Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65).

A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96/ENGOT-ov65)

The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score [CPS] ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants.

Study Overview

• Status: Active, not recruiting
• Conditions: Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial; Ovarian Cancer
• Intervention / Treatment: Drug: Bevacizumab; Biological: Pembrolizumab; Drug: Docetaxel; Drug: Paclitaxel; Other: Placebo for pembrolizumab

• Study Type: Interventional
• Enrollment (Actual): 643
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital-Department of Gynaecological Oncology ( Site 0201)
  • Queensland
    • Brisbane, Queensland, Australia, 4120
      • Gallipoli Medical Research Foundation-GMRF CTU ( Site 0202)
  • Victoria
    • Melbourne, Victoria, Australia, 3002
      • Epworth Freemasons ( Site 0204)
  • Western Australia
    • Subiaco, Western Australia, Australia, 6008
      • St. John of God Subiaco Hospital ( Site 0203)
• Belgium
  • Bruxelles-Capitale, Region de
    • Brussels, Bruxelles-Capitale, Region de, Belgium, 1000
      • Institut Jules Bordet-Medicine Oncology ( Site 0302)
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent-Medical oncology ( Site 0301)
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • UZ Leuven ( Site 0303)
  • West-Vlaanderen
    • Kortrijk, West-Vlaanderen, Belgium, 8500
      • AZ Groeninge Campus Kennedylaan-Oncology ( Site 0305)
• Brazil
  • Rio de Janeiro, Brazil, 20220-410
    • Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0402)
  • Goiás
    • Goiânia, Goiás, Brazil, 74605-070
      • Hospital Araújo Jorge ( Site 0401)
  • Rio Grande do Norte
    • Natal, Rio Grande do Norte, Brazil, 59075-740
      • Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0404)
  • Santa Catarina
    • Lages, Santa Catarina, Brazil, 88501001
      • ANIMI - Unidade de Tratamento Oncologico ( Site 0408)
  • São Paulo
    • São Paulo, São Paulo, Brazil, 01323-001
      • BP - A Beneficencia Portuguesa de São Paulo ( Site 0403)
    • São Paulo, São Paulo, Brazil, 04014-002
      • Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0405)
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Center ( Site 0511)
  • British Columbia
    • Abbotsford, British Columbia, Canada, V2S 0C2
      • BC Cancer Abbotsford ( Site 0512)
    • Victoria, British Columbia, Canada, V8R 6V5
      • BC Cancer Victoria ( Site 0513)
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston Health Sciences Centre-Kingston General Hospital Si-Oncology and/or Hematology - Gynecolog
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0508)
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0501)
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital ( Site 0505)
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre ( Site 0502)
    • Québec, Quebec, Canada, G1J 1Z4
      • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Center ( Site 0510)
• Chile
  • Los Lagos Region
    • Port Montt, Los Lagos Region, Chile, 5500243
      • Clínica Puerto Montt ( Site 0601)
  • Region M. de Santiago
    • Santiago, Region M. de Santiago, Chile, 7510032
      • Oncovida ( Site 0603)
    • Santiago, Region M. de Santiago, Chile, 7630370
      • Instituto de Radiomedicina-hemato-oncologia ( Site 0604)
    • Santiago, Region M. de Santiago, Chile, 8241479
      • Clínica Vespucio-Hemato - Ocology ( Site 0607)
    • Santiago, Region M. de Santiago, Chile, 8330032
      • Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0609)
    • Santiago, Region M. de Santiago, Chile, 8420383
      • Bradfordhill ( Site 0605)
  • Región de la Araucanía
    • Temuco, Región de la Araucanía, Chile, 4780000
      • James Lind Centro de Investigación del Cáncer ( Site 0602)
    • Temuco, Región de la Araucanía, Chile, 4810148
      • CIDO SpA-Oncology ( Site 0608)
• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 0709)
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer hospital ( Site 0711)
    • Beijing, Beijing Municipality, China, 100730
      • Beijing Peking Union Medical College Hospital-Gynecological center of tumor ( Site 0702)
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Provincial Cancer Hospital ( Site 0713)
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • Lanzhou university second hospital ( Site 0734)
  • Guangdong
    • Guangzhou, Guangdong, China, 510280
      • Zhujiang Hospital ( Site 0739)
    • Zhanjiang, Guangdong, China, 524004
      • Affiliated Hospital of Guangdong Medical University ( Site 0743)
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Guangxi Medical University Affiliated Tumor Hospital ( Site 0717)
  • Hainan
    • Haikou, Hainan, China, 570311
      • Hainan General Hospital ( Site 0736)
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital ( Site 0718)
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Union Hospital-Medical Oncology ( Site 0735)
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 0708)
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University-Gynecology ( Site 0705)
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital ( Site 0704)
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (
    • Nanjing, Jiangsu, China
      • Zhongda Hospital Southeast University ( Site 0723)
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Jiangxi Maternal and Child Health Hospital-Oncology Department ( Site 0716)
