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)

April 30, 2026 updated by: Merck Sharp & Dohme LLC

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

1367

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • St George Hospital ( Site 2207)
    • Queensland
      • Cairns, Queensland, Australia, 4870
        • Cairns and Hinterland Hospital and Health Service ( Site 2201)
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • Ballarat Health Services ( Site 2202)
      • Clayton, Victoria, Australia, 3168
        • Monash Health ( Site 2204)
      • St Albans, Victoria, Australia, 3021
        • Sunshine Hospital. ( Site 2205)
  • Belgium
    • Antwerpen
      • Bonheiden, Antwerpen, Belgium, 1932
        • Imelda Ziekenhuis Bonheiden ( Site 0301)
      • Leuven, Antwerpen, Belgium, 3000
        • UZ Leuven Campus Gasthuisberg ( Site 0306)
    • Bruxelles-Capitale, Region de
      • Brussels, Bruxelles-Capitale, Region de, Belgium, 1200
        • Cliniques Universitaires Saint-Luc ( Site 0312)
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6000
        • Grand Hopital de Charleroi ( Site 0302)
    • Liege
      • Liège, Liege, Belgium, 4000
        • CHU de Liege ( Site 0310)
    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Jessa Ziekenhuis ( Site 0309)
    • Luxembourg
      • Libramont, Luxembourg, Belgium, 6800
        • Centre Hospitalier de l'Ardenne ( Site 0303)
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • AZ Maria Middelares Gent ( Site 0300)
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent ( Site 0307)
  • Brazil
      • Rio de Janeiro, Brazil, 20220-410
        • Instituto Nacional de Cancer Hospital do Cancer II ( Site 2700)
      • São Paulo, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 2714)
      • São Paulo, Brazil, 01317-000
        • Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706)
      • São Paulo, Brazil, 01321-001
        • Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2710)
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-230
        • Instituto do Cancer do Ceara ( Site 2707)
    • Goiás
      • Goiânia, Goiás, Brazil, 74605-070
        • Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2708)
    • Paraná
      • Curitiba, Paraná, Brazil, 82520-060
        • Hospital Erasto Gaertner ( Site 2716)
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • Hospital de Caridade de Ijui ( Site 2712)
      • Lajeado, Rio Grande do Sul, Brazil, 95900-000
        • Hospital Bruno Born ( Site 2704)
      • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
        • Hospital Nossa Senhora Da Conceicao ( Site 2703)
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre ( Site 0200)
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Health Sciences Centre ( Site 0207)
      • Mississauga, Ontario, Canada, L5M 2N1
        • The Credit Valley Hospital ( Site 0206)
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital.. ( Site 0202)
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • CIUSSS du Saguenay-Lac-St-Jean ( Site 0218)
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0219)
      • Montreal, Quebec, Canada, H2X 0A9
        • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0208)
      • Montreal, Quebec, Canada, H4A 3J1
        • Royal Victoria Hospital McGill University Health Centre ( Site 0211)
  • Chile
      • Antofagasta, Chile, 1240000
        • Centro Oncologico Antofagasta ( Site 2804)
    • Araucania
      • Temuco, Araucania, Chile, 4780000
        • Centro Investigación del Cáncer James Lind ( Site 2810)
      • Temuco, Araucania, Chile, 4810218
        • Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 2808)
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500922
        • Fundacion Arturo Lopez Perez FALP ( Site 2800)
      • Santiago, Region M. de Santiago, Chile, 7510032
        • Sociedad Oncovida S.A. ( Site 2807)
      • Santiago, Region M. de Santiago, Chile, 7630370
        • Iram Cancer Research ( Site 2809)
      • Santiago, Region M. de Santiago, Chile, 8330032
        • Pontificia Universidad Catolica de Chile ( Site 2805)
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Oncocentro ( Site 2801)
  • Colombia
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080002
        • Biomelab S A S ( Site 2900)
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 110321
        • Instituto Nacional de Cancerologia E.S.E ( Site 2910)
