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)

NCT03740165 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 9 other identifiers: 7339-001ENGOT-ov43MK-7339-001KEYLYNK-001194619GOG-30362022-502124-52-00U1111-1283-37932018-001973-25
• Study Type: interventional
• Target: 1,367
• Locations: 22 countries
• Sites: 227

Brief 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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Neoplasms

Keywords

Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1)

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS]≥10)

  PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be reported for participants with PD-L1 positive tumors (CPS≥10). PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

  Up to approximately 67 months

• PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants

  PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be reported for all participants. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

  Up to approximately 67 months

Secondary Outcomes (20)

• Overall Survival (OS) in Participants With PD-L1 Positive Tumors (CPS ≥ 10)

  Up to approximately 67 months

• OS in All Participants

  Up to approximately 67 months

• PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR) in Participants With PD-L1 Positive Tumors (CPS≥10)

  Up to approximately 66 months

• PFS Per RECIST 1.1 as Assessed by BICR in All Participants

  Up to approximately 66 months

• PFS After Second-line Treatment (PFS2) Following Discontinuation of Study Treatment as Assessed by the Investigator in Participants With PD-L1 Positive Tumors (CPS≥10)

  Up to approximately 67 months

Study Arms (3)

Carboplatin + Paclitaxel + Pembrolizumab + Olaparib

EXPERIMENTAL

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.

Biological: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Olaparib; Biological: Bevacizumab; Drug: Docetaxel

Carboplatin + Paclitaxel + Pembrolizumab

EXPERIMENTAL

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.

Biological: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Placebo for olaparib; Biological: Bevacizumab; Drug: Docetaxel

Carboplatin + Paclitaxel

ACTIVE COMPARATOR

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.

Drug: Placebo for pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Placebo for olaparib; Biological: Bevacizumab; Drug: Docetaxel

Interventions

Pembrolizumab BIOLOGICAL

IV infusion

Also known as: MK-3475, KEYTRUDA®

Carboplatin + Paclitaxel + Pembrolizumab; Carboplatin + Paclitaxel + Pembrolizumab + Olaparib

Placebo for pembrolizumab DRUG

IV infusion

Also known as: normal saline or dextrose

Carboplatin + Paclitaxel

Carboplatin DRUG

IV infusion

Also known as: PARAPLATIN®

Carboplatin + Paclitaxel; Carboplatin + Paclitaxel + Pembrolizumab; Carboplatin + Paclitaxel + Pembrolizumab + Olaparib

Paclitaxel DRUG

IV infusion

Also known as: TAXOL®

Carboplatin + Paclitaxel; Carboplatin + Paclitaxel + Pembrolizumab; Carboplatin + Paclitaxel + Pembrolizumab + Olaparib

Olaparib DRUG

Oral tablet

Also known as: MK-7339, LYNPARZA®

Carboplatin + Paclitaxel + Pembrolizumab + Olaparib

Placebo for olaparib DRUG

Oral tablet

Carboplatin + Paclitaxel; Carboplatin + Paclitaxel + Pembrolizumab

Bevacizumab BIOLOGICAL

IV infusion

Also known as: AVASTIN®

Carboplatin + Paclitaxel; Carboplatin + Paclitaxel + Pembrolizumab; Carboplatin + Paclitaxel + Pembrolizumab + Olaparib

Docetaxel DRUG

IV infusion

Carboplatin + Paclitaxel; Carboplatin + Paclitaxel + Pembrolizumab; Carboplatin + Paclitaxel + Pembrolizumab + Olaparib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• European Network of Gynaecological Oncological Trial Groups (ENGOT): collaborator
• Gynecologic Oncology Group: collaborator

Study Sites (227)

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

Birmingham, Alabama, 35233, United States

Location

University of Arizona Cancer Center ( Site 0074)

Tucson, Arizona, 85719, United States

Location

Disney Family Cancer Center ( Site 0042)