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University ( Site 0710)
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital-Oncology Department ( Site 0733)
    • Linyi, Shandong, China, 276001
      • LinYi Cancer Hospital ( Site 0731)
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200011
      • Obstetrics & Gynecology Hospital of Fudan University ( Site 0715)
    • Shanghai, Shanghai Municipality, China, 200032
      • Fudan University Shanghai Cancer Center-Gynecologic Oncology Department ( Site 0701)
    • Shanghai, Shanghai Municipality, China, 201204
      • Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 0744)
  • Sichuan
    • Chengdu, Sichuan, China, 610066
      • West China Second University Hospital Sichuan University ( Site 0740)
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300052
      • Tianjin Central Hosptial of Gynecology Obstetrics ( Site 0737)
    • Tianjin, Tianjin Municipality, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital ( Site 0720)
  • Yunnan
    • Kunming, Yunnan, China, 650106
      • Yunnan Province Cancer Hospital-Gynecology Department ( Site 0714)
  • Zhejiang
    • Hangzhou, Zhejiang, China, 3100000
      • The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 0741)
    • Wenzhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical University-Gynecology ( Site 0706)
• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 050030
      • Fundación Colombiana de Cancerología Clínica Vida ( Site 0808)
  • Atlántico
    • Barranquilla, Atlántico, Colombia, 080020
      • Clinica de la Costa LTDA-Clinical Research Oncology & Hematology -Pediatric ( Site 0809)
  • Bogota D.C.
    • Bogotá, Bogota D.C., Colombia, 111221
      • Clínica Universitaria Colombia ( Site 0806)
  • Risaralda Department
    • Pereira, Risaralda Department, Colombia, 660001
      • Oncologos del Occidente ( Site 0807)
  • Valle del Cauca Department
    • Cali, Valle del Cauca Department, Colombia, 76001
      • Hemato Oncologos SA ( Site 0801)
• Denmark
  • North Denmark
    • Aalborg, North Denmark, Denmark, 9000
      • Aalborg Universitetshospital, Syd ( Site 0901)
• Finland
  • Southwest Finland
    • Turku, Southwest Finland, Finland, 20521
      • Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001)
• France
  • Brittany Region
    • Brest, Brittany Region, France, 29200
      • Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologi
  • Calvados
    • Caen, Calvados, France, 14076
      • Centre François Baclesse-Recherche clinique ( Site 2904)
  • Haute-Vienne
    • Limoges, Haute-Vienne, France, 87042
      • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-oncologie ( Site 2907)
  • Hauts-de-Seine
    • Saint-Cloud, Hauts-de-Seine, France, 92210
      • Institut Curie - site Saint-Cloud ( Site 2909)
  • Ille-et-Vilaine
    • Rennes, Ille-et-Vilaine, France, 35042
      • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 2901)
  • Languedoc-Roussillon
    • Montpellier, Languedoc-Roussillon, France, 34070
      • Centre de Cancérologie du Grand Montpellier ( Site 2908)
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44277
      • Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 2905)
• Germany
  • Berlin, Germany, 13353
    • Charité Campus Virchow-Klinikum ( Site 1201)
  • Hamburg, Germany, 22307
    • Asklepios Kliniken Hamburg-Asklepios Klinik Barmbek ( Site 1214)
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1205)
  • North Rhine-Westphalia
    • Bonn, North Rhine-Westphalia, Germany, 53127
      • Universitätsklinikum Bonn-Gynaecological oncology ( Site 1203)
    • Düsseldorf, North Rhine-Westphalia, Germany, 40225
      • Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204)
    • Krefeld, North Rhine-Westphalia, Germany, 47805
      • Zentrum fuer ambulante gynaekologische Onkologie (ZAGO) ( Site 1207)
  • Saarland
    • Saarbrücken, Saarland, Germany, 66113
      • CaritasKlinikum Saarbrücken St. Theresia ( Site 1211)
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur
    • Leipzig, Saxony, Germany, 04103
      • Universitätsklinikum Leipzig-Department of Gynecology and Obstetrics ( Site 1213)
• Ireland
  • Dublin, Ireland, D08 E9P6
    • St. James's Hospital-Cancer clinical trials office ( Site 2821)
• Israel
  • Afula, Israel, 1834111
    • Emek Medical Center-Gyn-Onc ( Site 1406)
  • Beersheba, Israel, 8410101
    • Soroka Medical Center ( Site 1404)
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus-Gyneco-oncology unit ( Site 1402)
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center ( Site 1405)
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center ( Site 1401)
  • Ramat Gan, Israel, 5265601
    • Sheba Medical Center ( Site 1407)
  • Tel Aviv, Israel, 6423906
    • Sourasky Medical Center ( Site 1403)
• Italy
  • Brescia, Italy, 25123
    • Azienda Ospedaliera Spedali Civili di Brescia ( Site 1504)
  • Milan, Italy, 20141
    • Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 1502)
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • IRCCS - AOU di Bologna-SSD Oncologia medica Addarii ( Site 1501)
  • Lombardy
    • Milan, Lombardy, Italy, 20133
      • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1503)
    • Monza, Lombardy, Italy, 20900
      • Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1508)
  • Milano
    • Milan, Milano, Italy, 20162
