Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)

April 29, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab Versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting (KEYNOTE-C93/GOG-3064/ENGOT-en15)

The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy.

The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

280

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
      • St Leonards, New South Wales, Australia, 2065
        • Northern Cancer Institute ( Site 0206)
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital-Department of Gynaecological Oncology ( Site 0201)
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0205)
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Health ( Site 0202)
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0207)
      • Melbourne, Victoria, Australia, 3002
        • Epworth Freemasons ( Site 0203)
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • St. John of God Subiaco Hospital-Oncology Clinical Trials Unit ( Site 0204)
  • Belgium
    • Bruxelles-Capitale, Region de
      • Brussels, Bruxelles-Capitale, Region de, Belgium, 1000
        • Institut Jules Bordet-Medicine Oncology ( Site 0321)
    • Hainaut
      • Gilly, Hainaut, Belgium, 6060
        • Grand Hôpital de Charleroi - Les Viviers ( Site 0323)
    • Liege
      • Liège, Liege, Belgium, 4000
        • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0320)
  • Brazil
      • São Paulo, Brazil, 01246-000
        • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 3001)
      • São Paulo, Brazil, 01509-010
        • A. C. Camargo Cancer Center-CAPEC ( Site 3003)
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59075-740
        • Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 3005)
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute ( Site 0513)
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • BC Cancer Kelowna ( Site 0517)
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Vancouver-Clinical Trials Unit ( Site 0518)
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0509)
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre ( Site 0510)
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital ( Site 0504)
      • Montreal, Quebec, Canada, H2X 3E4
        • Centre Hospitalier de l'Université de Montréal ( Site 0519)
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre ( Site 0505)
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Center-Clinical Research Department ( Site 0520)
  • Chile
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500921
        • FALP-UIDO ( Site 0602)
      • Santiago, Region M. de Santiago, Chile, 832000
        • Pontificia Universidad Catolica de Chile ( Site 0604)
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Bradfordhill-Clinical Area ( Site 0603)
  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 0730)
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100026
        • Beijing Obstetrics and Gynecology Hospital Capital Medical University ( Site 0740)
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital ( Site 0723)
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer hospital ( Site 0715)
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400038
        • Southwest Hospital of Third Military Medical University ( Site 0719)
      • Chongqing, Chongqing Municipality, China, 400072
        • The Second Affiliated Hospital of Chongqing Medical University ( Site 0745)
      • Fulingqu, Chongqing Municipality, China, 408000
        • Fuling Central Hospital ( Site 0733)
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian Provincial Cancer Hospital ( Site 0720)
    • Guangdong
      • Guangzhou, Guangdong, China, 510700
        • SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 0710)
      • Shantou, Guangdong, China, 515031
        • Cancer Hospital of Shantou University Medical College ( Site 0732)
      • Zhanjiang, Guangdong, China, 524004
        • Affiliated Hospital of Guangdong Medical University ( Site 0731)
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Guangxi Medical University Affiliated Tumor Hospital-Gynecological oncology ( Site 0704)
    • Hainan
      • Haikou, Hainan, China, 570311
        • Hainan General Hospital ( Site 0703)
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Harbin Medical University Cancer Hospital ( Site 0711)
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital ( Site 0713)
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Hospital-Medical Oncology ( Site 0716)
    • Hunan
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital Central South University-Gynecology ( Site 0708)
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital ( Site 0709)
    • Jiangsu
      • Nanjing, Jiangsu, China, 210003
        • Jiangsu Province Hospital-Oncology Department ( Site 0707)
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University ( Site 0729)
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University ( Site 0705)
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Shaanxi Provincial Cancer Hospital ( Site 0714)
    • Shandong
