site Status

Fakultni nemocnice Olomouc ( Site 0402)

Olomouc, , Czechia

Site Status

Hopital Prive Jean Mermoz ( Site 0607)

Lyon, Auvergne, France

Site Status

Centre Paul Strauss ( Site 0615)

Strasbourg, Bas-Rhin, France

Site Status

Hopital de la Timone ( Site 0617)

Marseille, Bouches-du-Rhone, France

Site Status

CHU de Brest -Site Hopital Morvan ( Site 0616)

Brest, Brittany Region, France

Site Status

Institut de Cancerologie du Gard - CHU Caremeau ( Site 0610)

Nîmes, Gard, France

Site Status

Centre D Oncologie de Gentilly ( Site 0609)

Nancy, Meurthe-et-Moselle, France

Site Status

Institut de Cancerologie Lucien Neuwirth ( Site 0613)

Saint-Priest-en-Jarez, Pays de la Loire Region, France

Site Status

Institut Gustave Roussy ( Site 0600)

Villejuif, Val-de-Marne, France

Site Status

Hopital Tenon ( Site 0612)

Paris, , France

Site Status

Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0707)

Stuttgart, Baden-Wurttemberg, Germany

Site Status

Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0710)

Munich, Bavaria, Germany

Site Status

Uniklinik RWTH Aachen ( Site 0718)

Aachen, North Rhine-Westphalia, Germany

Site Status

Gynaekologisches Zentrum ( Site 0712)

Bonn, North Rhine-Westphalia, Germany

Site Status

Klinikum Dortmund gGmbH ( Site 0717)

Dortmund, North Rhine-Westphalia, Germany

Site Status

Universitaetsklinikum Duesseldorf ( Site 0704)

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

HELIOS Klinikum Krefeld ( Site 0715)

Krefeld, North Rhine-Westphalia, Germany

Site Status

Universitaetsklinikum Muenster ( Site 0720)

Münster, North Rhine-Westphalia, Germany

Site Status

Caritas Klinikum Saarbruecken St. Theresia ( Site 0702)

Saarbrücken, Saarland, Germany

Site Status

Klinikum Chemnitz gGmbH ( Site 0711)

Chemnitz, Saxony, Germany

Site Status

Staedtisches Krankenhaus Kiel GmbH ( Site 0709)

Kiel, Schleswig-Holstein, Germany

Site Status

Charite Campus Virchow-Klinikum - CVK ( Site 0700)

Berlin, , Germany

Site Status

Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 0805)

Pécs, Baranya, Hungary

Site Status

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz ( Site 0802)

Miskolc, Borsod-Abauj Zemplen county, Hungary

Site Status

Orszagos Onkologiai Intezet ( Site 0800)

Budapest, , Hungary

Site Status

Uzsoki Utcai Korhaz ( Site 0803)

Budapest, , Hungary

Site Status

Debreceni Egyetem Klinikai Kozpont ( Site 0801)

Debrecen, , Hungary

Site Status

Soroka Medical Center ( Site 1006)

Beersheba, , Israel

Site Status

Hillel Yaffe Medical Center ( Site 1011)

Hadera, , Israel

Site Status

Carmel Medical Center ( Site 1007)

Haifa, , Israel

Site Status

Rambam Medical Center ( Site 1002)

Haifa, , Israel

Site Status

Edith Wolfson Medical Center ( Site 1003)

Holon, , Israel

Site Status

Shaare Zedek Medical Center ( Site 1005)

Jerusalem, , Israel

Site Status

Rabin Medical Center ( Site 1004)

Petah Tikva, , Israel

Site Status

Chaim Sheba Medical Center ( Site 1000)

Ramat Gan, , Israel

Site Status

Sourasky Medical Center ( Site 1001)

Tel Aviv, , Israel

Site Status

IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1108)

Bari, Abruzzo, Italy

Site Status

Istituto Europeo di Oncologia ( Site 1100)

Milan, Lombardy, Italy

Site Status

A.O.U. Citta della Salute e della Scienza di Torino ( Site 1104)

Turin, Piedmont, Italy

Site Status

Istituto Oncologico Veneto IRCCS ( Site 1113)

Padua, Veneto, Italy

Site Status

Sacro Cuore di Gesu Fatebenefratelli ( Site 1112)

Benevento, , Italy

Site Status

Ospedale Cannizzaro ( Site 1110)

Catania, , Italy

Site Status

ASST Lecco. Ospedale A. Manzoni ( Site 1101)

Lecco, , Italy

Site Status

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1115)

Milan, , Italy

Site Status

A.O.U. Federico II di Napoli ( Site 1107)

Napoli, , Italy

Site Status

Azienda Ospedaliera Policlinico Umberto I ( Site 1111)

Roma, , Italy

Site Status

Policlinico Universitario Gemelli ( Site 1105)