      • ASST Grande Ospedale Metropolitano Niguarda ( Site 1505)
  • Piedmont
    • Turin, Piedmont, Italy, 10128
      • Ospedale Mauriziano-Ginecologia e Ostetricia ( Site 1507)
• Japan
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute ( Site 1602)
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Aichi Cancer Center Hospital ( Site 1610)
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East ( Site 1609)
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • National Hospital Organization Shikoku Cancer Center ( Site 1603)
    • Tōon, Ehime, Japan, 791-0295
      • Ehime University Hospital ( Site 1606)
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Kurume University Hospital ( Site 1607)
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital ( Site 1604)
  • Iwate
    • Shiwa-gun Yahaba-cho, Iwate, Japan, 028-3695
      • Iwate Medical University Hospital ( Site 1613)
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 211-8533
      • Nippon Medical School Musashi Kosugi Hospital ( Site 1614)
  • Saitama
    • Hidaka-shi, Saitama, Japan, 350-1200
      • Saitama Medical University International Medical Center ( Site 1601)
  • Shizuoka
    • Nakatogari, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center ( Site 1611)
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital ( Site 1612)
    • Koto, Tokyo, Japan, 135-8550
      • Japanese Foundation for Cancer Research ( Site 1605)
• Mexico
  • Oaxaca City, Mexico, 68020
    • Centro de Investigacion Clinica de Oaxaca ( Site 1705)
  • Baja California Sur
    • La Paz, Baja California Sur, Mexico, 23040
      • Investigación Oncofarmacéutica-Investigación clínica ( Site 1706)
  • Mexico City
    • Mexico City, Mexico City, Mexico, 04700
      • COI Centro Oncologico Internacional S.A.P.I. de C.V.-Investigation Unit COI ( Site 1703)
    • Mexico City, Mexico City, Mexico, 14070
      • INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1701)
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64710
      • iCan Oncology Center Centro Medico AVE ( Site 1704)
• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1804)
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboudumc ( Site 1802)
  • South Holland
    • Leiden, South Holland, Netherlands, 2333 ZA
      • Leids Universitair Medisch Centrum-Medical Oncology ( Site 1801)
    • Rotterdam, South Holland, Netherlands, 3015 GD
      • Erasmus Medisch Centrum-Medical Oncology ( Site 1803)
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital ( Site 1901)
• Norway
  • Troms
    • Tromsø, Troms, Norway, 9038
      • Universitetssykehuset Nord-Norge HF-Kreftavdelingen ( Site 2001)
• Poland
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 61-848
      • Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Me-Oddzial Ginekologii Onkologicznej ( Sit
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 00-315
      • Szpital Kliniczny im. Księżnej Anny Mazowieckiej ( Site 2103)
    • Warsaw, Masovian Voivodeship, Poland, 02-781
      • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Gynecological Oncology Department ( Sit
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-027
      • Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2106)
    • Bialystok, Podlaskie Voivodeship, Poland, 15-276
      • Uniwersytecki Szpital Kliniczny w Bialymstoku-Uniwersyteckie Centrum Onkologii ( Site 2104)
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-214
      • Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi
  • Silesian Voivodeship
    • Gliwice, Silesian Voivodeship, Poland, 44-101
      • Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 21
  • Świętokrzyskie Voivodeship
    • Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
      • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2107)
• Russia
  • Chelyabinsk Oblast
    • Chelyabinsk, Chelyabinsk Oblast, Russia, 454087
      • Chelyabinsk Regional Clinical Oncology Dispensary-Chelyabinsk Regional Clinical Oncology Dispensary
  • Mordoviya, Respublika
    • Saransk, Mordoviya, Respublika, Russia, 430005
      • Ogarev Mordovia State University ( Site 2209)
  • Moscow
    • Moscow, Moscow, Russia, 115478
      • Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF-Chemotherapy #2 ( Site 2211)
  • Moscow Oblast
    • Krasnogorsk D-t, Moscow Oblast, Russia, 143423
      • Moscow City Oncology Hospital #62 ( Site 2214)
  • Sverdlovsk Oblast
    • Yekaterinburg, Sverdlovsk Oblast, Russia, 620905
      • SVERDLOVSK REGIONAL ONCOLOGY DISPENSARY-Oncogynecology Department ( Site 2216)
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital ( Site 2302)
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 2303)
  • Seoul, South Korea, 05505
    • Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 2304)
  • Seoul, South Korea, 06273
    • Gangnam Severance Hospital ( Site 2301)
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01250
    • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2704)
  • Ankara, Turkey (Türkiye), 06100
    • Ankara University Hospital Cebeci ( Site 2701)
  • Ankara, Turkey (Türkiye), 34180
    • Baskent Universitesi Ankara Hastanesi ( Site 2707)
  • Istanbul, Turkey (Türkiye), 34093
    • Bezmialem Vakf Üniversitesi-Oncology ( Site 2705)
  • Istanbul, Turkey (Türkiye), 34440
    • T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma
  • Adana
    • Sarçam, Adana, Turkey (Türkiye), 01250
      • cukurova universty ( Site 2706)