      • Binzhou, Shandong, China, 256603
        • Binzhou Medical University Hospital-Oncology department ( Site 0735)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200011
        • Obstetrics & Gynecology Hospital of Fudan University ( Site 0702)
      • Shanghai, Shanghai Municipality, China, 201204
        • Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 0717)
    • Sichuan
      • Chengdu, Sichuan, China, 610066
        • West China Second University Hospital Sichuan University ( Site 0701)
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Cancer Hospital (Tianjin Medical University Cancer institute & Hospital) ( Site 0706)
    • Yunnan
      • Kunming, Yunnan, China, 650107
        • Yunnan Province Cancer Hospital-Gynecology Department ( Site 0721)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital-Oncology ( Site 0700)
      • Hangzhou, Zhejiang, China, 310000
        • The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 0726)
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University-Gynecology ( Site 0725)
  • Czechia
      • Prague, Czechia, 10034
        • Fakultni nemocnice Kralovske Vinohrady-Gynekologicko-porodnická klinika ( Site 0408)
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 62500
        • Fakultní nemocnice Brno Bohunice-Gynekologicko-porodnicka klinika ( Site 0404)
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 708 52
        • Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 0403)
    • Novy Jicin
      • Nový Jiín, Novy Jicin, Czechia, 741 01
        • Nemocnice AGEL Novy Jicin a.s.-Oddeleni radioterapie a onkologie ( Site 0406)
    • Olomouc Region
      • Olomouc, Olomouc Region, Czechia, 779 00
        • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0402)
    • Praha 2
      • Prague, Praha 2, Czechia, 12808
        • Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 0405)
    • Praha 8
      • Prague, Praha 8, Czechia, 180 00
        • Fakultni nemocnice Bulovka-Gynekologicko-porodnicka klinika ( Site 0401)
    • Zlín
      • Zlín, Zlín, Czechia, 762 75
        • Nemocnice Tomase Bati ve Zline-Onkologické oddělení ( Site 0407)
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2100
        • Rigshospitalet ( Site 0903)
      • Copenhagen, Capital Region, Denmark, 2730
        • Herlev and Gentofte Hospital ( Site 0902)
    • North Denmark
      • Aalborg, North Denmark, Denmark, 9000
        • Aalborg Universitetshospital, Syd ( Site 0905)
    • Region Sjælland
      • Roskilde, Region Sjælland, Denmark, DK-4000
        • Roskilde Sygehus-Oncology department ( Site 0904)
  • Finland
    • Northern Savonia
      • Kuopio, Northern Savonia, Finland, 70200
        • Kuopion Yliopistollinen Sairaala ( Site 1002)
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Tampereen yliopistollinen sairaala-Gynecology and Obstetrics ( Site 1001)
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00290
        • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1003)
  • Germany
      • Berlin, Germany, 13353
        • Charité Campus Virchow-Klinikum ( Site 1103)
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Universitaetsklinikum Ulm. ( Site 1106)
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Universitätsklinikum Bonn-Gynaecological oncology ( Site 1105)
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur ( Site 1101)
  • Hungary
      • Budapest, Hungary, 1122
        • Országos Onkológiai Intézet-Ngyógyászat ( Site 1201)
  • Ireland
      • Cork, Ireland, T12 DV56
        • Bon Secours Cork Hospital ( Site 1305)
      • Dublin, Ireland, D08 E9P6
        • St. James's Hospital-Cancer clinical trials office ( Site 1301)
  • Israel
      • Beersheba, Israel, 8410101
        • Soroka Medical Center ( Site 1403)
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus-Gyneco-oncology unit ( Site 1402)
      • Holon, Israel, 5822012
        • Edith Wolfson Medical Center-Obstetrics & Gynecology ( Site 1405)
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center ( Site 1404)
      • Ramat Gan, Israel, 5265601
        • Sheba Medical Center ( Site 1401)
  • Italy
      • Milan, Italy, 20141
        • Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 1506)
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli-Ginecologia Oncologica ( Site 1502)
    • Campania
      • Naples, Campania, Italy, 80131
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Sperimentale Uro-Genitale ( Site 1501)
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • IRCCS - AOU di Bologna-SSD Oncologia medica Addarii ( Site 1503)
      • Meldola, Emilia-Romagna, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1513)
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 1507)
    • Piedmont
      • Turin, Piedmont, Italy, 10128
        • Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 1514)
    • Roma
      • Rome, Roma, Italy, 00144
        • Istituto Nazionale Tumori Regina Elena-Oncologia Medica 1 ( Site 1504)
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1509)
    • Veneto
      • Vicenza, Veneto, Italy, 36100
        • AULSS8 Berica-Ospedale S.Bortolo-ONCOLOGIA CLINICA ( Site 1510)
