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ACTIVE NOT RECRUITING
NCT05173987
PHASE3

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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).

Official title: 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)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2022-02-03

Completion Date

2027-05-27

Last Updated

2024-11-21

Healthy Volunteers

No

Interventions

BIOLOGICAL

pembrolizumab

Intravenous (IV) infusion

DRUG

carboplatin

IV infusion

DRUG

paclitaxel

IV infusion

DRUG

docetaxel

IV infusion

DRUG

cisplatin

IV infusion

Locations (195)

HonorHealth-USOR HonorHealth ( Site 8000)

Phoenix, Arizona, United States

Moores Cancer Center ( Site 0037)

La Jolla, California, United States

Kaiser Permanente Riverside Medical Center ( Site 0045)

Riverside, California, United States

Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0013)

New Haven, Connecticut, United States

Mount Sinai Cancer Center ( Site 0018)

Miami Beach, Florida, United States

Sarasota Memorial Hospital ( Site 0005)

Sarasota, Florida, United States

Northside Hospital ( Site 0017)

Atlanta, Georgia, United States

Southeastern Regional Medical Center ( Site 0046)

Newnan, Georgia, United States

Midwestern Regional Medical Center,Inc. DBA CTCA, Chicago ( Site 0003)

Zion, Illinois, United States

St. Vincent Hospital and Health Care Center, Inc ( Site 0006)

Indianapolis, Indiana, United States

Baptist Health Lexington ( Site 0042)

Lexington, Kentucky, United States

Maryland Oncology Hematology, P.A.-USOR Maryland Oncology Hematology, P.A. ( Site 8002)

Rockville, Maryland, United States

University of Massachusetts Medical School-Division of Gynecologic Oncology ( Site 0008)

Worcester, Massachusetts, United States

Karmanos Cancer Institute ( Site 0029)

Detroit, Michigan, United States

St. Dominic's Hospital ( Site 0024)

Jackson, Mississippi, United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0026)

Hackensack, New Jersey, United States

The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0023)

New York, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0016)

New York, New York, United States

Icahn School of Medicine at Mount Sinai ( Site 0052)

New York, New York, United States

Memorial Sloan Kettering Cancer Center ( Site 0009)

New York, New York, United States

FirstHealth Clinical Trials ( Site 0050)

Pinehurst, North Carolina, United States

Sanford Medical Center ( Site 0054)

Bismarck, North Dakota, United States

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0055)

Fargo, North Dakota, United States

University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0039)

Cincinnati, Ohio, United States

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C

Columbus, Ohio, United States

Providence Portland Medical Center ( Site 0031)

Portland, Oregon, United States

Sidney Kimmel Cancer Center - Jefferson Health ( Site 0053)

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0034)

Pittsburgh, Pennsylvania, United States

AHN West Penn Hospital ( Site 0011)

Pittsburgh, Pennsylvania, United States

Asplundh Cancer Pavilion ( Site 0014)

Willow Grove, Pennsylvania, United States

Sanford Cancer Center-Gynecologic Oncology ( Site 0002)

Sioux Falls, South Dakota, United States

Texas Oncology - Austin-USOR Texas Oncology - Austin ( Site 8003)

Austin, Texas, United States

Texas Oncology - Dallas-USOR Texas Oncology - Dallas (Sammons) ( Site 8005)

Dallas, Texas, United States

Texas Oncology - Tyler-USOR Texas Oncology - Northeast Texas ( Site 8004)

Tyler, Texas, United States

VCU Health Adult Outpatient Pavillion ( Site 0022)

Richmond, Virginia, United States

Northern Cancer Institute ( Site 0206)

St Leonards, New South Wales, Australia

Westmead Hospital-Department of Gynaecological Oncology ( Site 0201)

Westmead, New South Wales, Australia

Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si

Brisbane, Queensland, Australia

Monash Health ( Site 0202)

Clayton, Victoria, Australia

Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0207)

Melbourne, Victoria, Australia

Epworth Freemasons ( Site 0203)

Melbourne, Victoria, Australia

St. John of God Subiaco Hospital-Oncology Clinical Trials Unit ( Site 0204)

Subiaco, Western Australia, Australia

Institut Jules Bordet-Medicine Oncology ( Site 0321)

Brussels, Bruxelles-Capitale, Region de, Belgium

Grand Hôpital de Charleroi-Oncology & Hematology ( Site 0323)

Charleroi, Hainaut, Belgium

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0320)

Liège, Liege, Belgium

Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 3005)

