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)
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)
9 other identifiers
interventional
280
27 countries
194
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2022
Longer than P75 for phase_3
194 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2021
CompletedFirst Posted
Study publicly available on registry
December 30, 2021
CompletedStudy Start
First participant enrolled
February 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 27, 2027
May 5, 2026
April 1, 2026
5.3 years
December 20, 2021
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
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
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 Outcomes (9)
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)
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)
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)
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
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
Up to approximately 45 months
- +4 more secondary outcomes
Study Arms (2)
Pembrolizumab
EXPERIMENTALParticipants 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).
Carboplatin+paclitaxel
ACTIVE COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may not qualify if:
- 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:
- 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.
- 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.
- 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.
- 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.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GOG Foundationcollaborator
- Merck Sharp & Dohme LLClead
- European Network of Gynaecological Oncological Trial Groups (ENGOT)collaborator
Study Sites (194)
HonorHealth-USOR HonorHealth ( Site 8000)
Phoenix, Arizona, 85016, United States
Moores Cancer Center ( Site 0037)
La Jolla, California, 92093-0698, United States
Kaiser Permanente Riverside Medical Center ( Site 0045)
Riverside, California, 92505, United States
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0013)
New Haven, Connecticut, 06511, United States
Mount Sinai Cancer Center ( Site 0018)
Miami Beach, Florida, 33140, United States
Sarasota Memorial Heath Care System ( Site 0005)
Sarasota, Florida, 34239, United States
Northside Hospital ( Site 0017)
Atlanta, Georgia, 30342, United States
Southeastern Regional Medical Center ( Site 0046)
Newnan, Georgia, 30265, United States
Midwestern Regional Medical Center,Inc. DBA CTCA, Chicago ( Site 0003)
Zion, Illinois, 60099, United States
St. Vincent Hospital and Health Care Center, Inc ( Site 0006)
Indianapolis, Indiana, 46260, United States
Baptist Health Lexington ( Site 0042)
Lexington, Kentucky, 40503, United States
Maryland Oncology Hematology, P.A.-USOR Maryland Oncology Hematology, P.A. ( Site 8002)
Rockville, Maryland, 20850, United States
University of Massachusetts Medical School-Division of Gynecologic Oncology ( Site 0008)
Worcester, Massachusetts, 01605, United States
Karmanos Cancer Institute ( Site 0029)
Detroit, Michigan, 48201, United States
St. Dominic's Hospital ( Site 0024)
Jackson, Mississippi, 39216, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0026)
Hackensack, New Jersey, 07601, United States
The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0023)
New York, New York, 10011, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0016)
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai ( Site 0052)
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center ( Site 0009)
New York, New York, 10065, United States
FirstHealth Clinical Trials ( Site 0050)
Pinehurst, North Carolina, 28374, United States
Sanford Medical Center ( Site 0054)
Bismarck, North Dakota, 58501, United States
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0055)
Fargo, North Dakota, 58102, United States
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0039)