  • Japan
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center ( Site 1608)
      • Osaka, Japan, 541-8567
        • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1617)
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East ( Site 1604)
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center ( Site 1611)
      • Tōon, Ehime, Japan, 791-0295
        • Ehime University Hospital ( Site 1614)
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Kurume University Hospital ( Site 1612)
    • Gunma
      • Otashi, Gunma, Japan, 373-8550
        • Gunma Prefectural Cancer Center ( Site 1603)
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital ( Site 1601)
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
        • University of Tsukuba Hospital ( Site 1618)
    • Iwate
      • Shiwa-gun Yahaba-cho, Iwate, Japan, 028-3695
        • Iwate Medical University Hospital ( Site 1602)
    • Niigata
      • Chuo-ku, Niigata, Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital ( Site 1613)
    • Saitama
      • Hidaka-shi, Saitama, Japan, 350-1200
        • Saitama Medical University International Medical Center ( Site 1605)
    • Shizuoka
      • Nagaizumi-cho,Sunto-gun, Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center ( Site 1609)
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital ( Site 1607)
      • Koto, Tokyo, Japan, 135-8550
        • Cancer Institute Hospital of JFCR ( Site 1616)
      • Minato-ku, Tokyo, Japan, 105-8471
        • The Jikei University Hospital ( Site 1615)
      • Shinjyuku-ku, Tokyo, Japan, 160-8582
        • Keio University Hospital ( Site 1606)
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen ( Site 1707)
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1705)
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Radboudumc-Medical Oncology ( Site 1703)
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Maastricht UMC+ ( Site 1709)
    • North Brabant
      • Eindhoven, North Brabant, Netherlands, 5623 EJ
        • Catharina Ziekenhuis-Oncology ( Site 1704)
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105 AZ
        • Amsterdam UMC, locatie AMC ( Site 1706)
    • South Holland
      • Leiden, South Holland, Netherlands, 2333 ZA
        • Leids Universitair Medisch Centrum-Medical Oncology ( Site 1702)
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Erasmus Medisch Centrum-Medical Oncology ( Site 1701)
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital ( Site 1801)
  • Norway
      • Oslo, Norway, 0379
        • Oslo universitetssykehus, Radiumhospitalet ( Site 1901)
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-848
        • Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 2004)
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-090
        • Centrum Onkologii Ziemi Lubelskiej ( Site 2006)
    • Masovian Voivodeship
      • Siedlce, Masovian Voivodeship, Poland, 08-110
        • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2007)
      • Warsaw, Masovian Voivodeship, Poland, 00-315
        • Szpital Kliniczny im. Księżnej Anny Mazowieckiej ( Site 2009)
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Site 2008)
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-027
        • Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2003)
    • Silesian Voivodeship
      • Gliwice, Silesian Voivodeship, Poland, 44-102
        • Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 2002)
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
        • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2010)
  • Russia
    • Moscow Oblast
      • Krasnogorsk, Moscow Oblast, Russia, 143423
        • Moscow City Oncology Hospital #62 ( Site 2204)
    • Yaroslavl Oblast
      • Yaroslavl, Yaroslavl Oblast, Russia, 150054
        • Yaroslavl Regional Cancer Hospital-Oncology ( Site 2202)
  • 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 2301)
      • Seoul, South Korea, 05505
        • Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 2303)
      • Seoul, South Korea, 06273
        • Gangnam Severance Hospital ( Site 2304)
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron ( Site 2403)
      • Seville, Spain, 41013
        • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2401)
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2406)
    • La Coruna
      • A Coruña, La Coruna, Spain, 15006
        • CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2405)
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2402)
    • Navarre
      • Pamplona, Navarre, Spain, 31009
        • COMPLEJO HOSPITALARIO DE NAVARRA ( Site 2407)
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46009
        • Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2404)
  • Sweden
    • Skåne County
      • Lund, Skåne County, Sweden, 22185
        • Skånes Universitetssjukhus Lund-Department of Hematology ( Site 2504)
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 171 64
        • Karolinska Universitetssjukhuset Solna ( Site 2502)
    • Västerbotten County
      • Umeå, Västerbotten County, Sweden, 901 85