      • Bogotá, Bogota D.C., Colombia, 111321
        • Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2912)
    • Cesar Department
      • Valledupar, Cesar Department, Colombia, 200001
        • Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2913)
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230002
        • Oncomedica S.A. ( Site 2911)
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760042
        • Centro Medico Imbanaco de Cali S.A ( Site 2909)
      • Cali, Valle del Cauca Department, Colombia, 760042
        • Hemato Oncologos S.A. ( Site 2906)
  • Czechia
      • Olomouc, Czechia, 779 00
        • Fakultni nemocnice Olomouc ( Site 0402)
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 602 00
        • Fakultni nemocnice Brno ( Site 0404)
    • Moravian-Silesian Region
      • Ostrava-Poruba, Moravian-Silesian Region, Czechia, 708 52
        • Fakultni nemocnice Ostrava ( Site 0403)
    • Praha, Hlavni Mesto
      • Prague, Praha, Hlavni Mesto, Czechia, 120 00
        • Vseobecna fakultni nemocnice v Praze ( Site 0400)
      • Prague, Praha, Hlavni Mesto, Czechia, 180 81
        • Nemocnice Na Bulovce ( Site 0401)
  • France
      • Paris, France, 75020
        • Hopital Tenon ( Site 0612)
    • Auvergne
      • Lyon, Auvergne, France, 69008
        • Hopital Prive Jean Mermoz ( Site 0607)
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67065
        • Centre Paul Strauss ( Site 0615)
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13005
        • Hopital de la Timone ( Site 0617)
    • Brittany Region
      • Brest, Brittany Region, France, 29200
        • CHU de Brest -Site Hopital Morvan ( Site 0616)
    • Gard
      • Nîmes, Gard, France, 30029
        • Institut de Cancerologie du Gard - CHU Caremeau ( Site 0610)
    • Meurthe-et-Moselle
      • Nancy, Meurthe-et-Moselle, France, 54100
        • Centre D Oncologie de Gentilly ( Site 0609)
    • Pays de la Loire Region
      • Saint-Priest-en-Jarez, Pays de la Loire Region, France, 42270
        • Institut de Cancerologie Lucien Neuwirth ( Site 0613)
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94800
        • Institut Gustave Roussy ( Site 0600)
  • Germany
      • Berlin, Germany, 13353
        • Charite Campus Virchow-Klinikum - CVK ( Site 0700)
    • Baden-Wurttemberg
      • Stuttgart, Baden-Wurttemberg, Germany, 70199
        • Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0707)
    • Bavaria
      • Munich, Bavaria, Germany, 72074
        • Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0710)
    • North Rhine-Westphalia
      • Aachen, North Rhine-Westphalia, Germany, 52074
        • Uniklinik RWTH Aachen ( Site 0718)
      • Bonn, North Rhine-Westphalia, Germany, 53111
        • Gynaekologisches Zentrum ( Site 0712)
      • Dortmund, North Rhine-Westphalia, Germany, 44137
        • Klinikum Dortmund gGmbH ( Site 0717)
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Universitaetsklinikum Duesseldorf ( Site 0704)
      • Krefeld, North Rhine-Westphalia, Germany, 47805
        • HELIOS Klinikum Krefeld ( Site 0715)
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Universitaetsklinikum Muenster ( Site 0720)
    • Saarland
      • Saarbrücken, Saarland, Germany, 66113
        • Caritas Klinikum Saarbruecken St. Theresia ( Site 0702)
    • Saxony
      • Chemnitz, Saxony, Germany, 09116
        • Klinikum Chemnitz gGmbH ( Site 0711)
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24116
        • Staedtisches Krankenhaus Kiel GmbH ( Site 0709)
  • Hungary
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet ( Site 0800)
      • Budapest, Hungary, 1145
        • Uzsoki Utcai Korhaz ( Site 0803)
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont ( Site 0801)
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 0805)
    • Borsod-Abauj Zemplen county
      • Miskolc, Borsod-Abauj Zemplen county, Hungary, 1051
        • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz ( Site 0802)
  • Israel
      • Beersheba, Israel, 8410101
        • Soroka Medical Center ( Site 1006)
      • Hadera, Israel, 3810101
        • Hillel Yaffe Medical Center ( Site 1011)
      • Haifa, Israel, 3436212
        • Carmel Medical Center ( Site 1007)
      • Haifa, Israel, 3525408
        • Rambam Medical Center ( Site 1002)
      • Holon, Israel, 5822012
        • Edith Wolfson Medical Center ( Site 1003)