Natal, Rio Grande do Norte, Brazil

ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 3001)

São Paulo, São Paulo, Brazil

A. C. Camargo Cancer Center-CAPEC ( Site 3003)

São Paulo, Brazil

Cross Cancer Institute ( Site 0513)

Edmonton, Alberta, Canada

BC Cancer Kelowna ( Site 0517)

Kelowna, British Columbia, Canada

BC Cancer Vancouver-Clinical Trials Unit ( Site 0518)

Vancouver, British Columbia, Canada

Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0509)

Toronto, Ontario, Canada

Princess Margaret Cancer Centre ( Site 0510)

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal ( Site 0519)

Montreal, Quebec, Canada

Jewish General Hospital ( Site 0504)

Montreal, Quebec, Canada

McGill University Health Centre ( Site 0505)

Montreal, Quebec, Canada

Saskatoon Cancer Center-Clinical Research Department ( Site 0520)

Saskatoon, Saskatchewan, Canada

FALP-UIDO ( Site 0602)

Santiago, Region M. de Santiago, Chile

Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0604)

Santiago, Region M. de Santiago, Chile

Bradfordhill-Clinical Area ( Site 0603)

Santiago, Region M. de Santiago, Chile

Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 0730)

Hefei, Anhui, China

Beijing Obstetric and Gynecology Hospital ( Site 0740)

Beijing, Beijing Municipality, China

Peking University First Hospital ( Site 0723)

Beijing, Beijing Municipality, China

Beijing Cancer hospital ( Site 0715)

Beijing, Beijing Municipality, China

Southwest Hospital of Third Military Medical University ( Site 0719)

Chongqing, Chongqing Municipality, China

2nd Affiliated Hospital Chongqing Medical Universi ( Site 0745)

Chongqing, Chongqing Municipality, China

Fuling Central Hospital ( Site 0733)

Fulingqu, Chongqing Municipality, China

Fujian Provincial Cancer Hospital ( Site 0720)

Fuzhou, Fujian, China

SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 0710)

Guangzhou, Guangdong, China

Cancer Hospital of Shantou University Medical College ( Site 0732)

Shantou, Guangdong, China

Affiliated Hospital of Guangdong Medical College ( Site 0731)

Zhanjiang, Guangdong, China

Guangxi Medical University Affiliated Tumor Hospital-Gynecological oncology ( Site 0704)

Nanning, Guangxi, China

Hainan General Hospital ( Site 0703)

Haikou, Hainan, China

Harbin Medical University Cancer Hospital ( Site 0711)

Harbin, Heilongjiang, China

Henan Cancer Hospital ( Site 0713)

Zhengzhou, Henan, China

Wuhan Union Hospital-Medical Oncology ( Site 0716)

Wuhan, Hubei, China

Xiangya Hospital Central South University-Gynecology ( Site 0708)

Changsha, Hunan, China

Hunan Cancer Hospital ( Site 0709)

Changsha, Hunan, China

Jiangsu Province Hospital-Oncology Department ( Site 0707)

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanchang University ( Site 0729)

Nanchang, Jiangxi, China

The First Hospital of Jilin University ( Site 0705)

Changchun, Jilin, China

Shaanxi Provincial Cancer Hospital ( Site 0714)

Xi'an, Shaanxi, China

Binzhou Medical University Hospital-Oncology department ( Site 0735)

Binzhou, Shandong, China

Obstetrics & Gynecology Hospital of Fudan University ( Site 0702)

Shanghai, Shanghai Municipality, China

Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 0717)

Shanghai, Shanghai Municipality, China

West China Second University Hospital Sichuan University ( Site 0701)

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital ( Site 0706)

Tianjin, Tianjin Municipality, China

Yunnan Province Cancer Hospital-Gynecology Department ( Site 0721)

Kunming, Yunnan, China

The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 0726)

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital-Oncology ( Site 0700)

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University-Gynecology ( Site 0725)

Wenzhou, Zhejiang, China

Fakultní nemocnice Brno Bohunice-Gynekologicko-porodnicka klinika ( Site 0404)

Brno, Brno-mesto, Czechia

Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 0403)

Ostrava, Moravskoslezský kraj, Czechia

Nemocnice AGEL Novy Jicin a.s.-Oddeleni radioterapie a onkologie ( Site 0406)

Nový Jiín, Novy Jicin, Czechia

Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0402)

Olomouc, Olomoucký kraj, Czechia

Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 0405)

Prague, Praha 2, Czechia

Fakultni nemocnice Bulovka-Gynekologicko-porodnicka klinika ( Site 0401)