        • Norrlands universitetssjukhus-Cancercentrum ( Site 2503)
  • Taiwan
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital ( Site 2602)
      • Tainan, Taiwan, 704
        • NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2604)
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital ( Site 2603)
      • Taipei, Taiwan, 10449
        • Mackay Memorial Hospital ( Site 2601)
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital ( Site 2605)
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Hacettepe Universite Hastaneleri-oncology hospital ( Site 2704)
      • Ankara, Turkey (Türkiye), 06800
        • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2706)
      • Antalya, Turkey (Türkiye), 07070
        • Akdeniz Universitesi Hastanesi ( Site 2701)
      • Istanbul, Turkey (Türkiye), 34093
        • Istanbul University Capa Campus-department of obstetrics and gynaecology ( Site 2705)
    • Istanbul
      • Fatih, Istanbul, Turkey (Türkiye), 34098
        • Istanbul Universitesi Cerrahpasa ( Site 2702)
  • United Kingdom
    • England
      • Manchester, England, United Kingdom, M20 4BX
        • The Christie ( Site 2807)
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G12 0YN
        • The Beatson West of Scotland Cancer Centre ( Site 2805)
    • London, City of
      • London, London, City of, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital ( Site 2804)
      • London, London, City of, United Kingdom, SW3 6JJ
        • ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2806)
      • London, London, City of, United Kingdom, W12 OHS
        • Hammersmith Hospital-Medical Oncology ( Site 2808)
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • HonorHealth-USOR HonorHealth ( Site 8000)
    • California
      • La Jolla, California, United States, 92093-0698
        • Moores Cancer Center ( Site 0037)
      • Riverside, California, United States, 92505
        • Kaiser Permanente Riverside Medical Center ( Site 0045)
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0013)
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Cancer Center ( Site 0018)
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Heath Care System ( Site 0005)
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital ( Site 0017)
      • Newnan, Georgia, United States, 30265
        • Southeastern Regional Medical Center ( Site 0046)
    • Illinois
      • Zion, Illinois, United States, 60099
        • Midwestern Regional Medical Center,Inc. DBA CTCA, Chicago ( Site 0003)
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Hospital and Health Care Center, Inc ( Site 0006)
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington ( Site 0042)
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Maryland Oncology Hematology, P.A.-USOR Maryland Oncology Hematology, P.A. ( Site 8002)
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • University of Massachusetts Medical School-Division of Gynecologic Oncology ( Site 0008)
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute ( Site 0029)
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • St. Dominic's Hospital ( Site 0024)
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0026)
    • New York
      • New York, New York, United States, 10011
        • The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0023)
      • New York, New York, United States, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0016)
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai ( Site 0052)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center ( Site 0009)
    • North Carolina
      • Pinehurst, North Carolina, United States, 28374
        • FirstHealth Clinical Trials ( Site 0050)
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Sanford Medical Center ( Site 0054)
      • Fargo, North Dakota, United States, 58102
        • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0055)
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0039)
      • Columbus, Ohio, United States, 43210
        • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0027)
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center ( Site 0031)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Sidney Kimmel Cancer Center - Jefferson Health ( Site 0053)
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0034)
      • Pittsburgh, Pennsylvania, United States, 15224
        • AHN West Penn Hospital ( Site 0011)
      • Willow Grove, Pennsylvania, United States, 19090
        • Asplundh Cancer Pavilion ( Site 0014)
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center-Gynecologic Oncology ( Site 0002)
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Oncology - Austin-USOR Texas Oncology - Austin ( Site 8003)
      • Dallas, Texas, United States, 75246
        • Texas Oncology - Dallas-USOR Texas Oncology - Dallas (Sammons) ( Site 8005)
      • Tyler, Texas, United States, 75702
        • Texas Oncology - Tyler-USOR Texas Oncology - Northeast Texas ( Site 8004)
    • Virginia
      • Richmond, Virginia, United States, 23219
        • VCU Health Adult Outpatient Pavillion ( Site 0022)