  • Istanbul
    • Fatih, Istanbul, Turkey (Türkiye), 34098
      • Istanbul Universitesi Cerrahpasa ( Site 2709)
  • İzmir
    • Bornova, İzmir, Turkey (Türkiye), 35100
      • Ege University Medicine of Faculty ( Site 2702)
• United Kingdom
  • Cardiff, United Kingdom, CF14 2TL
    • Velindre Cancer Centre ( Site 2805)
  • Brighton And Hove
    • East Sussex, Brighton And Hove, United Kingdom, BN2 5BE
      • Brighton and Sussex University Hospitals NHS Trust ( Site 2803)
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
      • Addenbrooke's Hospital ( Site 2808)
  • Cornwall
    • Truro, Cornwall, United Kingdom, TR1 3LJ
      • The Royal Cornwall Hospital ( Site 2804)
  • Cumbria
    • Kendal, Cumbria, United Kingdom, LA9 7RG
      • Westmorland General Hospital ( Site 2815)
  • Dundee City
    • Dundee, Dundee City, United Kingdom, DD1 9SY
      • Ninewells Hospital and Medical School ( Site 2826)
  • England
    • Leicester, England, United Kingdom
      • Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 2812)
  • London, City of
    • London, London, City of, United Kingdom, W12 0HS
      • Hammersmith Hospital-Medical Oncology ( Site 2818)
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • HonorHealth ( Site 0041)
  • California
    • Greenbrae, California, United States, 94904
      • Marin Cancer Care ( Site 0055)
    • Monterey, California, United States, 93940
      • Pacific Cancer Care ( Site 0028)
    • Rancho Mirage, California, United States, 92270
      • Eisenhower Medical Center ( Site 0067)
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004)
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 0054
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital ( Site 0018)
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center ( Site 0033)
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005)
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Advocate Medical Group-Oncology ( Site 0049)
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Research Center at Parkview Regional Medical Center ( Site 0027)
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Hospital and Health Care Center, Inc ( Site 0032)
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0040)
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • WK Physicians Network / Hematology Oncology Associates ( Site 0034)
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0015)
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • University of Massachusetts Chan Medical School-Division of Gynecologic Oncology ( Site 0003)
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0007)
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute ( Site 0039)
    • New York, New York, United States, 10032
      • Columbia University Medical Center ( Site 0010)
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Presbyterian Medical Center ( Site 0029)
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Institute ( Site 0038)
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Forsyth Medical Center ( Site 0057)
  • Ohio
    • Canton, Ohio, United States, 44710
      • Aultman Hospital-Oncology Clinical Trials ( Site 0009)
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center-Cancer Care Center ( Site 0047)
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center ( Site 0048)
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0024)
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford Cancer Center ( Site 0064)
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The West Clinic, PLLC dba West Cancer Center ( Site 0058)
  • Texas
    • Dallas, Texas, United States, 75231
      • Texas Oncology - Dallas (Presbyterian) ( Site 0065)
    • The Woodlands, Texas, United States, 77380
      • Texas Oncology - The Woodlands_Lee ( Site 0043)
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Schar Cancer Institute ( Site 0019)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
• Has received 1 or 2 prior lines of systemic therapy for ovarian cancer (OC), including at least 1 prior platinum-based therapy. Participants may have received a prior poly (ADP-ribose) polymerase inhibitor (PARPi), anti-programmed cell death 1 protein (PD-1)/anti-programmed cell death ligand 1 (PD-L1) therapy, bevacizumab, or hormonal therapy; these will not be considered a separate line of therapy. Any chemotherapy regimen change due to toxicity in the absence of disease progression will be considered part of the same line of therapy.
• Has provided documented informed consent for the study.
• Has radiographic evidence of disease progression within 6 months (180 days) after the last dose of platinum-based chemotherapy for OC (i.e., platinum-resistant disease).
• Is a candidate for paclitaxel chemotherapy (and bevacizumab, if using).
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 3 days before randomization.
• For a female participant, she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and uses a contraceptive method that is highly effective (with a failure rate of <1% per year).
• Has radiographically evaluable disease, either measurable or nonmeasurable per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, as assessed by the local site investigator.
• Archival tumor tissue sample or newly obtained core or incisional/excisional biopsy of a tumor lesion not previously irradiated has been provided.
• Have adequate organ function.