Burbank, California, 91505, United States

Location

Kaiser Permanente Oncology Clinical Trial -Oakland ( Site 0077)

Oakland, California, 94611, United States

Location

Kaiser Permanente Oncology Clinical Trials-Roseville ( Site 0084)

Roseville, California, 95661, United States

Location

Kaiser Permanente Oncology Clinical Trials-Sacramento ( Site 0083)

Sacramento, California, 95814, United States

Location

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

San Francisco, California, 94115, United States

Location

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

Santa Clara, California, 95051, United States

Location

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

Vallejo, California, 94589, United States

Location

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

Walnut Creek, California, 94596, United States

Location

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

New Haven, Connecticut, 06511, United States

Location

Sarasota Memorial Hospital ( Site 0023)

Sarasota, Florida, 34239, United States

Location

Emory School of Medicine ( Site 0053)

Atlanta, Georgia, 30322, United States

Location

Northeast Georgia Medical Center ( Site 0029)

Gainesville, Georgia, 30501, United States

Location

Memorial Health University Medical Center ( Site 0011)

Savannah, Georgia, 31404, United States

Location

Rush University Medical Center ( Site 0019)

Chicago, Illinois, 60612, United States

Location

University of Chicago ( Site 0049)

Chicago, Illinois, 60637, United States

Location

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

Hinsdale, Illinois, 60521, United States

Location

Saint Vincent Hospital and Health Center ( Site 0012)

Indianapolis, Indiana, 46260, United States

Location

University of Iowa Hospital and Clinics ( Site 0005)

Iowa City, Iowa, 52242, United States

Location

University of Kentucky ( Site 0045)

Lexington, Kentucky, 40536, United States

Location

Weinberg Cancer Institute at Franklin Square ( Site 0035)

Baltimore, Maryland, 21237, United States

Location

Saint Dominic - Jackson Memorial Hospital ( Site 0072)

Jackson, Mississippi, 39216, United States

Location

Washington University - School of Medicine ( Site 0062)

St Louis, Missouri, 63110, United States

Location

Nebraska Methodist Hospital ( Site 0063)

Omaha, Nebraska, 68114, United States

Location

Dartmouth Hitchcock Medical Center ( Site 0024)

Lebanon, New Hampshire, 03756, United States

Location

MD Anderson Cancer Center at Cooper ( Site 0067)

Camden, New Jersey, 08103, United States

Location

Holy Name Medical Center ( Site 0037)

Teaneck, New Jersey, 07666, United States

Location

Northwell Health- Monter Cancer Center ( Site 0075)

Lake Success, New York, 11042, United States

Location

Sanford Roger Maris Cancer Center ( Site 0082)

Fargo, North Dakota, 58122, United States

Location

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

Centerville, Ohio, 45459, United States

Location

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

Cincinnati, Ohio, 45242, United States

Location

The Bing Cancer Center ( Site 0044)

Columbus, Ohio, 43214, United States

Location

OSU Wexner Medical Center ( Site 0076)

Hilliard, Ohio, 43026, United States

Location

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

Providence, Rhode Island, 02905, United States

Location

Sanford Gynecology Oncology ( Site 0004)

Sioux Falls, South Dakota, 57104, United States

Location

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

Bedford, Texas, 76022, United States

Location

Texas Oncology-Dallas Presbyterian Hospital ( Site 8004)

Dallas, Texas, 75231, United States

Location

Parkland Hospital ( Site 0081)

Dallas, Texas, 75235, United States

Location

UT Southwestern Medical Center ( Site 0046)

Dallas, Texas, 75390, United States

Location

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

Tyler, Texas, 75702, United States

Location

Virginia Cancer Specialists, PC ( Site 8003)

Gainesville, Virginia, 20155, United States

Location

MEDICAL COLLEGE OF WISCONSIN ( Site 0064)

Milwaukee, Wisconsin, 53226, United States

Location

St George Hospital ( Site 2207)