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

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

  • Has a histologically confirmed diagnosis of inoperable, Stage III or IV or recurrent Endometrial Carcinoma (EC) or carcinosarcoma (mixed Mullerian tumor) that is centrally confirmed as dMMR.
  • Has radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1, as assessed by the investigator. Note: primary Stage IVB that has undergone surgical resection is allowed regardless of presence of measurable or evaluable disease.

  • Has received no prior systemic therapy for EC except for the following:

    1. May have received 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent resection if the recurrence occurred ≥6 months after the last dose of chemotherapy.
    2. May have received prior radiation with or without radiosensitizing chemotherapy if >2 weeks before the start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
    3. May have received prior hormonal therapy for treatment of EC, provided that it was discontinued ≥1 week prior to randomization.
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
  • Is not pregnant or breastfeeding and agrees to not donate eggs and use a highly effective contraceptive method for 120 days after the last dose of pembrolizumab or 180 days after the last dose of chemotherapy if a woman of childbearing potential (WOCBP).
  • Has a negative highly sensitive pregnancy test (urine or serum) within 24 hours for urine or 72 hours for serum before the first dose of study intervention if a WOCBP.
  • Provides an archival tumor tissue sample or newly obtained (core, incisional, or excisional) biopsy of a tumor lesion not previously irradiated for verification of dMMR status and histology.
  • If Hepatitis B surface antigen (HBsAg) positive, has received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load prior to randomization.
  • If has a history of Hepatitis C virus (HCV) infection, has undetectable HCV viral load at screening.

Exclusion Criteria:

  • Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas and neuroendocrine tumors are not allowed.
  • Has EC of any histology that is proficient mismatch repair (pMMR).
  • Is a candidate for curative-intent surgery or curative-intent radiotherapy.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137]).
  • Has received prior systemic anticancer therapy including investigational agents for any advanced or metastatic EC. (Note: Prior chemotherapy administered as adjuvant therapy, neoadjuvant therapy, and/or concurrently with radiation is permitted.
  • Has had a major operation and has not recovered adequately from the procedure and/or any complications from the operation before starting study intervention.
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
  • Is currently participating in or has participated in a study of an investigational agent for EC, has participated in a study of an investigational agent for non-EC within 4 weeks before the first dose of study intervention, or has used an investigational device within 4 weeks before the first dose of study intervention.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy are not excluded.
  • Has known active CNS metastases and/or carcinomatous meningitis.
  • Has a known intolerance to any study intervention and/or any of its excipients.
  • Has an active autoimmune disease that has required systemic treatment in 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 had an allogenic tissue/solid organ transplant.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab
Participants receive pembrolizumab 400 mg via IV infusion on Day 1 of each 6-week cycle (Q6W) for up to 18 cycles (up to approximately 2 years).
Biological: pembrolizumab
Intravenous (IV) infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Active Comparator: Carboplatin+paclitaxel
Participants receive a combination of paclitaxel 175 mg/m^2 on Day 1 of each 3-week cycle (Q3W) and carboplatin AUC 5 or 6 on Day 1 Q3W for 6 cycles (up to approximately 4 months). Participants who experience a severe hypersensitivity reaction to paclitaxel or an adverse event (AE) requiring discontinuation of paclitaxel may receive docetaxel 75 mg/m^2 in place of paclitaxel on Day 1 Q3W after Sponsor consultation. Participants who experience a severe hypersensitivity reaction to carboplatin or an AE requiring discontinuation of carboplatin may receive cisplatin 75 mg/m^2 in place of carboplatin on Day 1 Q3W after Sponsor consultation.
Drug: paclitaxel
IV infusion
Other Names:
  • TAXOL®
Drug: docetaxel
IV infusion
Other Names:
  • TAXOTERE®
Drug: carboplatin
IV infusion
Other Names:
  • PARAPLATIN®
Drug: cisplatin
IV infusion
Other Names:
  • PLATINOL-AQ®