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center ( Site 1005)
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center ( Site 1004)
      • Ramat Gan, Israel, 5262000
        • Chaim Sheba Medical Center ( Site 1000)
      • Tel Aviv, Israel, 6423906
        • Sourasky Medical Center ( Site 1001)
  • Italy
      • Benevento, Italy, 82100
        • Sacro Cuore di Gesu Fatebenefratelli ( Site 1112)
      • Catania, Italy, 95126
        • Ospedale Cannizzaro ( Site 1110)
      • Lecco, Italy, 23900
        • ASST Lecco. Ospedale A. Manzoni ( Site 1101)
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1115)
      • Naples, Italy, 80131
        • A.O.U. Federico II di Napoli ( Site 1107)
      • Roma, Italy, 00161
        • Azienda Ospedaliera Policlinico Umberto I ( Site 1111)
      • Roma, Italy, 00168
        • Policlinico Universitario Gemelli ( Site 1105)
      • Trento, Italy, 38122
        • Presidio Ospedaliero Santa Chiara ( Site 1109)
      • Udine, Italy, 33100
        • A.O. Univ. S. M. della Misericordia ( Site 1114)
    • Abruzzo
      • Bari, Abruzzo, Italy, 70124
        • IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1108)
    • Lombardy
      • Milan, Lombardy, Italy, 20141
        • Istituto Europeo di Oncologia ( Site 1100)
    • Piedmont
      • Turin, Piedmont, Italy, 10126
        • A.O.U. Citta della Salute e della Scienza di Torino ( Site 1104)
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Istituto Oncologico Veneto IRCCS ( Site 1113)
  • Japan
      • Kagoshima, Japan, 890-8760
        • Kagoshima City Hospital ( Site 2612)
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital ( Site 2618)
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute ( Site 2617)
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital ( Site 2605)
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East ( Site 2602)
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center ( Site 2601)
      • Tōon, Ehime, Japan, 791-0295
        • Ehime University Hospital ( Site 2600)
    • Gunma
      • Ōta, Gunma, Japan, 373-8550
        • Gunma Prefectural Cancer Center ( Site 2609)
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital ( Site 2607)
    • Iwate
      • Shiwa-gun, Iwate, Japan, 028-3695
        • Iwate Medical University Hospital ( Site 2606)
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • St. Marianna University School of Medicine Hospital ( Site 2613)
    • Okinawa
      • Nakagami-gun, Okinawa, Japan, 903-0215
        • University of the Ryukyus Hospital ( Site 2616)
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Saitama Medical University International Medical Center ( Site 2604)
      • Kitaadachi-gun, Saitama, Japan, 362-0806
        • Saitama Cancer Center ( Site 2614)
      • Tokorozawa, Saitama, Japan, 359-8513
        • National Defense Medical College Hospital ( Site 2608)
    • Tokyo
      • Mitaka, Tokyo, Japan, 181-8611
        • Kyorin University Hospital ( Site 2610)
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-848
        • Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-027
        • Bialostockie Centrum Onkologii ( Site 1412)
    • Pomeranian Voivodeship
      • Gdynia, Pomeranian Voivodeship, Poland, 81-519
        • Szpitale Pomorskie Sp. z o.o. ( Site 1407)
    • Silesian Voivodeship
      • Gliwice, Silesian Voivodeship, Poland, 44-102
        • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1406)
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
        • Swietokrzyskie Centrum Onkologii SPZOZ ( Site 1410)
  • Russia
    • Arkhangelskaya oblast
      • Arkhangelsk, Arkhangelskaya oblast, Russia, 163045
        • Arkhangelsk Clinical Oncological Dispensary ( Site 1508)
    • Baskortostan, Respublika
      • Ufa, Baskortostan, Respublika, Russia, 450054
        • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507)
    • Kaluzskaja Oblast
      • Obninsk, Kaluzskaja Oblast, Russia, 249036
        • A. Tsyb Medical Radiological Research Center ( Site 1513)
    • Moscow
      • Moscow, Moscow, Russia, 115478
        • FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1500)
      • Moscow, Moscow, Russia, 115682
        • FSCC of Special Types of Med. Care and Technologies ( Site 1503)
      • Moscow, Moscow, Russia, 125367
        • Medical Rehabilitation Center ( Site 1502)
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 197758