Kogarah, New South Wales, 2217, Australia

Location

Cairns and Hinterland Hospital and Health Service ( Site 2201)

Cairns, Queensland, 4870, Australia

Location

Ballarat Health Services ( Site 2202)

Ballarat, Victoria, 3350, Australia

Location

Monash Health ( Site 2204)

Clayton, Victoria, 3168, Australia

Location

Sunshine Hospital. ( Site 2205)

St Albans, Victoria, 3021, Australia

Location

Imelda Ziekenhuis Bonheiden ( Site 0301)

Bonheiden, Antwerpen, 1932, Belgium

Location

UZ Leuven Campus Gasthuisberg ( Site 0306)

Leuven, Antwerpen, 3000, Belgium

Location

Cliniques Universitaires Saint-Luc ( Site 0312)

Brussels, Bruxelles-Capitale, Region de, 1200, Belgium

Location

Grand Hopital de Charleroi ( Site 0302)

Charleroi, Hainaut, 6000, Belgium

Location

CHU de Liege ( Site 0310)

Liège, Liege, 4000, Belgium

Location

Jessa Ziekenhuis ( Site 0309)

Hasselt, Limburg, 3500, Belgium

Location

Centre Hospitalier de l'Ardenne ( Site 0303)

Libramont, Luxembourg, 6800, Belgium

Location

AZ Maria Middelares Gent ( Site 0300)

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ Gent ( Site 0307)

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Instituto do Cancer do Ceara ( Site 2707)

Fortaleza, Ceará, 60430-230, Brazil

Location

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

Goiânia, Goiás, 74605-070, Brazil

Location

Hospital Erasto Gaertner ( Site 2716)

Curitiba, Paraná, 82520-060, Brazil

Location

Hospital de Caridade de Ijui ( Site 2712)

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Hospital Bruno Born ( Site 2704)

Lajeado, Rio Grande do Sul, 95900-000, Brazil

Location

Hospital Nossa Senhora Da Conceicao ( Site 2703)

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

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

Rio de Janeiro, 20220-410, Brazil

Location

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

São Paulo, 01246-000, Brazil

Location

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

São Paulo, 01317-000, Brazil

Location

Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2710)

São Paulo, 01321-001, Brazil

Location

Tom Baker Cancer Centre ( Site 0200)

Calgary, Alberta, T2N 4N2, Canada

Location

Kingston Health Sciences Centre ( Site 0207)

Kingston, Ontario, K7L 2V7, Canada

Location

The Credit Valley Hospital ( Site 0206)

Mississauga, Ontario, L5M 2N1, Canada

Location

Princess Margaret Hospital.. ( Site 0202)

Toronto, Ontario, M5G 2M9, Canada

Location

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

Chicoutimi, Quebec, G7H 5H6, Canada

Location

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

Montreal, Quebec, H1T 2M4, Canada

Location

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

Montreal, Quebec, H2X 0A9, Canada

Location

Royal Victoria Hospital McGill University Health Centre ( Site 0211)

Montreal, Quebec, H4A 3J1, Canada

Location

Fundacion Arturo Lopez Perez FALP ( Site 2800)

Santiago, Region M. de Santiago, 7500922, Chile

Location

Sociedad Oncovida S.A. ( Site 2807)

Santiago, Region M. de Santiago, 7510032, Chile

Location

Iram Cancer Research ( Site 2809)

Santiago, Region M. de Santiago, 7630370, Chile

Location

Pontificia Universidad Catolica de Chile ( Site 2805)

Santiago, Region M. de Santiago, 8330032, Chile

Location

Centro Investigación del Cáncer James Lind ( Site 2810)

Temuco, Región de la Araucanía, 4780000, Chile

Location

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

Temuco, Región de la Araucanía, 4810218, Chile

Location

Oncocentro ( Site 2801)