Roma, , Italy

Site Status

Presidio Ospedaliero Santa Chiara ( Site 1109)

Trento, , Italy

Site Status

A.O. Univ. S. M. della Misericordia ( Site 1114)

Udine, , Italy

Site Status

National Cancer Center Hospital East ( Site 2602)

Kashiwa, Chiba, Japan

Site Status

National Hospital Organization Shikoku Cancer Center ( Site 2601)

Matsuyama, Ehime, Japan

Site Status

Ehime University Hospital ( Site 2600)

Tōon, Ehime, Japan

Site Status

Gunma Prefectural Cancer Center ( Site 2609)

Ōta, Gunma, Japan

Site Status

Hokkaido University Hospital ( Site 2607)

Sapporo, Hokkaido, Japan

Site Status

Iwate Medical University Hospital ( Site 2606)

Shiwa-gun, Iwate, Japan

Site Status

St. Marianna University School of Medicine Hospital ( Site 2613)

Kawasaki, Kanagawa, Japan

Site Status

University of the Ryukyus Hospital ( Site 2616)

Nakagami-gun, Okinawa, Japan

Site Status

Saitama Medical University International Medical Center ( Site 2604)

Hidaka, Saitama, Japan

Site Status

Saitama Cancer Center ( Site 2614)

Kitaadachi-gun, Saitama, Japan

Site Status

National Defense Medical College Hospital ( Site 2608)

Tokorozawa, Saitama, Japan

Site Status

Kyorin University Hospital ( Site 2610)

Mitaka, Tokyo, Japan

Site Status

Kagoshima City Hospital ( Site 2612)

Kagoshima, , Japan

Site Status

Niigata Cancer Center Hospital ( Site 2618)

Niigata, , Japan

Site Status

Osaka International Cancer Institute ( Site 2617)

Osaka, , Japan

Site Status

National Cancer Center Hospital ( Site 2605)

Tokyo, , Japan

Site Status

Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna

Poznan, Greater Poland Voivodeship, Poland

Site Status

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

Warsaw, Masovian Voivodeship, Poland

Site Status

Bialostockie Centrum Onkologii ( Site 1412)

Bialystok, Podlaskie Voivodeship, Poland

Site Status

Szpitale Pomorskie Sp. z o.o. ( Site 1407)

Gdynia, Pomeranian Voivodeship, Poland

Site Status

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1406)

Gliwice, Silesian Voivodeship, Poland

Site Status

Swietokrzyskie Centrum Onkologii SPZOZ ( Site 1410)

Kielce, Świętokrzyskie Voivodeship, Poland

Site Status

Arkhangelsk Clinical Oncological Dispensary ( Site 1508)

Arkhangelsk, Arkhangelskaya oblast, Russia

Site Status

Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507)

Ufa, Baskortostan, Respublika, Russia

Site Status

A. Tsyb Medical Radiological Research Center ( Site 1513)

Obninsk, Kaluzskaja Oblast, Russia

Site Status

FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1500)

Moscow, Moscow, Russia

Site Status

FSCC of Special Types of Med. Care and Technologies ( Site 1503)

Moscow, Moscow, Russia

Site Status

Medical Rehabilitation Center ( Site 1502)

Moscow, Moscow, Russia

Site Status

National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1504)

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

City Clinical Oncology Center ( Site 1505)

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1509)

Kazan', Tatarstan, Respublika, Russia

Site Status

Cancer Care Langenhoven Drive Oncology Centre ( Site 1701)

Port Elizabeth, Eastern Cape, South Africa

Site Status

Groote Schuur Hospital ( Site 1704)

Cape Town, Gauteng, South Africa

Site Status

Wits Clinical Research ( Site 1702)

Johannesburg, Gauteng, South Africa

Site Status

Department of Medical Oncology ( Site 1703)

Pretoria, Gauteng, South Africa

Site Status

Curo Oncology ( Site 1710)

Pretoria, Gauteng, South Africa

Site Status

Wilgers Oncology Centre ( Site 1705)

Pretoria, Gauteng, South Africa

Site Status

Little Company of Mary Hospital ( Site 1700)

Pretoria, Gauteng, South Africa

Site Status

Sandton Oncology Medical Group PTY LTD ( Site 1712)

Sandton, Gauteng, South Africa

Site Status

The Oncology Centre ( Site 1709)

Durban, KwaZulu-Natal, South Africa

Site Status

Cancercare ( Site 1706)

Cape Town, Western Cape, South Africa

Site Status

Outeniqua Cancercare Oncology Unit ( Site 1708)

George, Western Cape, South Africa

Site Status

Cape Town Oncology Trials Pty Ltd ( Site 1707)

Kraaifontein, Western Cape, South Africa

Site Status

Seoul National University Bundang Hospital ( Site 2404)

Seongnam-si, Kyonggi-do, South Korea

Site Status

Seoul National University Hospital ( Site 2403)

