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COMPLETED
NCT03740165
PHASE3

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1367

Start Date

2018-12-18

Completion Date

2026-04-14

Last Updated

2026-08-19

Healthy Volunteers

No

Interventions

BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Placebo for pembrolizumab

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Olaparib

Oral tablet

DRUG

Placebo for olaparib

Oral tablet

BIOLOGICAL

Bevacizumab

IV infusion

DRUG

Docetaxel

IV infusion

Locations (227)

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

Birmingham, Alabama, United States

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

Dartmouth Hitchcock Medical Center ( Site 0024)

Lebanon, New Hampshire, United States

MD Anderson Cancer Center at Cooper ( Site 0067)

Camden, New Jersey, United States

Holy Name Medical Center ( Site 0037)

Teaneck, New Jersey, United States

Northwell Health- Monter Cancer Center ( Site 0075)

Lake Success, New York, United States

Sanford Roger Maris Cancer Center ( Site 0082)

Fargo, North Dakota, United States

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

Centerville, Ohio, United States

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

Cincinnati, Ohio, United States

The Bing Cancer Center ( Site 0044)

Columbus, Ohio, United States

OSU Wexner Medical Center ( Site 0076)

Hilliard, Ohio, United States

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

Providence, Rhode Island, United States

Sanford Gynecology Oncology ( Site 0004)

Sioux Falls, South Dakota, United States

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

Bedford, Texas, United States

Texas Oncology-Dallas Presbyterian Hospital ( Site 8004)

Dallas, Texas, United States

Parkland Hospital ( Site 0081)

Dallas, Texas, United States

UT Southwestern Medical Center ( Site 0046)

Dallas, Texas, United States

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

Tyler, Texas, United States

Virginia Cancer Specialists, PC ( Site 8003)

Gainesville, Virginia, United States

MEDICAL COLLEGE OF WISCONSIN ( Site 0064)

Milwaukee, Wisconsin, United States

St George Hospital ( Site 2207)

Kogarah, New South Wales, Australia

Cairns and Hinterland Hospital and Health Service ( Site 2201)

Cairns, Queensland, Australia

Ballarat Health Services ( Site 2202)

Ballarat, Victoria, Australia

Monash Health ( Site 2204)

Clayton, Victoria, Australia

Sunshine Hospital. ( Site 2205)

St Albans, Victoria, Australia

Imelda Ziekenhuis Bonheiden ( Site 0301)

Bonheiden, Antwerpen, Belgium

UZ Leuven Campus Gasthuisberg ( Site 0306)

Leuven, Antwerpen, Belgium

Cliniques Universitaires Saint-Luc ( Site 0312)

Brussels, Bruxelles-Capitale, Region de, Belgium

Grand Hopital de Charleroi ( Site 0302)

Charleroi, Hainaut, Belgium

CHU de Liege ( Site 0310)

Liège, Liege, Belgium

Jessa Ziekenhuis ( Site 0309)

Hasselt, Limburg, Belgium

Centre Hospitalier de l'Ardenne ( Site 0303)

Libramont, Luxembourg, Belgium

AZ Maria Middelares Gent ( Site 0300)

Ghent, Oost-Vlaanderen, Belgium

UZ Gent ( Site 0307)

Ghent, Oost-Vlaanderen, Belgium

Instituto do Cancer do Ceara ( Site 2707)

Fortaleza, Ceará, Brazil

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

Goiânia, Goiás, Brazil

Hospital Erasto Gaertner ( Site 2716)

Curitiba, Paraná, Brazil

Hospital de Caridade de Ijui ( Site 2712)

Ijuí, Rio Grande do Sul, Brazil

Hospital Bruno Born ( Site 2704)

Lajeado, Rio Grande do Sul, Brazil

Hospital Nossa Senhora Da Conceicao ( Site 2703)

Porto Alegre, Rio Grande do Sul, Brazil

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

Rio de Janeiro, Brazil

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

São Paulo, Brazil

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

São Paulo, Brazil

Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2710)

São Paulo, Brazil

Tom Baker Cancer Centre ( Site 0200)

Calgary, Alberta, Canada

Kingston Health Sciences Centre ( Site 0207)

Kingston, Ontario, Canada

The Credit Valley Hospital ( Site 0206)

Mississauga, Ontario, Canada

Princess Margaret Hospital.. ( Site 0202)

Toronto, Ontario, Canada

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

Chicoutimi, Quebec, Canada

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

Montreal, Quebec, Canada

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

Montreal, Quebec, Canada

Royal Victoria Hospital McGill University Health Centre ( Site 0211)

Montreal, Quebec, Canada

Centro Investigación del Cáncer James Lind ( Site 2810)

Temuco, Araucania, Chile

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

Temuco, Araucania, Chile

Fundacion Arturo Lopez Perez FALP ( Site 2800)

Santiago, Region M. de Santiago, Chile

Sociedad Oncovida S.A. ( Site 2807)

Santiago, Region M. de Santiago, Chile

Iram Cancer Research ( Site 2809)

Santiago, Region M. de Santiago, Chile

Pontificia Universidad Catolica de Chile ( Site 2805)

Santiago, Region M. de Santiago, Chile

Oncocentro ( Site 2801)

Viña del Mar, Valparaiso, Chile

Centro Oncologico Antofagasta ( Site 2804)

Antofagasta, Chile

Biomelab S A S ( Site 2900)

Barranquilla, Atlántico, Colombia

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

Bogotá, Bogota D.C., Colombia

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

Bogotá, Bogota D.C., Colombia

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

Valledupar, Cesar Department, Colombia

Oncomedica S.A. ( Site 2911)

Montería, Departamento de Córdoba, Colombia

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

Cali, Valle del Cauca Department, Colombia

Hemato Oncologos S.A. ( Site 2906)

Cali, Valle del Cauca Department, Colombia

Fakultni nemocnice Brno ( Site 0404)

Brno, Brno-mesto, Czechia

Fakultni nemocnice Ostrava ( Site 0403)

Ostrava-Poruba, Moravian-Silesian Region, Czechia

Vseobecna fakultni nemocnice v Praze ( Site 0400)

Prague, Praha, Hlavni Mesto, Czechia

Nemocnice Na Bulovce ( Site 0401)

Prague, Praha, Hlavni Mesto, Czechia

Fakultni nemocnice Olomouc ( Site 0402)

Olomouc, Czechia

Hopital Prive Jean Mermoz ( Site 0607)

Lyon, Auvergne, France

Centre Paul Strauss ( Site 0615)

Strasbourg, Bas-Rhin, France

Hopital de la Timone ( Site 0617)

Marseille, Bouches-du-Rhone, France

CHU de Brest -Site Hopital Morvan ( Site 0616)

Brest, Brittany Region, France

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

Nîmes, Gard, France

And 127 more locations on ClinicalTrials.gov