Viña del Mar, Región de Valparaíso, 2520598, Chile

Location

Centro Oncologico Antofagasta ( Site 2804)

Antofagasta, 1240000, Chile

Location

Biomelab S A S ( Site 2900)

Barranquilla, Atlántico, 080002, Colombia

Location

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

Bogotá, Bogota D.C., 110321, Colombia

Location

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

Bogotá, Bogota D.C., 111321, Colombia

Location

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

Valledupar, Cesar Department, 200001, Colombia

Location

Oncomedica S.A. ( Site 2911)

Montería, Departamento de Córdoba, 230002, Colombia

Location

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

Cali, Valle del Cauca Department, 760042, Colombia

Location

Hemato Oncologos S.A. ( Site 2906)

Cali, Valle del Cauca Department, 760042, Colombia

Location

Fakultni nemocnice Brno ( Site 0404)

Brno, Brno-mesto, 602 00, Czechia

Location

Fakultni nemocnice Ostrava ( Site 0403)

Ostrava-Poruba, Moravskoslezský kraj, 708 52, Czechia

Location

Vseobecna fakultni nemocnice v Praze ( Site 0400)

Prague, Praha, Hlavni Mesto, 120 00, Czechia

Location

Nemocnice Na Bulovce ( Site 0401)

Prague, Praha, Hlavni Mesto, 180 81, Czechia

Location

Fakultni nemocnice Olomouc ( Site 0402)

Olomouc, 779 00, Czechia

Location

Hopital Prive Jean Mermoz ( Site 0607)

Lyon, Auvergne, 69008, France

Location

Centre Paul Strauss ( Site 0615)

Strasbourg, Bas-Rhin, 67065, France

Location

Hopital de la Timone ( Site 0617)

Marseille, Bouches-du-Rhone, 13005, France

Location

CHU de Brest -Site Hopital Morvan ( Site 0616)

Brest, Brittany Region, 29200, France

Location

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

Nîmes, Gard, 30029, France

Location

Centre D Oncologie de Gentilly ( Site 0609)

Nancy, Meurthe-et-Moselle, 54100, France

Location

Institut de Cancerologie Lucien Neuwirth ( Site 0613)

Saint-Priest-en-Jarez, Pays de la Loire Region, 42270, France

Location

Institut Gustave Roussy ( Site 0600)

Villejuif, Val-de-Marne, 94800, France

Location

Hopital Tenon ( Site 0612)

Paris, 75020, France

Location

Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0707)

Stuttgart, Baden-Wurttemberg, 70199, Germany

Location

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

Munich, Bavaria, 72074, Germany

Location

Uniklinik RWTH Aachen ( Site 0718)

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Gynaekologisches Zentrum ( Site 0712)

Bonn, North Rhine-Westphalia, 53111, Germany

Location

Klinikum Dortmund gGmbH ( Site 0717)

Dortmund, North Rhine-Westphalia, 44137, Germany

Location

Universitaetsklinikum Duesseldorf ( Site 0704)

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

HELIOS Klinikum Krefeld ( Site 0715)

Krefeld, North Rhine-Westphalia, 47805, Germany

Location

Universitaetsklinikum Muenster ( Site 0720)

Münster, North Rhine-Westphalia, 48149, Germany

Location

Caritas Klinikum Saarbruecken St. Theresia ( Site 0702)

Saarbrücken, Saarland, 66113, Germany

Location

Klinikum Chemnitz gGmbH ( Site 0711)

Chemnitz, Saxony, 09116, Germany

Location

Staedtisches Krankenhaus Kiel GmbH ( Site 0709)

Kiel, Schleswig-Holstein, 24116, Germany

Location

Charite Campus Virchow-Klinikum - CVK ( Site 0700)

Berlin, 13353, Germany

Location

Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 0805)

Pécs, Baranya, 7624, Hungary

Location

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

Miskolc, Borsod-Abauj Zemplen county, 1051, Hungary

Location

Orszagos Onkologiai Intezet ( Site 0800)