Prague, Praha 8, Czechia

Nemocnice Tomase Bati ve Zline-Onkologické oddělení ( Site 0407)

Zlín, Zlín, Czechia

Fakultni nemocnice Kralovske Vinohrady-Gynekologicko-porodnická klinika ( Site 0408)

Prague, Czechia

Rigshospitalet ( Site 0903)

Copenhagen, Capital Region, Denmark

Herlev and Gentofte Hospital ( Site 0902)

Copenhagen, Capital Region, Denmark

Aalborg Universitetshospital, Syd ( Site 0905)

Aalborg, North Denmark, Denmark

Roskilde Sygehus-Oncology department ( Site 0904)

Roskilde, Region Sjælland, Denmark

Kuopion Yliopistollinen Sairaala ( Site 1002)

Kuopio, Northern Savonia, Finland

Tampereen yliopistollinen sairaala-Gynecology and Obstetrics ( Site 1001)

Tampere, Pirkanmaa, Finland

Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1003)

Helsinki, Uusimaa, Finland

Universitaetsklinikum Ulm ( Site 1106)

Ulm, Baden-Wurttemberg, Germany

Universitätsklinikum Bonn-Gynaecological oncology ( Site 1105)

Bonn, North Rhine-Westphalia, Germany

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

Dresden, Saxony, Germany

Charité Campus Virchow-Klinikum ( Site 1103)

Berlin, Germany

Országos Onkológiai Intézet-Ngyógyászat ( Site 1201)

Budapest, Hungary

Bon Secours Cork Hospital ( Site 1305)

Cork, Ireland

St. James's Hospital-Cancer clinical trials office ( Site 1301)

Dublin, Ireland

Soroka Medical Center ( Site 1403)

Beersheba, Israel

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

Haifa, Israel

Edith Wolfson Medical Center-Obstetrics & Gynecology ( Site 1405)

Holon, Israel

Shaare Zedek Medical Center ( Site 1404)

Jerusalem, Israel

Sheba Medical Center ( Site 1401)

Ramat Gan, Israel

Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Sperimentale Uro-Genitale ( Site 1

Naples, Campania, Italy

IRCCS - AOU di Bologna-SSD Oncologia medica Addarii ( Site 1503)

Bologna, Emilia-Romagna, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1513)

Meldola, Emilia-Romagna, Italy

Fondazione Policlinico Universitario Agostino Gemelli-Ginecologia Oncologica ( Site 1502)

Rome, Lazio, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 150

Milan, Lombardy, Italy

Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 1514)

Turin, Piedmont, Italy

Istituto Nazionale Tumori Regina Elena-Oncologia Medica 1 ( Site 1504)

Rome, Roma, Italy

Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1509)

Florence, Tuscany, Italy

AULSS8 Berica-Ospedale S.Bortolo-ONCOLOGIA CLINICA ( Site 1510)

Vicenza, Veneto, Italy

Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 1506)

Milan, Italy

National Cancer Center Hospital East ( Site 1604)

Kashiwa, Chiba, Japan

National Hospital Organization Shikoku Cancer Center ( Site 1611)

Matsuyama, Ehime, Japan

Ehime University Hospital ( Site 1614)

Tōon, Ehime, Japan

Kurume University Hospital ( Site 1612)

Kurume, Fukuoka, Japan

Gunma Prefectural Cancer Center-Gynecology ( Site 1603)

Ōta, Gunma, Japan

Hokkaido University Hospital ( Site 1601)

Sapporo, Hokkaido, Japan

Tsukuba University Hospital ( Site 1618)

Tsukuba, Ibaraki, Japan

Iwate Medical University Hospital ( Site 1602)

Shiwa-gun Yahaba-cho, Iwate, Japan

Niigata University Medical & Dental Hospital ( Site 1613)

Chuo-ku, Niigata, Niigata, Japan

Saitama Medical University International Medical Center ( Site 1605)

Hidaka-shi, Saitama, Japan

Shizuoka Cancer Center ( Site 1609)

Nagaizumi-cho,Sunto-gun, Shizuoka, Japan

National Cancer Center Hospital ( Site 1607)

Chuo-ku, Tokyo, Japan

Japanese Foundation for Cancer Research ( Site 1616)

Koto, Tokyo, Japan

The Jikei University Hospital ( Site 1615)

Minato-ku, Tokyo, Japan

Keio university hospital ( Site 1606)