Cincinnati, Ohio, 45219, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0027)
Columbus, Ohio, 43210, United States
Providence Portland Medical Center ( Site 0031)
Portland, Oregon, 97213, United States
Sidney Kimmel Cancer Center - Jefferson Health ( Site 0053)
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0034)
Pittsburgh, Pennsylvania, 15213, United States
AHN West Penn Hospital ( Site 0011)
Pittsburgh, Pennsylvania, 15224, United States
Asplundh Cancer Pavilion ( Site 0014)
Willow Grove, Pennsylvania, 19090, United States
Sanford Cancer Center-Gynecologic Oncology ( Site 0002)
Sioux Falls, South Dakota, 57104, United States
Texas Oncology - Austin-USOR Texas Oncology - Austin ( Site 8003)
Austin, Texas, 78731, United States
Texas Oncology - Dallas-USOR Texas Oncology - Dallas (Sammons) ( Site 8005)
Dallas, Texas, 75246, United States
Texas Oncology - Tyler-USOR Texas Oncology - Northeast Texas ( Site 8004)
Tyler, Texas, 75702, United States
VCU Health Adult Outpatient Pavillion ( Site 0022)
Richmond, Virginia, 23219, United States
Northern Cancer Institute ( Site 0206)
St Leonards, New South Wales, 2065, Australia
Westmead Hospital-Department of Gynaecological Oncology ( Site 0201)
Westmead, New South Wales, 2145, Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0205)
Brisbane, Queensland, 4029, Australia
Monash Health ( Site 0202)
Clayton, Victoria, 3168, Australia
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0207)
Melbourne, Victoria, 3000, Australia
Epworth Freemasons ( Site 0203)
Melbourne, Victoria, 3002, Australia
St. John of God Subiaco Hospital-Oncology Clinical Trials Unit ( Site 0204)
Subiaco, Western Australia, 6008, Australia
Institut Jules Bordet-Medicine Oncology ( Site 0321)
Brussels, Bruxelles-Capitale, Region de, 1000, Belgium
Grand Hôpital de Charleroi - Les Viviers ( Site 0323)
Gilly, Hainaut, 6060, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0320)
Liège, Liege, 4000, Belgium
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 3005)
Natal, Rio Grande do Norte, 59075-740, Brazil
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 3001)
São Paulo, 01246-000, Brazil
A. C. Camargo Cancer Center-CAPEC ( Site 3003)
São Paulo, 01509-010, Brazil
Cross Cancer Institute ( Site 0513)
Edmonton, Alberta, T6G 1Z2, Canada
BC Cancer Kelowna ( Site 0517)
Kelowna, British Columbia, V1Y 5L3, Canada
BC Cancer Vancouver-Clinical Trials Unit ( Site 0518)
Vancouver, British Columbia, V5Z 4E6, Canada
Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0509)
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Centre ( Site 0510)
Toronto, Ontario, M5G 2M9, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0519)
Montreal, Quebec, H2X 3E4, Canada
Jewish General Hospital ( Site 0504)
Montreal, Quebec, H3T 1E2, Canada
McGill University Health Centre ( Site 0505)
Montreal, Quebec, H4A 3J1, Canada
Saskatoon Cancer Center-Clinical Research Department ( Site 0520)
Saskatoon, Saskatchewan, S7N 4H4, Canada
FALP-UIDO ( Site 0602)
Santiago, Region M. de Santiago, 7500921, Chile
Pontificia Universidad Catolica de Chile ( Site 0604)
Santiago, Region M. de Santiago, 832000, Chile
Bradfordhill-Clinical Area ( Site 0603)
Santiago, Region M. de Santiago, 8420383, Chile
Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 0730)
Hefei, Anhui, 230001, China
Beijing Obstetrics and Gynecology Hospital Capital Medical University ( Site 0740)
Beijing, Beijing Municipality, 100026, China
Peking University First Hospital ( Site 0723)
Beijing, Beijing Municipality, 100034, China
Beijing Cancer hospital ( Site 0715)
Beijing, Beijing Municipality, 100142, China
Southwest Hospital of Third Military Medical University ( Site 0719)
Chongqing, Chongqing Municipality, 400038, China
The Second Affiliated Hospital of Chongqing Medical University ( Site 0745)
Chongqing, Chongqing Municipality, 400072, China
Fuling Central Hospital ( Site 0733)