Budapest, 1122, Hungary

Location

Uzsoki Utcai Korhaz ( Site 0803)

Budapest, 1145, Hungary

Location

Debreceni Egyetem Klinikai Kozpont ( Site 0801)

Debrecen, 4032, Hungary

Location

Soroka Medical Center ( Site 1006)

Beersheba, 8410101, Israel

Location

Hillel Yaffe Medical Center ( Site 1011)

Hadera, 3810101, Israel

Location

Carmel Medical Center ( Site 1007)

Haifa, 3436212, Israel

Location

Rambam Medical Center ( Site 1002)

Haifa, 3525408, Israel

Location

Edith Wolfson Medical Center ( Site 1003)

Holon, 5822012, Israel

Location

Shaare Zedek Medical Center ( Site 1005)

Jerusalem, 9103102, Israel

Location

Rabin Medical Center ( Site 1004)

Petah Tikva, 4941492, Israel

Location

Chaim Sheba Medical Center ( Site 1000)

Ramat Gan, 5262000, Israel

Location

Sourasky Medical Center ( Site 1001)

Tel Aviv, 6423906, Israel

Location

IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1108)

Bari, Abruzzo, 70124, Italy

Location

Istituto Europeo di Oncologia ( Site 1100)

Milan, Lombardy, 20141, Italy

Location

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

Turin, Piedmont, 10126, Italy

Location

Istituto Oncologico Veneto IRCCS ( Site 1113)

Padua, Veneto, 35128, Italy

Location

Sacro Cuore di Gesu Fatebenefratelli ( Site 1112)

Benevento, 82100, Italy

Location

Ospedale Cannizzaro ( Site 1110)

Catania, 95126, Italy

Location

ASST Lecco. Ospedale A. Manzoni ( Site 1101)

Lecco, 23900, Italy

Location

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

Milan, 20133, Italy

Location

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

Napoli, 80131, Italy

Location

Azienda Ospedaliera Policlinico Umberto I ( Site 1111)

Roma, 00161, Italy

Location

Policlinico Universitario Gemelli ( Site 1105)

Roma, 00168, Italy

Location

Presidio Ospedaliero Santa Chiara ( Site 1109)

Trento, 38122, Italy

Location

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

Udine, 33100, Italy

Location

National Cancer Center Hospital East ( Site 2602)

Kashiwa, Chiba, 277-8577, Japan

Location

National Hospital Organization Shikoku Cancer Center ( Site 2601)

Matsuyama, Ehime, 791-0280, Japan

Location

Ehime University Hospital ( Site 2600)

Tōon, Ehime, 791-0295, Japan

Location

Gunma Prefectural Cancer Center ( Site 2609)

Ōta, Gunma, 373-8550, Japan

Location

Hokkaido University Hospital ( Site 2607)

Sapporo, Hokkaido, 060-8648, Japan

Location

Iwate Medical University Hospital ( Site 2606)

Shiwa-gun, Iwate, 028-3695, Japan

Location

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

Kawasaki, Kanagawa, 216-8511, Japan

Location

University of the Ryukyus Hospital ( Site 2616)

Nakagami-gun, Okinawa, 903-0215, Japan

Location

Saitama Medical University International Medical Center ( Site 2604)

Hidaka, Saitama, 350-1298, Japan

Location

Saitama Cancer Center ( Site 2614)

Kitaadachi-gun, Saitama, 362-0806, Japan

Location

National Defense Medical College Hospital ( Site 2608)

Tokorozawa, Saitama, 359-8513, Japan

Location

Kyorin University Hospital ( Site 2610)

Mitaka, Tokyo, 181-8611, Japan

Location

Kagoshima City Hospital ( Site 2612)

Kagoshima, 890-8760, Japan

Location

Niigata Cancer Center Hospital ( Site 2618)