        • National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1504)
      • Saint Petersburg, Sankt-Peterburg, Russia, 198255
        • City Clinical Oncology Center ( Site 1505)
    • Tatarstan, Respublika
      • Kazan', Tatarstan, Respublika, Russia, 420029
        • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1509)
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6045
        • Cancer Care Langenhoven Drive Oncology Centre ( Site 1701)
    • Gauteng
      • Cape Town, Gauteng, South Africa, 7925
        • Groote Schuur Hospital ( Site 1704)
      • Johannesburg, Gauteng, South Africa, 2193
        • Wits Clinical Research ( Site 1702)
      • Pretoria, Gauteng, South Africa, 0002
        • Department of Medical Oncology ( Site 1703)
      • Pretoria, Gauteng, South Africa, 0031
        • Curo Oncology ( Site 1710)
      • Pretoria, Gauteng, South Africa, 0081
        • Wilgers Oncology Centre ( Site 1705)
      • Pretoria, Gauteng, South Africa, 0181
        • Little Company of Mary Hospital ( Site 1700)
      • Sandton, Gauteng, South Africa, 2196
        • Sandton Oncology Medical Group PTY LTD ( Site 1712)
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4091
        • The Oncology Centre ( Site 1709)
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7700
        • Cancercare ( Site 1706)
      • George, Western Cape, South Africa, 6530
        • Outeniqua Cancercare Oncology Unit ( Site 1708)
      • Kraaifontein, Western Cape, South Africa, 7570
        • Cape Town Oncology Trials Pty Ltd ( Site 1707)
  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital ( Site 2403)
      • Seoul, South Korea, 03722
        • Severance Hospital Yonsei University Health System ( Site 2400)
      • Seoul, South Korea, 05505
        • Asan Medical Center ( Site 2402)
      • Seoul, South Korea, 06351
        • Samsung Medical Center ( Site 2401)
    • Kyonggi-do
      • Seongnam-si, Kyonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital ( Site 2404)
  • Spain
      • Cáceres, Spain, 10003
        • Hospital Provincial San Pedro de Alcantara ( Site 1607)
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Augusti ( Site 1609)
      • Madrid, Spain, 28027
        • Clinica Universitaria de Navarra ( Site 1600)
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio ( Site 1604)
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08909
        • Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1603)
      • Manresa, Barcelona, Spain, 08243
        • Xarxa Assistencial Universitaria Manresa ( Site 1605)
      • Terrassa, Barcelona, Spain, 08227
        • Hospital de Terrassa ( Site 1606)
    • Gipuzkoa
      • Donostia / San Sebastian, Gipuzkoa, Spain, 20014
        • Hospital Universitario de Donostia ( Site 1602)
    • La Coruna
      • A Coruña, La Coruna, Spain, 15006
        • Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1608)
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46009
        • Instituto Valenciano de Oncologia ( Site 1601)
      • Valencia, Valenciana, Comunitat, Spain, 46014
        • Hospital General Universitario de Valencia ( Site 1610)
  • Taiwan
      • Changhua, Taiwan, 50006
        • Changhua Christian Hospital ( Site 2507)
      • Taichung, Taiwan, 40447
        • China Medical University Hospital ( Site 2506)
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital ( Site 2510)
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital ( Site 2508)
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital ( Site 2502)
      • Taipei, Taiwan, 10449
        • MacKay Memorial Hospital ( Site 2500)
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital ( Site 2503)
      • Taoyuan, Taiwan, 333
        • Linkou Chang Gung Memorial Hospital ( Site 2501)
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06050
        • Etlik Zubeyde Hanim Kadin Hastaliklari Egitim ve Arastirma Hastanesi ( Site 1903)
      • Ankara, Turkey (Türkiye), 06590
        • Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 1905)
      • Antalya, Turkey (Türkiye), 07070
        • Akdeniz Universitesi Tıp Fakultesi ( Site 1901)
      • Bursa, Turkey (Türkiye), 16059
        • Uludag Universitesi Tip Fakultesi ( Site 1904)
      • Istanbul, Turkey (Türkiye), 34093
        • Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1900)
      • Istanbul, Turkey (Türkiye), 34147
        • Bakirkoy Sadi Konuk Egitim ve Arastirma Hastanesi ( Site 1907)