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 Blinded Independent Central Review (BICR)
Time Frame: Up to approximately 45 months
PFS is defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 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 lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by BICR will be reported for participants.
Up to approximately 45 months
Overall Survival
Time Frame: Up to approximately 59 months
OS is defined as the time from randomization to death due to any cause. The OS will be reported for all participants.
Up to approximately 59 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience at Least One Adverse Event (AE)
Time Frame: Up to approximately 27 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE will be reported.
Up to approximately 27 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Time Frame: Up to approximately 24 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 24 months
Change From Baseline in European Organization for Research And Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) (Item 29) And Quality of Life (QoL) (Item 30) Combined Score
Time Frame: Baseline and up to approximately 25 months
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 approximately 25 months
Change From Baseline in European Organization for Research And Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Combined Score
Time Frame: Baseline and up to approximately 25 months
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning 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 Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented. A higher score indicates a better quality of life.
Baseline and up to approximately 25 months
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to approximately 45 months
ORR is defined as the percentage of participants who have a best response of confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.
Up to approximately 45 months
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to approximately 45 months
DCR is defined, per RECIST 1.1, as the percentage of participants who have achieved Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or demonstrated Stable Disease (SD) for at least 24 weeks. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.) The DCR as assessed by BICR will be presented.
Up to approximately 45 months
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to approximately 45 months
DOR is defined as the time from first documented evidence of CR or PR until the first documented date of disease progression (PD) or death due to any cause, whichever occurs first, for participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. Per RECIST 1.1, PD is defined as at least a 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Up to approximately 45 months
Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Time Frame: Up to approximately 45 months
PFS is defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 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 lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by investigator will be reported for participants.
Up to approximately 45 months
Progression-Free Survival 2 (PFS2) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Time Frame: Up to approximately 45 months
PFS2 is defined as the time from randomization to subsequent disease progression (PD) per RECIST 1.1 after initiation of a new anticancer therapy, 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 lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS2 per RECIST 1.1 as assessed by investigator will be reported for participants.
Up to approximately 45 months

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

Collaborators

GOG Foundation
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.

General Publications

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)

February 3, 2022

Primary Completion (Estimated)

May 27, 2027

Study Completion (Estimated)

May 27, 2027

Study Registration Dates

First Submitted

December 20, 2021

First Submitted That Met QC Criteria

December 20, 2021

First Posted (Actual)

December 30, 2021

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3475-C93
  • MK-3475-C93 (Other Identifier: MSD)
  • KEYNOTE-C93 (Other Identifier: MSD)
  • GOG-3064 (Other Identifier: Gynecologic Oncology Group (GOG))
  • ENGOT-en15 (Other Identifier: European Network of Gynaecological Oncological Trial Groups (ENGOT))
  • jRCT2011210065 (Registry Identifier: jRCT)
  • 2021-003185-12 (EudraCT Number)
  • 2023-506361-56-00 (Registry Identifier: EU CT)
  • U1111-1292-6057 (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.

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