Niigata, 951-8566, Japan

Location

Osaka International Cancer Institute ( Site 2617)

Osaka, 541-8567, Japan

Location

National Cancer Center Hospital ( Site 2605)

Tokyo, 104-0045, Japan

Location

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

Poznan, Greater Poland Voivodeship, 61-848, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Bialostockie Centrum Onkologii ( Site 1412)

Bialystok, Podlaskie Voivodeship, 15-027, Poland

Location

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

Gdynia, Pomeranian Voivodeship, 81-519, Poland

Location

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1406)

Gliwice, Silesian Voivodeship, 44-102, Poland

Location

Swietokrzyskie Centrum Onkologii SPZOZ ( Site 1410)

Kielce, Świętokrzyskie Voivodeship, 25-734, Poland

Location

Arkhangelsk Clinical Oncological Dispensary ( Site 1508)

Arkhangelsk, Arkhangelskaya oblast, 163045, Russia

Location

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

Ufa, Baskortostan, Respublika, 450054, Russia

Location

A. Tsyb Medical Radiological Research Center ( Site 1513)

Obninsk, Kaluzskaja Oblast, 249036, Russia

Location

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

Moscow, Moscow, 115478, Russia

Location

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

Moscow, Moscow, 115682, Russia

Location

Medical Rehabilitation Center ( Site 1502)

Moscow, Moscow, 125367, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

City Clinical Oncology Center ( Site 1505)

Saint Petersburg, Sankt-Peterburg, 198255, Russia

Location

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1509)

Kazan', Tatarstan, Respublika, 420029, Russia

Location

Cancer Care Langenhoven Drive Oncology Centre ( Site 1701)

Port Elizabeth, Eastern Cape, 6045, South Africa

Location

Groote Schuur Hospital ( Site 1704)

Cape Town, Gauteng, 7925, South Africa

Location

Wits Clinical Research ( Site 1702)

Johannesburg, Gauteng, 2193, South Africa

Location

Department of Medical Oncology ( Site 1703)

Pretoria, Gauteng, 0002, South Africa

Location

Curo Oncology ( Site 1710)

Pretoria, Gauteng, 0031, South Africa

Location

Wilgers Oncology Centre ( Site 1705)

Pretoria, Gauteng, 0081, South Africa

Location

Little Company of Mary Hospital ( Site 1700)

Pretoria, Gauteng, 0181, South Africa

Location

Sandton Oncology Medical Group PTY LTD ( Site 1712)

Sandton, Gauteng, 2196, South Africa

Location

The Oncology Centre ( Site 1709)

Durban, KwaZulu-Natal, 4091, South Africa

Location

Cancercare ( Site 1706)

Cape Town, Western Cape, 7700, South Africa

Location

Outeniqua Cancercare Oncology Unit ( Site 1708)

George, Western Cape, 6530, South Africa

Location

Cape Town Oncology Trials Pty Ltd ( Site 1707)

Kraaifontein, Western Cape, 7570, South Africa

Location

Seoul National University Bundang Hospital ( Site 2404)

Seongnam-si, Kyonggi-do, 13620, South Korea

Location

Seoul National University Hospital ( Site 2403)

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System ( Site 2400)

Seoul, 03722, South Korea

Location

Asan Medical Center ( Site 2402)

Seoul, 05505, South Korea

Location

Samsung Medical Center ( Site 2401)

Seoul, 06351, South Korea

Location

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

L'Hospitalet de Llobregat, Barcelona, 08909, Spain

Location

Xarxa Assistencial Universitaria Manresa ( Site 1605)

Manresa, Barcelona, 08243, Spain

Location

Hospital de Terrassa ( Site 1606)

Terrassa, Barcelona, 08227, Spain

Location

Hospital Universitario de Donostia ( Site 1602)

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

Location

Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1608)

A Coruña, La Coruna, 15006, Spain

Location

Instituto Valenciano de Oncologia ( Site 1601)