      • Istanbul, Turkey (Türkiye), 34214
        • Medipol Universite Hastanesi ( Site 1909)
      • Sakarya, Turkey (Türkiye), 54290
        • Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 1906)
    • Istanbul
      • Küçükçekmece, Istanbul, Turkey (Türkiye), 34303
        • Istanbul Acibadem University Atakent Hospital ( Site 1902)
  • Ukraine
      • Kyiv, Ukraine, 03115
        • Kyiv City Clinical Oncological Center ( Site 2140)
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018
        • MI Precarpathian Clinical Oncology Center ( Site 2181)
    • Kharkivs’ka Oblast’
      • Kharkiv, Kharkivs’ka Oblast’, Ukraine, 61024
        • Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2180)
    • Khmelnytskyi Oblast
      • Khmelnytskyi, Khmelnytskyi Oblast, Ukraine, 29009
        • Municipal non-profit Enterprise Khmelnytskyi Regional Antitu-Gynecological Oncology department, Poli
    • Lviv Oblast
      • Lviv, Lviv Oblast, Ukraine, 79031
        • Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2170)
    • Odesa Oblast
      • Odesa, Odesa Oblast, Ukraine, 65055
        • MI Odessa Regional Oncological Centre ( Site 2121)
    • Sumska Oblast
      • Sumy, Sumska Oblast, Ukraine, 40022
        • RMI - Sumy Regional Clinical Oncology Dispensary ( Site 2191)
    • Zakarpattia Oblast
      • Uzhhorod, Zakarpattia Oblast, Ukraine, 88000
        • Central City Clinical Hospital ( Site 2150)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham (UAB) ( Site 0036)
    • Arizona
      • Tucson, Arizona, United States, 85719
        • University of Arizona Cancer Center ( Site 0074)
    • California
      • Burbank, California, United States, 91505
        • Disney Family Cancer Center ( Site 0042)
      • Oakland, California, United States, 94611
        • Kaiser Permanente Oncology Clinical Trial -Oakland ( Site 0077)
      • Roseville, California, United States, 95661
        • Kaiser Permanente Oncology Clinical Trials-Roseville ( Site 0084)
      • Sacramento, California, United States, 95814
        • Kaiser Permanente Oncology Clinical Trials-Sacramento ( Site 0083)
      • San Francisco, California, United States, 94115
        • Kaiser Permanente Oncology Clinical Trial - San Francisco ( Site 0078)
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Oncology Clinical Trial - Santa Clara ( Site 0079)
      • Vallejo, California, United States, 94589
        • Kaiser Permanente N. CA Regional Oncology Clinical Trials ( Site 0008)
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente Oncology Clinical Trial - Walnut Creek ( Site 0080)
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Smilow Cancer Center at Yale-New Haven ( Site 0057)
    • Florida
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital ( Site 0023)
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory School of Medicine ( Site 0053)
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center ( Site 0029)
      • Savannah, Georgia, United States, 31404
        • Memorial Health University Medical Center ( Site 0011)
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center ( Site 0019)
      • Chicago, Illinois, United States, 60637
        • University of Chicago ( Site 0049)
      • Hinsdale, Illinois, United States, 60521
        • Dr. Sudarshan K. Sharma, LTD ( Site 0061)
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Saint Vincent Hospital and Health Center ( Site 0012)
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital and Clinics ( Site 0005)
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky ( Site 0045)
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Weinberg Cancer Institute at Franklin Square ( Site 0035)
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Saint Dominic - Jackson Memorial Hospital ( Site 0072)
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University - School of Medicine ( Site 0062)
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital ( Site 0063)
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center ( Site 0024)
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • MD Anderson Cancer Center at Cooper ( Site 0067)
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Medical Center ( Site 0037)
    • New York
      • Lake Success, New York, United States, 11042
        • Northwell Health- Monter Cancer Center ( Site 0075)
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Sanford Roger Maris Cancer Center ( Site 0082)