Seoul, , South Korea

Site Status

Severance Hospital Yonsei University Health System ( Site 2400)

Seoul, , South Korea

Site Status

Asan Medical Center ( Site 2402)

Seoul, , South Korea

Site Status

Samsung Medical Center ( Site 2401)

Seoul, , South Korea

Site Status

Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1603)

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Xarxa Assistencial Universitaria Manresa ( Site 1605)

Manresa, Barcelona, Spain

Site Status

Hospital de Terrassa ( Site 1606)

Terrassa, Barcelona, Spain

Site Status

Hospital Universitario de Donostia ( Site 1602)

Donostia / San Sebastian, Gipuzkoa, Spain

Site Status

Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1608)

A Coruña, La Coruna, Spain

Site Status

Instituto Valenciano de Oncologia ( Site 1601)

Valencia, Valenciana, Comunitat, Spain

Site Status

Hospital General Universitario de Valencia ( Site 1610)

Valencia, Valenciana, Comunitat, Spain

Site Status

Hospital Provincial San Pedro de Alcantara ( Site 1607)

Cáceres, , Spain

Site Status

Hospital Universitario Lucus Augusti ( Site 1609)

Lugo, , Spain

Site Status

Clinica Universitaria de Navarra ( Site 1600)

Madrid, , Spain

Site Status

Hospital Universitario Virgen del Rocio ( Site 1604)

Seville, , Spain

Site Status

Changhua Christian Hospital ( Site 2507)

Changhua, , Taiwan

Site Status

China Medical University Hospital ( Site 2506)

Taichung, , Taiwan

Site Status

Taichung Veterans General Hospital ( Site 2510)

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital ( Site 2508)

Tainan City, , Taiwan

Site Status

National Taiwan University Hospital ( Site 2502)

Taipei, , Taiwan

Site Status

MacKay Memorial Hospital ( Site 2500)

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital ( Site 2503)

Taipei, , Taiwan

Site Status

Linkou Chang Gung Memorial Hospital ( Site 2501)

Taoyuan District, , Taiwan

Site Status

Istanbul Acibadem University Atakent Hospital ( Site 1902)

Küçükçekmece, Istanbul, Turkey (Türkiye)

Site Status

Etlik Zubeyde Hanim Kadin Hastaliklari Egitim ve Arastirma Hastanesi ( Site 1903)

Ankara, , Turkey (Türkiye)

Site Status

Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 1905)

Ankara, , Turkey (Türkiye)

Site Status

Akdeniz Universitesi Tıp Fakultesi ( Site 1901)

Antalya, , Turkey (Türkiye)

Site Status

Uludag Universitesi Tip Fakultesi ( Site 1904)

Bursa, , Turkey (Türkiye)

Site Status

Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1900)

Istanbul, , Turkey (Türkiye)

Site Status

Bakirkoy Sadi Konuk Egitim ve Arastirma Hastanesi ( Site 1907)

Istanbul, , Turkey (Türkiye)

Site Status

Medipol Universite Hastanesi ( Site 1909)

Istanbul, , Turkey (Türkiye)

Site Status

Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 1906)

Sakarya, , Turkey (Türkiye)

Site Status

MI Precarpathian Clinical Oncology Center ( Site 2181)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Site Status

Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2180)

Kharkiv, Kharkivs’ka Oblast’, Ukraine

Site Status

Municipal non-profit Enterprise Khmelnytskyi Regional Antitu-Gynecological Oncology department, Poli

Khmelnytskyi, Khmelnytskyi Oblast, Ukraine

Site Status

Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2170)

Lviv, Lviv Oblast, Ukraine

Site Status

MI Odessa Regional Oncological Centre ( Site 2121)

Odesa, Odesa Oblast, Ukraine

Site Status

RMI - Sumy Regional Clinical Oncology Dispensary ( Site 2191)

Sumy, Sumska Oblast, Ukraine

Site Status

Central City Clinical Hospital ( Site 2150)

Uzhhorod, Zakarpattia Oblast, Ukraine

Site Status

Kyiv City Clinical Oncological Center ( Site 2140)

Kyiv, , Ukraine

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Belgium Brazil Canada Chile Colombia Czechia France Germany Hungary Israel Italy Japan Poland Russia South Africa South Korea Spain Taiwan Turkey (Türkiye) Ukraine

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ENGOT-ov43

Identifier Type: OTHER

Identifier Source: secondary_id

MK-7339-001

Identifier Type: OTHER

Identifier Source: secondary_id

KEYLYNK-001

Identifier Type: OTHER

Identifier Source: secondary_id

194619

Identifier Type: REGISTRY

Identifier Source: secondary_id

GOG-3036

Identifier Type: OTHER

Identifier Source: secondary_id

2022-502124-52-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1283-3793

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-001973-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

7339-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Platine, Avastin and OLAparib in 1st Line
NCT02477644 COMPLETED PHASE3