Valencia, Valenciana, Comunitat, 46009, Spain

Location

Hospital General Universitario de Valencia ( Site 1610)

Valencia, Valenciana, Comunitat, 46014, Spain

Location

Hospital Provincial San Pedro de Alcantara ( Site 1607)

Cáceres, 10003, Spain

Location

Hospital Universitario Lucus Augusti ( Site 1609)

Lugo, 27003, Spain

Location

Clinica Universitaria de Navarra ( Site 1600)

Madrid, 28027, Spain

Location

Hospital Universitario Virgen del Rocio ( Site 1604)

Seville, 41013, Spain

Location

Changhua Christian Hospital ( Site 2507)

Changhua, 50006, Taiwan

Location

China Medical University Hospital ( Site 2506)

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital ( Site 2510)

Taichung, 40705, Taiwan

Location

National Cheng Kung University Hospital ( Site 2508)

Tainan, 704, Taiwan

Location

National Taiwan University Hospital ( Site 2502)

Taipei, 10002, Taiwan

Location

MacKay Memorial Hospital ( Site 2500)

Taipei, 10449, Taiwan

Location

Taipei Veterans General Hospital ( Site 2503)

Taipei, 11217, Taiwan

Location

Linkou Chang Gung Memorial Hospital ( Site 2501)

Taoyuan District, 333, Taiwan

Location

Istanbul Acibadem University Atakent Hospital ( Site 1902)

Küçükçekmece, Istanbul, 34303, Turkey (Türkiye)

Location

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

Ankara, 06050, Turkey (Türkiye)

Location

Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 1905)

Ankara, 06590, Turkey (Türkiye)

Location

Akdeniz Universitesi Tıp Fakultesi ( Site 1901)

Antalya, 07070, Turkey (Türkiye)

Location

Uludag Universitesi Tip Fakultesi ( Site 1904)

Bursa, 16059, Turkey (Türkiye)

Location

Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1900)

Istanbul, 34093, Turkey (Türkiye)

Location

Bakirkoy Sadi Konuk Egitim ve Arastirma Hastanesi ( Site 1907)

Istanbul, 34147, Turkey (Türkiye)

Location

Medipol Universite Hastanesi ( Site 1909)

Istanbul, 34214, Turkey (Türkiye)

Location

Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 1906)

Sakarya, 54290, Turkey (Türkiye)

Location

MI Precarpathian Clinical Oncology Center ( Site 2181)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

Location

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

Kharkiv, Kharkivs’ka Oblast’, 61024, Ukraine

Location

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

Khmelnytskyi, Khmelnytskyi Oblast, 29009, Ukraine

Location

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

Lviv, Lviv Oblast, 79031, Ukraine

Location

MI Odessa Regional Oncological Centre ( Site 2121)

Odesa, Odesa Oblast, 65055, Ukraine

Location

RMI - Sumy Regional Clinical Oncology Dispensary ( Site 2191)

Sumy, Sumska Oblast, 40022, Ukraine

Location

Central City Clinical Hospital ( Site 2150)

Uzhhorod, Zakarpattia Oblast, 88000, Ukraine

Location

Kyiv City Clinical Oncological Center ( Site 2140)

Kyiv, 03115, Ukraine

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; Saline Solution; Glucose; Carboplatin; Paclitaxel; olaparib; Bevacizumab; Docetaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Hexoses; Monosaccharides; Sugars; Carbohydrates; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 14, 2018
• Study Start: December 18, 2018
• Primary Completion: August 26, 2024
• Study Completion (Estimated): May 29, 2026
• Last Updated: October 22, 2025
• Results First Posted: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

PL (6); CA (8); ZA (12); ES (11); TW (8); RU (9); TU (9); HU (5); UA (8); FR (9); CZ (5); BR (10); DE (12); JP (16); AU (5); IL (9); US (43); IT (13); CO (7); KR (5); BE (9); CL (8)