Fulingqu, Chongqing Municipality, 408000, China
Fujian Provincial Cancer Hospital ( Site 0720)
Fuzhou, Fujian, 350014, China
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 0710)
Guangzhou, Guangdong, 510700, China
Cancer Hospital of Shantou University Medical College ( Site 0732)
Shantou, Guangdong, 515031, China
Affiliated Hospital of Guangdong Medical University ( Site 0731)
Zhanjiang, Guangdong, 524004, China
Guangxi Medical University Affiliated Tumor Hospital-Gynecological oncology ( Site 0704)
Nanning, Guangxi, 530021, China
Hainan General Hospital ( Site 0703)
Haikou, Hainan, 570311, China
Harbin Medical University Cancer Hospital ( Site 0711)
Harbin, Heilongjiang, 150000, China
Henan Cancer Hospital ( Site 0713)
Zhengzhou, Henan, 450008, China
Wuhan Union Hospital-Medical Oncology ( Site 0716)
Wuhan, Hubei, 430022, China
Xiangya Hospital Central South University-Gynecology ( Site 0708)
Changsha, Hunan, 410008, China
Hunan Cancer Hospital ( Site 0709)
Changsha, Hunan, 410013, China
Jiangsu Province Hospital-Oncology Department ( Site 0707)
Nanjing, Jiangsu, 210003, China
The First Affiliated Hospital of Nanchang University ( Site 0729)
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University ( Site 0705)
Changchun, Jilin, 130021, China
Shaanxi Provincial Cancer Hospital ( Site 0714)
Xi'an, Shaanxi, 710061, China
Binzhou Medical University Hospital-Oncology department ( Site 0735)
Binzhou, Shandong, 256603, China
Obstetrics & Gynecology Hospital of Fudan University ( Site 0702)
Shanghai, Shanghai Municipality, 200011, China
Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 0717)
Shanghai, Shanghai Municipality, 201204, China
West China Second University Hospital Sichuan University ( Site 0701)
Chengdu, Sichuan, 610066, China
Tianjin Cancer Hospital (Tianjin Medical University Cancer institute & Hospital) ( Site 0706)
Tianjin, Tianjin Municipality, 300060, China
Yunnan Province Cancer Hospital-Gynecology Department ( Site 0721)
Kunming, Yunnan, 650107, China
The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 0726)
Hangzhou, Zhejiang, 310000, China
Zhejiang Cancer Hospital-Oncology ( Site 0700)
Hangzhou, Zhejiang, 310022, China
The First Affiliated Hospital of Wenzhou Medical University-Gynecology ( Site 0725)
Wenzhou, Zhejiang, 325000, China
Fakultní nemocnice Brno Bohunice-Gynekologicko-porodnicka klinika ( Site 0404)
Brno, Brno-mesto, 62500, Czechia
Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 0403)
Ostrava, Moravian-Silesian Region, 708 52, Czechia
Nemocnice AGEL Novy Jicin a.s.-Oddeleni radioterapie a onkologie ( Site 0406)
Nový Jiín, Novy Jicin, 741 01, Czechia
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0402)
Olomouc, Olomouc Region, 779 00, Czechia
Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 0405)
Prague, Praha 2, 12808, Czechia
Fakultni nemocnice Bulovka-Gynekologicko-porodnicka klinika ( Site 0401)
Prague, Praha 8, 180 00, Czechia
Nemocnice Tomase Bati ve Zline-Onkologické oddělení ( Site 0407)
Zlín, Zlín, 762 75, Czechia
Fakultni nemocnice Kralovske Vinohrady-Gynekologicko-porodnická klinika ( Site 0408)
Prague, 10034, Czechia
Rigshospitalet ( Site 0903)
Copenhagen, Capital Region, 2100, Denmark
Herlev and Gentofte Hospital ( Site 0902)
Copenhagen, Capital Region, 2730, Denmark
Aalborg Universitetshospital, Syd ( Site 0905)
Aalborg, North Denmark, 9000, Denmark
Roskilde Sygehus-Oncology department ( Site 0904)
Roskilde, Region Sjælland, DK-4000, Denmark
Kuopion Yliopistollinen Sairaala ( Site 1002)
Kuopio, Northern Savonia, 70200, Finland
Tampereen yliopistollinen sairaala-Gynecology and Obstetrics ( Site 1001)
Tampere, Pirkanmaa, 33520, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1003)
Helsinki, Uusimaa, 00290, Finland
Universitaetsklinikum Ulm. ( Site 1106)
Ulm, Baden-Wurttemberg, 89081, Germany
Universitätsklinikum Bonn-Gynaecological oncology ( Site 1105)