Exclusion Criteria:

• Has nonepithelial cancers, borderline tumors, mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma.
• Has primary platinum-refractory disease, defined as disease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of first-line platinum-based therapy.
• Has prior disease progression on weekly paclitaxel alone.
• Has received >2 prior lines of systemic therapy for OC.
• Has received prior systemic anticancer therapy including investigational agents or maintenance therapy (including bevacizumab maintenance therapy), within 4 weeks before randomization.
• Has received prior radiation therapy within 2 weeks of start of study intervention.
• Has not recovered adequately from surgery and/or any complications from the surgery.
• Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor,[GM-CSF] or recombinant erythropoietin) within 4 weeks before randomization.
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
• Has received investigational agent or has used an investigational device within 4 weeks prior to study intervention.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has severe hypersensitivity (≥Grade 3) to pembrolizumab, paclitaxel, or bevacizumab (if using) and/or any of their excipients.
• Has an active autoimmune disease that has required systemic treatment in the past 2 years.
• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
• Has an active infection requiring systemic therapy.
• Has a known history of human immunodeficiency virus (HIV) infection.
• Has a known history of Hepatitis B or known active Hepatitis C virus infection.
• Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study.
• Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
• Participant, in the judgement of the investigator, is unlikely to comply with the study procedures, restrictions, and requirements of the study.
• Has had an allogenic tissue/solid organ transplant.

