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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
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
Pembrolizumab
IV infusion
Placebo for pembrolizumab
IV infusion
Carboplatin
IV infusion
Paclitaxel
IV infusion
Olaparib
Oral tablet
Placebo for olaparib
Oral tablet
Bevacizumab
IV infusion
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