Bonn, North Rhine-Westphalia, 53127, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur ( Site 1101)
Dresden, Saxony, 01307, Germany
Charité Campus Virchow-Klinikum ( Site 1103)
Berlin, 13353, Germany
Országos Onkológiai Intézet-Ngyógyászat ( Site 1201)
Budapest, 1122, Hungary
Bon Secours Cork Hospital ( Site 1305)
Cork, T12 DV56, Ireland
St. James's Hospital-Cancer clinical trials office ( Site 1301)
Dublin, D08 E9P6, Ireland
Soroka Medical Center ( Site 1403)
Beersheba, 8410101, Israel
Rambam Health Care Campus-Gyneco-oncology unit ( Site 1402)
Haifa, 3109601, Israel
Edith Wolfson Medical Center-Obstetrics & Gynecology ( Site 1405)
Holon, 5822012, Israel
Shaare Zedek Medical Center ( Site 1404)
Jerusalem, 9103102, Israel
Sheba Medical Center ( Site 1401)
Ramat Gan, 5265601, Israel
Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Sperimentale Uro-Genitale ( Site 1501)
Naples, Campania, 80131, Italy
IRCCS - AOU di Bologna-SSD Oncologia medica Addarii ( Site 1503)
Bologna, Emilia-Romagna, 40138, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1513)
Meldola, Emilia-Romagna, 47014, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 1507)
Milan, Lombardy, 20133, Italy
Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 1514)
Turin, Piedmont, 10128, Italy
Istituto Nazionale Tumori Regina Elena-Oncologia Medica 1 ( Site 1504)
Rome, Roma, 00144, Italy
Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1509)
Florence, Tuscany, 50134, Italy
AULSS8 Berica-Ospedale S.Bortolo-ONCOLOGIA CLINICA ( Site 1510)
Vicenza, Veneto, 36100, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 1506)
Milan, 20141, Italy
Fondazione Policlinico Universitario Agostino Gemelli-Ginecologia Oncologica ( Site 1502)
Roma, 00168, Italy
National Cancer Center Hospital East ( Site 1604)
Kashiwa, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center ( Site 1611)
Matsuyama, Ehime, 791-0280, Japan
Ehime University Hospital ( Site 1614)
Tōon, Ehime, 791-0295, Japan
Kurume University Hospital ( Site 1612)
Kurume, Fukuoka, 830-0011, Japan
Gunma Prefectural Cancer Center ( Site 1603)
Otashi, Gunma, 373-8550, Japan
Hokkaido University Hospital ( Site 1601)
Sapporo, Hokkaido, 060-8648, Japan
University of Tsukuba Hospital ( Site 1618)
Tsukuba, Ibaraki, 305-8576, Japan
Iwate Medical University Hospital ( Site 1602)
Shiwa-gun Yahaba-cho, Iwate, 028-3695, Japan
Niigata University Medical & Dental Hospital ( Site 1613)
Chuo-ku, Niigata, Niigata, 951-8520, Japan
Saitama Medical University International Medical Center ( Site 1605)
Hidaka-shi, Saitama, 350-1200, Japan
Shizuoka Cancer Center ( Site 1609)
Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777, Japan
National Cancer Center Hospital ( Site 1607)
Chuo-ku, Tokyo, 104-0045, Japan
Cancer Institute Hospital of JFCR ( Site 1616)
Koto, Tokyo, 135-8550, Japan
The Jikei University Hospital ( Site 1615)
Minato-ku, Tokyo, 105-8471, Japan
Keio University Hospital ( Site 1606)
Shinjyuku-ku, Tokyo, 160-8582, Japan
National Hospital Organization Kyushu Cancer Center ( Site 1608)
Fukuoka, 811-1395, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1617)
Osaka, 541-8567, Japan
Radboudumc-Medical Oncology ( Site 1703)
Nijmegen, Gelderland, 6525 GA, Netherlands
Maastricht UMC+ ( Site 1709)
Maastricht, Limburg, 6229 HX, Netherlands
Catharina Ziekenhuis-Oncology ( Site 1704)
Eindhoven, North Brabant, 5623 EJ, Netherlands
Amsterdam UMC, locatie AMC ( Site 1706)
Amsterdam, North Holland, 1105 AZ, Netherlands
Leids Universitair Medisch Centrum-Medical Oncology ( Site 1702)
Leiden, South Holland, 2333 ZA, Netherlands
Erasmus Medisch Centrum-Medical Oncology ( Site 1701)
Rotterdam, South Holland, 3015 GD, Netherlands
University Medical Center Groningen ( Site 1707)
Groningen, 9713 GZ, Netherlands
Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1705)
Utrecht, 3584 CX, Netherlands
Auckland City Hospital ( Site 1801)
Auckland, 1023, New Zealand
Oslo universitetssykehus, Radiumhospitalet ( Site 1901)