For bevacizumab treatment

• Has uncontrolled hypertension.
• Has current, clinically relevant bowel obstruction including related to underlying epithelial OC, abdominal fistula or gastrointestinal perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam.
• Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months before randomization.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pembrolizumab + paclitaxel ± bevacizumab; Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event (AE) requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.	Drug: Bevacizumab; IV infusion; Other Names: AVASTIN®, Zirabev; Biological: Pembrolizumab; IV infusion; Other Names: KEYTRUDA®; MK-3475,; Drug: Docetaxel; IV infusion; Other Names: TAXOTERE®; Drug: Paclitaxel; IV infusion; Other Names: TAXOL®
Placebo Comparator: Placebo + paclitaxel ± bevacizumab; Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event (AE) requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.	Drug: Bevacizumab; IV infusion; Other Names: AVASTIN®, Zirabev; Drug: Docetaxel; IV infusion; Other Names: TAXOTERE®; Drug: Paclitaxel; IV infusion; Other Names: TAXOL®; Other: 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 Cell Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS] ≥1)	PFS was 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 was 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. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. Per protocol, PFS per RECIST 1.1 as assessed by the Investigator in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.	Up to ~38 months
PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants	PFS was 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 was 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. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. 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 ~38 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from the date of randomization to death due to any cause. The OS will be reported for all participants.	Up to ~64 months
Change From Baseline in Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.	Baseline and up to ~64 months
Time to Deterioration (TTD) in the GHS/Qol Score (Items 29 and 30) Using the EORTC QLQ-C30	TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Items 29 and 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.	Up to ~64 months
Change From Baseline in the Abdominal and Gastrointestinal (GI) Symptoms Score (Items 31 to 36) Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale	The EORTC QLQ-OV28 is an abdominal and gastrointestinal questionnaire (items 31-36). Participant responses to the question "Did you have abdominal pain ?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in abdominal and gastrointestinal symptoms (EORTC QLQ-LC28 Items 31-36) score will be presented. A lower score indicates a better outcome.	Baseline and up to ~64 months
TTD in the Abdominal and GI Symptoms Score (Items 31 to 36) Using the EORTC QLQ-OV28 Abdominal/GI Symptom Scale	TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C28 Items 31-36) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.	Up to ~64 months
PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1	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. The appearance of one or more 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 (BICR) in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.	Up to ~38 months
PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in All Participants	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. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more 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 (BICR) in all participants is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.	Up to ~38 months
Number of Participants Who Experience an Adverse Event (AE)	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.	Up to ~64 months
Number of Participants Who Discontinue Study Treatment Due to an AE	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.	Up to ~64 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Actual): March 5, 2025
• Study Completion (Estimated): July 16, 2027

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1)
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Genital Diseases, Female; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Carcinoma; Fallopian Tube Diseases; Carcinoma, Ovarian Epithelial; Ovarian Neoplasms; Fallopian Tube Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Pharmaceutical Preparations; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Diterpenes; Crystalloid Solutions; Isotonic Solutions; Solutions; Sugars; Hexoses; Monosaccharides; Docetaxel; Bevacizumab; Paclitaxel; Saline Solution; pembrolizumab; Glucose
• Other Study ID Numbers: 3475-B96; MK-3475-B96 (Other Identifier: MSD); KEYNOTE-B96 (Other Identifier: MSD); ENGOT-ov65 (Other Identifier: European Network of Gynaecological Oncological Trial groups); jRCT2051210184 (Registry Identifier: Japan Registry of Clinical Trials (jRCT)); 2020-005027-37 (EudraCT Number); U1111-1287-5318 (Registry Identifier: UTN); 2023-506177-35-00 (Registry Identifier: EU CT)

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