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Miami Valley Hospital [Dayton, OH] ( Site 0073)
      • Cincinnati, Ohio, United States, 45242
        • Oncology/Hematology Care Clinical Trials, LLC ( Site 8001)
      • Columbus, Ohio, United States, 43214
        • The Bing Cancer Center ( Site 0044)
      • Hilliard, Ohio, United States, 43026
        • OSU Wexner Medical Center ( Site 0076)
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital [Providence, RI] ( Site 0039)
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Gynecology Oncology ( Site 0004)
    • Texas
      • Bedford, Texas, United States, 76022
        • Texas Oncology, P.A. - Bedford ( Site 8005)
      • Dallas, Texas, United States, 75231
        • Texas Oncology-Dallas Presbyterian Hospital ( Site 8004)
      • Dallas, Texas, United States, 75235
        • Parkland Hospital ( Site 0081)
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center ( Site 0046)
      • Tyler, Texas, United States, 75702
        • Texas Oncology, P.A. Texas Oncology-Tyler ( Site 8006)
    • Virginia
      • Gainesville, Virginia, United States, 20155
        • Virginia Cancer Specialists, PC ( Site 8003)
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • MEDICAL COLLEGE OF WISCONSIN ( Site 0064)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Drug: Docetaxel
IV infusion
Drug: Paclitaxel
IV infusion
Other Names:
  • TAXOL®
Drug: Carboplatin
IV infusion
Other Names:
  • PARAPLATIN®
Drug: Olaparib
Oral tablet
Other Names:
  • MK-7339
  • LYNPARZA®
Biological: Bevacizumab
IV infusion
Other Names:
  • AVASTIN®
Experimental: 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.
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Drug: Docetaxel
IV infusion
Drug: Paclitaxel
IV infusion
Other Names:
  • TAXOL®
Drug: Carboplatin
IV infusion
Other Names:
  • PARAPLATIN®
Biological: Bevacizumab
IV infusion
Other Names:
  • AVASTIN®
Drug: Placebo for olaparib
Oral tablet
Active Comparator: 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.
Drug: Docetaxel
IV infusion
Drug: Paclitaxel
IV infusion
Other Names:
  • TAXOL®
Drug: Carboplatin
IV infusion
Other Names:
  • PARAPLATIN®
Biological: Bevacizumab
IV infusion
Other Names:
  • AVASTIN®
Drug: Placebo for olaparib
Oral tablet
Drug: Placebo for pembrolizumab
IV infusion
Other Names:
  • normal saline or dextrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Up to approximately 67 months
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
Time Frame: Up to approximately 67 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) in Participants With PD-L1 Positive Tumors (CPS ≥ 10)
Time Frame: Up to approximately 67 months
OS is defined as the time from the date of randomization to death due to any cause. The OS is reported for all participants with PD-L1 positive tumors (CPS≥10). The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Up to approximately 67 months
OS in All Participants
Time Frame: Up to approximately 67 months
OS is defined as the time from the date of randomization to death due to any cause. The OS 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 Blinded Independent Central Review (BICR) in Participants With PD-L1 Positive Tumors (CPS≥10)
Time Frame: Up to approximately 66 months
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review 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 blinded independent central review will be reported for participants with PD-L1 positive (CPS≥10) tumors (CPS≥10). PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Up to approximately 66 months
PFS Per RECIST 1.1 as Assessed by BICR in All Participants
Time Frame: Up to approximately 66 months
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review 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 blinded independent central review will be reported for all participants. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.
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)
Time Frame: Up to approximately 67 months
PFS2 is defined as the time from randomization until PD after second-line treatment 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 PFS2 per RECIST 1.1 as assessed by the Investigator is reported for participants with PD-L1 positive tumors (CPS≥10). PFS2 was calculated using the product-limit (Kaplan-Meier) method for censored data.
Up to approximately 67 months