Oslo, 0379, Norway
Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 2004)
Poznan, Greater Poland Voivodeship, 61-848, Poland
Centrum Onkologii Ziemi Lubelskiej ( Site 2006)
Lublin, Lublin Voivodeship, 20-090, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2007)
Siedlce, Masovian Voivodeship, 08-110, Poland
Szpital Kliniczny im. Księżnej Anny Mazowieckiej ( Site 2009)
Warsaw, Masovian Voivodeship, 00-315, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Site 2008)
Warsaw, Masovian Voivodeship, 02-781, Poland
Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2003)
Bialystok, Podlaskie Voivodeship, 15-027, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 2002)
Gliwice, Silesian Voivodeship, 44-102, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2010)
Kielce, Świętokrzyskie Voivodeship, 25-734, Poland
Moscow City Oncology Hospital #62 ( Site 2204)
Krasnogorsk, Moscow Oblast, 143423, Russia
Yaroslavl Regional Cancer Hospital-Oncology ( Site 2202)
Yaroslavl, Yaroslavl Oblast, 150054, Russia
Seoul National University Hospital ( Site 2302)
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 2301)
Seoul, 03722, South Korea
Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 2303)
Seoul, 05505, South Korea
Gangnam Severance Hospital ( Site 2304)
Seoul, 06273, South Korea
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2406)
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2405)
A Coruña, La Coruna, 15006, Spain
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2402)
Madrid, Madrid, Comunidad de, 28034, Spain
COMPLEJO HOSPITALARIO DE NAVARRA ( Site 2407)
Pamplona, Navarre, 31009, Spain
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2404)
Valencia, Valenciana, Comunitat, 46009, Spain
Hospital Universitari Vall d'Hebron ( Site 2403)
Barcelona, 08035, Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2401)
Seville, 41013, Spain
Skånes Universitetssjukhus Lund-Department of Hematology ( Site 2504)
Lund, Skåne County, 22185, Sweden
Karolinska Universitetssjukhuset Solna ( Site 2502)
Stockholm, Stockholm County, 171 64, Sweden
Norrlands universitetssjukhus-Cancercentrum ( Site 2503)
Umeå, Västerbotten County, 901 85, Sweden
Taichung Veterans General Hospital ( Site 2602)
Taichung, 407, Taiwan
NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2604)
Tainan, 704, Taiwan
National Taiwan University Hospital ( Site 2603)
Taipei, 10002, Taiwan
Mackay Memorial Hospital ( Site 2601)
Taipei, 10449, Taiwan
Taipei Veterans General Hospital ( Site 2605)
Taipei, 112, Taiwan
Istanbul Universitesi Cerrahpasa ( Site 2702)
Fatih, Istanbul, 34098, Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2704)
Ankara, 06230, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2706)
Ankara, 06800, Turkey (Türkiye)
Akdeniz Universitesi Hastanesi ( Site 2701)
Antalya, 07070, Turkey (Türkiye)
Istanbul University Capa Campus-department of obstetrics and gynaecology ( Site 2705)
Istanbul, 34093, Turkey (Türkiye)
The Christie ( Site 2807)
Manchester, England, M20 4BX, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 2805)
Glasgow, Glasgow City, G12 0YN, United Kingdom
St Bartholomew's Hospital ( Site 2804)
London, London, City of, EC1A 7BE, United Kingdom
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2806)
London, London, City of, SW3 6JJ, United Kingdom
Hammersmith Hospital-Medical Oncology ( Site 2808)
London, London, City of, W12 OHS, United Kingdom
Related Publications (1)
Secord AA, Powell MA, McAlpine J. Molecular Characterization and Clinical Implications of Endometrial Cancer. Obstet Gynecol. 2025 Nov 1;146(5):660-671. doi: 10.1097/AOG.0000000000006080. Epub 2025 Sep 18.
PMID: 40966692DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2021
First Posted
December 30, 2021
Study Start
February 3, 2022
Primary Completion (Estimated)
May 27, 2027
Study Completion (Estimated)
May 27, 2027
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf