AzTrials
AzTrials

Ovarian CancerPhase 3NCT05116189

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

A Phase 3 study testing Pembrolizumab, Paclitaxel and Bevacizumab in people with Ovarian Cancer and Carcinoma, Ovarian Epithelial, run by Merck Sharp & Dohme LLC at 187 sites in 25 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Pembrolizumab, Paclitaxel and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
643 participants
Where
187 sitesin 25 countries
Study dates
13 Dec 2021to 16 Jul 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

187 sites in 25 countries.

187 sites in 25 countries

United States31 sites

  • Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0015)

    Baltimore, Maryland, 21202

  • Roswell Park Cancer Institute ( Site 0039)

    Buffalo, New York, 14263

  • Aultman Hospital-Oncology Clinical Trials ( Site 0009)

    Canton, Ohio, 44710

  • Novant Health Presbyterian Medical Center ( Site 0029)

    Charlotte, North Carolina, 28204

  • MetroHealth Medical Center-Cancer Care Center ( Site 0047)

    Cleveland, Ohio, 44109

  • Texas Oncology - Dallas (Presbyterian) ( Site 0065)

    Dallas, Texas, 75231

  • Duke Cancer Institute ( Site 0038)

    Durham, North Carolina, 27710

  • Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0040)

    Edgewood, Kentucky, 41017

  • Inova Schar Cancer Institute ( Site 0019)

    Fairfax, Virginia, 22031

  • Parkview Research Center at Parkview Regional Medical Center ( Site 0027)

    Fort Wayne, Indiana, 46845

  • University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 0054

    Gainesville, Florida, 32610

  • The West Clinic, PLLC dba West Cancer Center ( Site 0058)

    Germantown, Tennessee, 38138

  • Marin Cancer Care ( Site 0055)

    Greenbrae, California, 94904

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0007)

    Hackensack, New Jersey, 07601

  • St. Vincent Hospital and Health Care Center, Inc ( Site 0032)

    Indianapolis, Indiana, 46260

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005)

    Marietta, Georgia, 30060

  • Pacific Cancer Care ( Site 0028)

    Monterey, California, 93940

  • Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004)

    New Haven, Connecticut, 06511

  • Columbia University Medical Center ( Site 0010)

    New York, New York, 10032

  • Advocate Medical Group-Oncology ( Site 0049)

    Park Ridge, Illinois, 60068

  • HonorHealth ( Site 0041)

    Phoenix, Arizona, 85016

  • University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0024)

    Pittsburgh, Pennsylvania, 15219

  • Providence Portland Medical Center ( Site 0048)

    Portland, Oregon, 97213

  • Eisenhower Medical Center ( Site 0067)

    Rancho Mirage, California, 92270

  • Sarasota Memorial Hospital ( Site 0018)

    Sarasota, Florida, 34239

  • WK Physicians Network / Hematology Oncology Associates ( Site 0034)

    Shreveport, Louisiana, 71103

  • Sanford Cancer Center ( Site 0064)

    Sioux Falls, South Dakota, 57104

  • Moffitt Cancer Center ( Site 0033)

    Tampa, Florida, 33612

  • Texas Oncology - The Woodlands_Lee ( Site 0043)

    The Woodlands, Texas, 77380

  • Novant Health Forsyth Medical Center ( Site 0057)

    Winston-Salem, North Carolina, 27103

  • University of Massachusetts Chan Medical School-Division of Gynecologic Oncology ( Site 0003)

    Worcester, Massachusetts, 01605

Other trials in United States

China29 sites

  • Beijing Cancer hospital ( Site 0711)

    Beijing, Beijing Municipality, 100142

  • Beijing Peking Union Medical College Hospital-Gynecological center of tumor ( Site 0702)

    Beijing, Beijing Municipality, 100730

  • The First Hospital of Jilin University ( Site 0710)

    Changchun, Jilin, 130021

  • Xiangya Hospital Central South University-Gynecology ( Site 0705)

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital ( Site 0704)

    Changsha, Hunan, 410013

  • West China Second University Hospital Sichuan University ( Site 0740)

    Chengdu, Sichuan, 610066

  • Fujian Provincial Cancer Hospital ( Site 0713)

    Fuzhou, Fujian, 350014

  • Zhujiang Hospital ( Site 0739)

    Guangzhou, Guangdong, 510280

  • Hainan General Hospital ( Site 0736)

    Haikou, Hainan, 570311

  • The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 0741)

    Hangzhou, Zhejiang, 3100000

  • Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 0709)

    Hefei, Anhui, 230001

  • Shandong Cancer Hospital-Oncology Department ( Site 0733)

    Jinan, Shandong, 250117

  • Yunnan Province Cancer Hospital-Gynecology Department ( Site 0714)

    Kunming, Yunnan, 650106

  • Lanzhou university second hospital ( Site 0734)

    Lanzhou, Gansu, 730030

  • LinYi Cancer Hospital ( Site 0731)

    Linyi, Shandong, 276001

  • Jiangxi Maternal and Child Health Hospital-Oncology Department ( Site 0716)

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (

    Nanjing, Jiangsu, 210000

  • Zhongda Hospital Southeast University ( Site 0723)

    Nanjing, Jiangsu

  • Guangxi Medical University Affiliated Tumor Hospital ( Site 0717)

    Nanning, Guangxi, 530021

  • Obstetrics & Gynecology Hospital of Fudan University ( Site 0715)

    Shanghai, Shanghai Municipality, 200011

  • Fudan University Shanghai Cancer Center-Gynecologic Oncology Department ( Site 0701)

    Shanghai, Shanghai Municipality, 200032

  • Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 0744)

    Shanghai, Shanghai Municipality, 201204

  • Tianjin Central Hosptial of Gynecology Obstetrics ( Site 0737)

    Tianjin, Tianjin Municipality, 300052

  • Tianjin Medical University Cancer Institute and Hospital ( Site 0720)

    Tianjin, Tianjin Municipality, 300060

  • The First Affiliated Hospital of Wenzhou Medical University-Gynecology ( Site 0706)

    Wenzhou, Zhejiang, 325000

  • Wuhan Union Hospital-Medical Oncology ( Site 0735)

    Wuhan, Hubei, 430022

  • Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 0708)

    Wuhan, Hubei, 430079

  • Affiliated Hospital of Guangdong Medical University ( Site 0743)

    Zhanjiang, Guangdong, 524004

  • Henan Cancer Hospital ( Site 0718)

    Zhengzhou, Henan, 450008

Other trials in China

Japan13 sites

  • National Cancer Center Hospital ( Site 1612)

    Chuo-ku, Tokyo, 104-0045

  • Saitama Medical University International Medical Center ( Site 1601)

    Hidaka-shi, Saitama, 350-1200

  • National Cancer Center Hospital East ( Site 1609)

    Kashiwa, Chiba, 277-8577

  • Nippon Medical School Musashi Kosugi Hospital ( Site 1614)

    Kawasaki, Kanagawa, 211-8533

  • Japanese Foundation for Cancer Research ( Site 1605)

    Koto, Tokyo, 135-8550

  • Kurume University Hospital ( Site 1607)

    Kurume, Fukuoka, 830-0011

  • National Hospital Organization Shikoku Cancer Center ( Site 1603)

    Matsuyama, Ehime, 791-0280

  • Aichi Cancer Center Hospital ( Site 1610)

    Nagoya, Aichi-ken, 464-8681

  • Shizuoka Cancer Center ( Site 1611)

    Nakatogari, Shizuoka, 411-8777

  • Osaka International Cancer Institute ( Site 1602)

    Osaka, 541-8567

  • Hokkaido University Hospital ( Site 1604)

    Sapporo, Hokkaido, 060-8648

  • Iwate Medical University Hospital ( Site 1613)

    Shiwa-gun Yahaba-cho, Iwate, 028-3695

  • Ehime University Hospital ( Site 1606)

    Tōon, Ehime, 791-0295

Other trials in Japan

Canada10 sites

  • BC Cancer Abbotsford ( Site 0512)

    Abbotsford British Columbia, British Columbia, V2S 0C2

  • Tom Baker Cancer Center ( Site 0511)

    Calgary, Alberta, T2N 4N2

  • Kingston Health Sciences Centre-Kingston General Hospital Si-Oncology and/or Hematology - Gynecolog

    Kingston, Ontario, K7L 2V7

  • CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0501)

    Montreal, Quebec, H1T 2M4

  • Jewish General Hospital ( Site 0505)

    Montreal, Quebec, H3T 1E2

  • McGill University Health Centre ( Site 0502)

    Montreal, Quebec, H4A 3J1

  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

    Québec, Quebec, G1J 1Z4

  • Saskatoon Cancer Center ( Site 0510)

    Saskatoon, Saskatchewan, S7N 4H4

  • Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0508)

    Toronto, Ontario, M4N 3M5

  • BC Cancer Victoria ( Site 0513)

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

Germany9 sites

  • Charité Campus Virchow-Klinikum ( Site 1201)

    Berlin, 13353

  • Universitätsklinikum Bonn-Gynaecological oncology ( Site 1203)

    Bonn, North Rhine-Westphalia, 53127

  • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur

    Dresden, Saxony, 01307

  • Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204)

    Düsseldorf, North Rhine-Westphalia, 40225

  • Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1205)

    Erlangen, Bavaria, 91054

  • Asklepios Kliniken Hamburg-Asklepios Klinik Barmbek ( Site 1214)

    Hamburg, 22307

  • Zentrum fuer ambulante gynaekologische Onkologie (ZAGO) ( Site 1207)

    Krefeld, North Rhine-Westphalia, 47805

  • Universitätsklinikum Leipzig-Department of Gynecology and Obstetrics ( Site 1213)

    Leipzig, Saxony, 04103

  • CaritasKlinikum Saarbrücken St. Theresia ( Site 1211)

    Saarbrücken, Saarland, 66113

Other trials in Germany

Chile8 sites

  • Clínica Puerto Montt ( Site 0601)

    Port Montt, Los Lagos Region, 5500243

  • Oncovida ( Site 0603)

    Santiago, Region M. de Santiago, 7510032

  • Instituto de Radiomedicina-hemato-oncologia ( Site 0604)

    Santiago, Region M. de Santiago, 7630370

  • Clínica Vespucio-Hemato - Ocology ( Site 0607)

    Santiago, Region M. de Santiago, 8241479

  • Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0609)

    Santiago, Region M. de Santiago, 8330032

  • Bradfordhill ( Site 0605)

    Santiago, Region M. de Santiago, 8420383

  • James Lind Centro de Investigación del Cáncer ( Site 0602)

    Temuco, Araucania, 4780000

  • CIDO SpA-Oncology ( Site 0608)

    Temuco, Araucania, 4810148

Other trials in Chile

Poland8 sites

  • Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2106)

    Bialystok, Podlaskie Voivodeship, 15-027

  • Uniwersytecki Szpital Kliniczny w Bialymstoku-Uniwersyteckie Centrum Onkologii ( Site 2104)

    Bialystok, Podlaskie Voivodeship, 15-276

  • Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi

    Gdansk, Pomeranian Voivodeship, 80-214

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 21

    Gliwice, Silesian Voivodeship, 44-101

  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2107)

    Kielce, Świętokrzyskie Voivodeship, 25-734

  • Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Me-Oddzial Ginekologii Onkologicznej ( Sit

    Poznan, Greater Poland Voivodeship, 61-848

  • Szpital Kliniczny im. Księżnej Anny Mazowieckiej ( Site 2103)

    Warsaw, Masovian Voivodeship, 00-315

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Gynecological Oncology Department ( Sit

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Turkey (Türkiye)8 sites

  • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2704)

    Adana, 01250

  • Ankara University Hospital Cebeci ( Site 2701)

    Ankara, 06100

  • Baskent Universitesi Ankara Hastanesi ( Site 2707)

    Ankara, 34180

  • Ege University Medicine of Faculty ( Site 2702)

    Bornova, İzmir, 35100

  • Istanbul Universitesi Cerrahpasa ( Site 2709)

    Fatih, Istanbul, 34098

  • Bezmialem Vakf Üniversitesi-Oncology ( Site 2705)

    Istanbul, 34093

  • T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma

    Istanbul, 34440

  • cukurova universty ( Site 2706)

    Sarçam, Adana, 01250

Other trials in Turkey (Türkiye)

United Kingdom8 sites

  • Addenbrooke's Hospital ( Site 2808)

    Cambridge, Cambridgeshire, CB2 2QQ

  • Velindre Cancer Centre ( Site 2805)

    Cardiff, CF14 2TL

  • Ninewells Hospital and Medical School ( Site 2826)

    Dundee, Dundee City, DD1 9SY

  • Brighton and Sussex University Hospitals NHS Trust ( Site 2803)

    East Sussex, Brighton And Hove, BN2 5BE

  • Westmorland General Hospital ( Site 2815)

    Kendal, Cumbria, LA9 7RG

  • Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 2812)

    Leicester, England

  • Hammersmith Hospital-Medical Oncology ( Site 2818)

    London, London, City of, W12 0HS

  • The Royal Cornwall Hospital ( Site 2804)

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

France7 sites

  • Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologi

    Brest, Brittany Region, 29200

  • Centre François Baclesse-Recherche clinique ( Site 2904)

    Caen, Calvados, 14076

  • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-oncologie ( Site 2907)

    Limoges, Haute-Vienne, 87042

  • Centre de Cancérologie du Grand Montpellier ( Site 2908)

    Montpellier, Languedoc-Roussillon, 34070

  • Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 2905)

    Nantes, Loire-Atlantique, 44277

  • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 2901)

    Rennes, Ille-et-Vilaine, 35042

  • Institut Curie - site Saint-Cloud ( Site 2909)

    Saint-Cloud, Hauts-de-Seine, 92210

Other trials in France

Israel7 sites

  • Emek Medical Center-Gyn-Onc ( Site 1406)

    Afula, 1834111

  • Soroka Medical Center ( Site 1404)

    Beersheba, 8410101

  • Rambam Health Care Campus-Gyneco-oncology unit ( Site 1402)

    Haifa, 3109601

  • Shaare Zedek Medical Center ( Site 1405)

    Jerusalem, 9103102

  • Rabin Medical Center ( Site 1401)

    Petah Tikva, 49100

  • Sheba Medical Center ( Site 1407)

    Ramat Gan, 5265601

  • Sourasky Medical Center ( Site 1403)

    Tel Aviv, 6423906

Other trials in Israel

Italy7 sites

  • IRCCS - AOU di Bologna-SSD Oncologia medica Addarii ( Site 1501)

    Bologna, Emilia-Romagna, 40138

  • Azienda Ospedaliera Spedali Civili di Brescia ( Site 1504)

    Brescia, 25123

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1503)

    Milan, Lombardy, 20133

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 1505)

    Milan, Milano, 20162

  • Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 1502)

    Milan, 20141

  • Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1508)

    Monza, Lombardy, 20900

  • Ospedale Mauriziano-Ginecologia e Ostetricia ( Site 1507)

    Turin, Piedmont, 10128

Other trials in Italy

Brazil6 sites

  • Hospital Araújo Jorge ( Site 0401)

    Goiânia, Goiás, 74605-070

  • ANIMI - Unidade de Tratamento Oncologico ( Site 0408)

    Lages, Santa Catarina, 88501001

  • Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0404)

    Natal, Rio Grande do Norte, 59075-740

  • Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0402)

    Rio de Janeiro, 20220-410

  • BP - A Beneficencia Portuguesa de São Paulo ( Site 0403)

    São Paulo, São Paulo, 01323-001

  • Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0405)

    São Paulo, São Paulo, 04014-002

Other trials in Brazil

Colombia5 sites

  • Clinica de la Costa LTDA-Clinical Research Oncology & Hematology -Pediatric ( Site 0809)

    Barranquilla, Atlántico, 080020

  • Clínica Universitaria Colombia ( Site 0806)

    Bogotá, Bogota D.C., 111221

  • Hemato Oncologos SA ( Site 0801)

    Cali, Valle del Cauca Department, 76001

  • Fundación Colombiana de Cancerología Clínica Vida ( Site 0808)

    Medellín, Antioquia, 050030

  • Oncologos del Occidente ( Site 0807)

    Pereira, Risaralda Department, 660001

Other trials in Colombia

Mexico5 sites

  • Investigación Oncofarmacéutica-Investigación clínica ( Site 1706)

    La Paz, Baja California Sur, 23040

  • COI Centro Oncologico Internacional S.A.P.I. de C.V.-Investigation Unit COI ( Site 1703)

    Mexico City, Mexico City, 04700

  • INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1701)

    Mexico City, Mexico City, 14070

  • iCan Oncology Center Centro Medico AVE ( Site 1704)

    Monterrey, Nuevo León, 64710

  • Centro de Investigacion Clinica de Oaxaca ( Site 1705)

    Oaxaca City, 68020

Other trials in Mexico

Russia5 sites

  • Chelyabinsk Regional Clinical Oncology Dispensary-Chelyabinsk Regional Clinical Oncology Dispensary

    Chelyabinsk, Chelyabinsk Oblast, 454087

  • Moscow City Oncology Hospital #62 ( Site 2214)

    Krasnogorsk D-t, Moscow Oblast, 143423

  • Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF-Chemotherapy #2 ( Site 2211)

    Moscow, Moscow, 115478

  • Ogarev Mordovia State University ( Site 2209)

    Saransk, Mordoviya, Respublika, 430005

  • SVERDLOVSK REGIONAL ONCOLOGY DISPENSARY-Oncogynecology Department ( Site 2216)

    Yekaterinburg, Sverdlovsk Oblast, 620905

Other trials in Russia

Australia4 sites

  • Gallipoli Medical Research Foundation-GMRF CTU ( Site 0202)

    Brisbane, Queensland, 4120

  • Epworth Freemasons ( Site 0204)

    Melbourne, Victoria, 3002

  • St. John of God Subiaco Hospital ( Site 0203)

    Subiaco, Western Australia, 6008

  • Westmead Hospital-Department of Gynaecological Oncology ( Site 0201)

    Westmead, New South Wales, 2145

Other trials in Australia

Belgium4 sites

  • Institut Jules Bordet-Medicine Oncology ( Site 0302)

    Brussels, Bruxelles-Capitale, Region de, 1000

  • UZ Gent-Medical oncology ( Site 0301)

    Ghent, Oost-Vlaanderen, 9000

  • AZ Groeninge Campus Kennedylaan-Oncology ( Site 0305)

    Kortrijk, West-Vlaanderen, 8500

  • UZ Leuven ( Site 0303)

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

Netherlands4 sites

  • Leids Universitair Medisch Centrum-Medical Oncology ( Site 1801)

    Leiden, South Holland, 2333 ZA

  • Radboudumc ( Site 1802)

    Nijmegen, Gelderland, 6525 GA

  • Erasmus Medisch Centrum-Medical Oncology ( Site 1803)

    Rotterdam, South Holland, 3015 GD

  • Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1804)

    Utrecht, 3584 CX

Other trials in Netherlands

South Korea4 sites

  • Seoul National University Hospital ( Site 2302)

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 2303)

    Seoul, 03722

  • Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 2304)

    Seoul, 05505

  • Gangnam Severance Hospital ( Site 2301)

    Seoul, 06273

Other trials in South Korea

Denmark1 site

  • Aalborg Universitetshospital, Syd ( Site 0901)

    Aalborg, North Denmark, 9000

Other trials in Denmark

Finland1 site

  • Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001)

    Turku, Southwest Finland, 20521

Other trials in Finland

Ireland1 site

  • St. James's Hospital-Cancer clinical trials office ( Site 2821)

    Dublin, D08 E9P6

Other trials in Ireland

New Zealand1 site

  • Auckland City Hospital ( Site 1901)

    Auckland, 1023

Other trials in New Zealand

Norway1 site

  • Universitetssykehuset Nord-Norge HF-Kreftavdelingen ( Site 2001)

    Tromsø, Troms, 9038

Other trials in Norway

About this study

Official title: 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.

Being tested
Pembrolizumab, Paclitaxel, Bevacizumab, Placebo for pembrolizumab, Docetaxel
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called MK-3475,, KEYTRUDA®

    IV infusion

  • PaclitaxelDrug

    IV infusion

  • BevacizumabDrug

    Also called AVASTIN®, Zirabev

    IV infusion

  • Placebo for pembrolizumabOther

    Also called normal saline or dextrose

    IV infusion

  • DocetaxelDrug

    Also called TAXOTERE®

    IV infusion

Study groups in NCT05116189
Study groupRoleWhat they receive
Pembrolizumab + paclitaxel ± bevacizumabExperimentalParticipants 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.
Receives: Biological: Pembrolizumab; Drug: Paclitaxel; Drug: Bevacizumab; Drug: Docetaxel
Placebo + paclitaxel ± bevacizumabPlacebo comparatorParticipants 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.
Receives: Drug: Paclitaxel; Drug: Bevacizumab; Other: Placebo for pembrolizumab; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to ~38 months

  2. 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.

    Measured: Up to ~38 months

Secondary outcomes (9)

  1. 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.

    Measured: Up to ~38 months

  2. 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.

    Measured: Up to ~38 months

  3. 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.

    Measured: Up to ~64 months

  4. 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.

    Measured: Up to ~64 months

  5. 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.

    Measured: Up to ~64 months

  6. 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.

    Measured: Baseline and up to ~64 months

  7. 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.

    Measured: Up to ~64 months

  8. 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.

    Measured: Baseline and up to ~64 months

  9. 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.

    Measured: Up to ~64 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2021
  2. Study start13 Dec 2021
  3. Primary completion5 Mar 2025
  4. Study completion16 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
643 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05116189
Sponsor's protocol ID
3475-B96
Other IDs
MK-3475-B96, KEYNOTE-B96, ENGOT-ov65, jRCT2051210184, 2023-506177-35-00, U1111-1287-5318, 2020-005027-37, 2023
Status last verified
Mar 2026
First submitted
28 Oct 2021
Last updated
9 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Lesnock JL, Temin S, Bouberhan S, Adams SF, Barber EL, Burkett WC, Corrales L, Fuh KC, Fujiwara K, Hardesty MM, Lefkowits C, Richardson K, Rimel BJ, Ring KL, Rocconi RP, Rungruang BJ, Scalici JM. Systemic Treatment of Ovarian Cancer Recurrence: ASCO Living Guideline, Version 2026.1.0. J Clin Oncol. 2026 Oct;44(28):2725-2744. doi: 10.1200/JCO-26-01591. Epub 2026 Jul 13.

    PubMed 42441925

  • Colombo N, Zsiros E, Parma G, Rulli E, Sebastianelli A, Bidzinski M, Gallardo C, Matanes E, Hasegawa K, Kose F, Magallanes-Maciel M, Herbertson RA, Ananda S, Kroep JR, de Melo AC, Debruyne PR, Kim JW, Sehouli J, Pierre ME, Hietanen S, Zamagni C, Lu X, Monk BJ, Coleman RL, Peng X, Yamada K, Bogusz AM, De La Motte Rouge T, Wu X; ENGOT-ov65/KEYNOTE-B96 investigators. Pembrolizumab plus weekly paclitaxel in platinum-resistant recurrent ovarian cancer (ENGOT-ov65/KEYNOTE-B96): a multicentre, randomised, double-blind, phase 3 study. Lancet. 2026 Apr 18;407(10538):1525-1537. doi: 10.1016/S0140-6736(26)00602-1. Epub 2026 Apr 10.

    PubMed 41974150

  • 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.

    PubMed 37185961

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab, Paclitaxel and Bevacizumab in people with Ovarian Cancer and Carcinoma, Ovarian Epithelial, run by Merck Sharp & Dohme LLC at 187 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 187 sites in United States, China, Japan, Canada, Germany and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Up to ~38 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05116189, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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