PFS2 Following Discontinuation of Study Treatment as Assessed by the Investigator in All Participants
Time Frame: Up to approximately 67 months
PFS2 is defined as the time from randomization until PD after second-line treatment 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 PFS2 per RECIST 1.1 as assessed by the Investigator is reported for all participants. PFS2 was calculated using the product-limit (Kaplan-Meier) method for censored data.
Up to approximately 67 months
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) (GHS/QoL) Combined Score
Time Frame: Baseline and week 45
The EORTC-QLQ-C30 is a 30-item questionnaire to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor; 7=Excellent). Using linear transformation, raw scores were standardized so scores ranged from 0 to 100; higher score = better outcome. Change from baseline to Week 45 in EORTC QLQ-C30 Items 29 and 30 combined scores was calculated based on a constrained longitudinal data analysis (cLDA) with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery [planned interval vs R0 following primary vs R1 following primary], and bevacizumab use [Yes vs No], and PD-L1 CPS [<10 vs ≥10]).
Baseline and week 45
Mean Change From Baseline in Abdominal and Gastrointestinal (Abdominal/GI) Symptoms Score Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale
Time Frame: Baseline and week 45
Participant responses to 6 questions from the EORTC QoL Questionnaire-Ovarian Cancer (QLQ-OV28) abdominal/GI symptom scale about abdominal pain, bloated feeling in abdomen/stomach, changes in clothing fit, changes in bowel habit, flatulence, and stomach fullness when eating (questions 31-36) were scored on a 4-point scale (1=Not at all; 4=Very much); lower score = better abdominal/GI symptoms. Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100; a lower score indicating a better overall outcome. Change from baseline to Week 45 in EORTC QLQ-OV28 Items 31-36 combined scores was calculated based on a constrained longitudinal data analysis (cLDA) model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery [planned interval vs R0 following primary vs R1 following primary], and bevacizumab use [Yes vs No], and PD-L1 CPS [<10 vs ≥10]).
Baseline and week 45
Time to Deterioration (TTD) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
Time Frame: Up to approximately 31 months
The EORTC-QLQ-C30 is a 30-item questionnaire to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor; 7=Excellent). Using linear transformation, raw scores were standardized so scores ranged from 0 to 100; higher score = better outcome. TTD is defined as the time from the first EORTC QLQ-C30 Items 29 and 30 combined scores to deterioration (defined as ≥10-point decrease in GHS/QoL score from baseline with confirmation under right-censoring rule [the last observation]) or death, whichever occurs first. TTD was calculated using the product-limit (Kaplan-Meier) method for censored data.
Up to approximately 31 months
Time to Deterioration (TTD) of Abdominal/GI Symptoms Using EORTC QLQ-OV28
Time Frame: Up to approximately 31 months
Participant responses to 6 questions from the EORTC QoL Questionnaire-Ovarian Cancer (QLQ-OV28) abdominal/GI symptom scale about abdominal pain, bloated feeling in abdomen/stomach, changes in clothing fit, changes in bowel habit, flatulence, and stomach fullness when eating (questions 31-36) were scored on a 4-point scale (1=Not at all; 4=Very much); lower score = better abdominal/GI symptoms. Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100; a lower score indicating a better overall outcome. TTD is defined as the time from the first EORTC QLQ-OV28 questions 31-36 combined scores to deterioration (defined as ≥10-point decrease in abdominal/GI symptoms score from baseline with confirmation under right-censoring rule [the last observation]) or death, whichever occurs first. TTD was calculated using the product-limit (Kaplan-Meier) method for censored data.
Up to approximately 31 months
Time to First Subsequent Anti-cancer Treatment (TFST) in All Participants
Time Frame: Up to approximately 67 months
TFST is defined as the time from randomization to initiation of first subsequent anti-cancer treatment or death due to any cause, whichever occurs first. The TFST was determined from the product-limit (Kaplan-Meier) method for censored data.
Up to approximately 67 months
Time to Second Subsequent Anti-cancer Treatment (TSST) in All Participants