Shinjyuku-ku, Tokyo, Japan

National Hospital Organization Kyushu Cancer Center ( Site 1608)

Fukuoka, Japan

Osaka International Cancer Institute ( Site 1617)

Osaka, Japan

Radboudumc-Medical Oncology ( Site 1703)

Nijmegen, Gelderland, Netherlands

Maastricht UMC+ ( Site 1709)

Maastricht, Limburg, Netherlands

Catharina Ziekenhuis-Oncology ( Site 1704)

Eindhoven, North Brabant, Netherlands

Amsterdam UMC, locatie AMC ( Site 1706)

Amsterdam, North Holland, Netherlands

Leids Universitair Medisch Centrum-Medical Oncology ( Site 1702)

Leiden, South Holland, Netherlands

Erasmus Medisch Centrum-Medical Oncology ( Site 1701)

Rotterdam, South Holland, Netherlands

University Medical Center Groningen ( Site 1707)

Groningen, Netherlands

Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1705)

Utrecht, Netherlands

Auckland City Hospital-Cancer & Blood Research ( Site 1801)

Auckland, New Zealand

Oslo universitetssykehus, Radiumhospitalet ( Site 1901)

Oslo, Norway

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

Poznan, Greater Poland Voivodeship, Poland

Centrum Onkologii Ziemi Lubelskiej ( Site 2006)

Lublin, Lublin Voivodeship, Poland

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2007)

Siedlce, Masovian Voivodeship, Poland

Szpital Kliniczny im. Księżnej Anny Mazowieckiej ( Site 2009)

Warsaw, Masovian Voivodeship, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Sit

Warsaw, Masovian Voivodeship, Poland

Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2003)

Bialystok, Podlaskie Voivodeship, Poland

Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 20

Gliwice, Silesian Voivodeship, Poland

Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2010)

Kielce, Świętokrzyskie Voivodeship, Poland

Moscow City Oncology Hospital #62 ( Site 2204)

Krasnogorsk, Moscow Oblast, Russia

Yaroslavl Regional Cancer Hospital-Oncology ( Site 2202)

Yaroslavl, Yaroslavl Oblast, Russia

Seoul National University Hospital ( Site 2302)

Seoul, South Korea

Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 2301)

Seoul, South Korea

Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 2303)

Seoul, South Korea

Gangnam Severance Hospital ( Site 2304)

Seoul, South Korea

Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2406)

Hospitalet, Barcelona, Spain

CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2405)

A Coruña, La Coruna, Spain

Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2402)

Madrid, Madrid, Comunidad de, Spain

COMPLEJO HOSPITALARIO DE NAVARRA ( Site 2407)

Pamplona, Navarre, Spain

Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2404)

Valencia, Valenciana, Comunitat, Spain

Hospital Universitari Vall d'Hebron ( Site 2403)

Barcelona, Spain

HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2401)

Seville, Spain

Skånes Universitetssjukhus Lund-Department of Hematology ( Site 2504)

Lund, Skåne County, Sweden

Karolinska Universitetssjukhuset Solna ( Site 2502)

Solna, Stockholm County, Sweden

Norrlands universitetssjukhus-Cancercentrum ( Site 2503)

Umeå, Västerbotten County, Sweden

Taichung Veterans General Hospital ( Site 2602)

Taichung, Taiwan

NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2604)

Tainan, Taiwan

National Taiwan University Hospital ( Site 2603)

Taipei, Taiwan

Mackay Memorial Hospital ( Site 2601)

Taipei, Taiwan

Taipei Veterans General Hospital ( Site 2605)

Taipei, Taiwan

Istanbul Universitesi Cerrahpasa ( Site 2702)

Fatih, Istanbul, Turkey (Türkiye)

Hacettepe Universite Hastaneleri-oncology hospital ( Site 2704)

Ankara, Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2706)

Ankara, Turkey (Türkiye)

Akdeniz Universitesi Hastanesi ( Site 2701)

Antalya, Turkey (Türkiye)

Istanbul University Capa Campus-department of obstetrics and gynaecology ( Site 2705)

Istanbul, Turkey (Türkiye)

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

Istanbul, Turkey (Türkiye)

St Bartholomew's Hospital ( Site 2804)

London, England, United Kingdom

The Christie ( Site 2807)

Manchester, England, United Kingdom

The Beatson West of Scotland Cancer Centre ( Site 2805)

Glasgow, Glasgow City, United Kingdom

ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2806)

London, London, City of, United Kingdom

Hammersmith Hospital-Medical Oncology ( Site 2808)

London, London, City of, United Kingdom