Time Frame: Up to approximately 67 months
TSST is defined as the time from randomization to initiation of second subsequent anti-cancer treatment or death due to any cause, whichever occurs first. The TSST was determined from the product-limit (Kaplan-Meier) method for censored data.
Up to approximately 67 months
Time to Discontinuation of Study Treatment or Death (TDT) in All Participants
Time Frame: Up to approximately 67 months
TDT is defined as the time from the date of randomization to discontinuation of study treatment or death due to any cause, whichever occurs first. The TDT was determined from the product-limit (Kaplan-Meier) method for censored data.
Up to approximately 67 months
Pathological Complete Response (pCR) Rate in All Participants
Time Frame: Up to approximately 26 months
pCR is defined as the disappearance of all known disease noted prior to surgery; all surgical specimens collected during the interval debulking surgery are microscopically negative for malignancy. The percentage of participants who experience pCR was determined based on Miettinen & Nurminen method stratified by Bevacizumab use (yes versus no) and PD-L1 status (CPS <10 versus CPS>=10).
Up to approximately 26 months
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 73 months (anticipated)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Up to approximately 73 months (anticipated)
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 6 years (anticipated)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
Up to approximately 6 years (anticipated)
Time to First Subsequent Anti-cancer Treatment (TFST) in Participants With PD-L1 Positive Tumors (CPS≥10)
Time Frame: Up to approximately 67 months
TFST is defined as the time from randomization to initiation of first subsequent anti-cancer treatment or death due to any cause, whichever occurs first. The TFST was determined from the product-limit (Kaplan-Meier) method for censored data.
Up to approximately 67 months
Time to Second Subsequent Anti-cancer Treatment (TSST) in Participants With PD-L1 Positive Tumors (CPS≥10)
Time Frame: Up to approximately 67 months
TSST is defined as the time from randomization to initiation of second subsequent anti-cancer treatment or death due to any cause, whichever occurs first. The TSST was determined from the product-limit (Kaplan-Meier) method for censored data.
Up to approximately 67 months
Time to Discontinuation of Study Treatment or Death (TDT) in Participants With PD-L1 Positive Tumors (CPS≥10)
Time Frame: Up to approximately 67 months
TDT is defined as the time from the date of randomization to discontinuation of study treatment or death due to any cause, whichever occurs first. The TDT was determined from the product-limit (Kaplan-Meier) method for censored data.
Up to approximately 67 months
Pathological Complete Response (pCR) Rate in Participants With PD-L1 Positive Tumors (CPS≥10)
Time Frame: Up to approximately 21 months
pCR is defined as the disappearance of all known disease noted prior to surgery; all surgical specimens collected during the interval debulking surgery are microscopically negative for malignancy. The percentage of participants who experience pCR was determined based on Miettinen & Nurminen method stratified by Bevacizumab use (yes versus no).
Up to approximately 21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Gynecologic Oncology Group
European Network of Gynaecological Oncological Trial Groups (ENGOT)

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2018

Primary Completion (Actual)

August 26, 2024

Study Completion (Actual)

April 15, 2026

Study Registration Dates

First Submitted

November 12, 2018

First Submitted That Met QC Criteria

November 12, 2018

First Posted (Actual)

November 14, 2018

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7339-001
  • ENGOT-ov43 (Other Identifier: European Network of Gynaecological Oncological Trial Groups (ENGOT))
  • MK-7339-001 (Other Identifier: MSD)
  • KEYLYNK-001 (Other Identifier: MSD)
  • 194619 (Registry Identifier: Japic-CTI)
  • GOG-3036 (Other Identifier: Gynecologic Oncology Group (GOG))
  • 2018-001973-25 (EudraCT Number)
  • 2022-502124-52-00 (Registry Identifier: EU CT)
  • U1111-1283-3793 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peritoneal Neoplasms

Clinical Trials on Pembrolizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe