A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29)
TroFuse-033
A Phase 3 Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (TroFuse-033/GOG-3119/ENGOT-en29)
7 other identifiers
interventional
1,123
33 countries
250
Brief Summary
Researchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent.
- EC is a type of cancer that starts in the tissues inside the uterus (womb)
- pMMR indicates that certain normal proteins are present in the cancer cells
- Advanced means the cancer has spread locally or to other parts of the body (metastatic) and cannot be removed with surgery
- Recurrent means the cancer came back after surgery Sacituzumab tirumotecan (also known as sac-TMT) and pembrolizumab are the study medicines. Sac-TMT is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goal of this study is to learn if people who receive sac-TMT with pembrolizumab live longer and without the cancer getting worse compared to people who receive pembrolizumab alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2025
Longer than P75 for phase_3
250 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
April 23, 2025
CompletedFirst Posted
Study publicly available on registry
May 1, 2025
CompletedStudy Start
First participant enrolled
May 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 24, 2032
June 3, 2026
June 1, 2026
7 years
April 23, 2025
June 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maintenance Treatment: Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as evaluated by the blinded independent central review (BICR). 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 new lesions is also considered PD.
Up to approximately 44 months
Maintenance Treatment: Overall Survival (OS)
OS is defined as time from randomization to death due to any cause.
Up to approximately 54 months
Secondary Outcomes (7)
Maintenance Treatment: Progression-Free Survival 2 (PFS2) as Assessed by Investigator
Up to approximately 54 months
Maintenance Treatment: Number of Participants Who Experience One or More Adverse Events (AEs)
Up to approximately 27 months
Maintenance Treatment: Number of Participants Who Discontinue Study Intervention Due to an AE
Up to approximately 24 months
Maintenance Treatment: Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Mean Score
Baseline and up to approximately 24 months
Maintenance Treatment: Change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
Baseline and up to approximately 24 months
- +2 more secondary outcomes
Study Arms (4)
Maintenance Treatment Arm A: Pembrolizumab + Sacituzumab Tirumotecan
EXPERIMENTALDuring the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin area under the curve (AUC) 5 (mg/mL/min), and paclitaxel 175 mg/m\^2 or docetaxel 75 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). During the Maintenance Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle and pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months).
Maintenance Treatment Arm B: Pembrolizumab Monotherapy
ACTIVE COMPARATORDuring the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min), and paclitaxel 175 mg/m\^2 or docetaxel 75 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). During the Maintenance Treatment Phase, participants receive pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months).
Subsequent Treatment Arm A: Pembrolizumab + Sacituzumab Tirumotecan
EXPERIMENTALDuring the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min), and paclitaxel 175 mg/m\^2 or docetaxel 75 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). During the Subsequent Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle until discontinuation criteria is met and pembrolizumab 400 mg on Day 1 of each 6-week cycle for up to 14 cycles (up to approximately 19 months).
Subsequent Treatment Arm B: Sacituzumab Tirumotecan Monotherapy
ACTIVE COMPARATORDuring the Induction Phase, participants receive pembrolizumab 200 mg, carboplatin AUC 5 (mg/mL/min), and paclitaxel 175 mg/m\^2 or docetaxel 75 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). During the Subsequent Treatment Phase, participants receive sac-TMT 4 mg/kg on Days 1, 15, and 29 of each 6-week cycle until discontinuation criteria is met.
Interventions
Intravenous (IV) Infusion
During the Induction Phase, participants receive carboplatin AUC 5 (mg/mL/min) on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion.
IV Infusion
During the Induction Phase, participants receive paclitaxel 175 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion.
During the Induction Phase, participants may receive docetaxel (in place of paclitaxel) 75 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion.
Eligibility Criteria
You may qualify if:
- Has a histologically confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that has been confirmed as proficient mismatch repair (pMMR)
- Has radiographically evaluable disease, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator
- Has received no prior systemic therapy for endometrial carcinoma except the following conditions as pre-specified by the protocol: 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent, prior radiation with or without radiosensitizing chemotherapy if \>2 weeks before the start of induction treatment, or prior hormonal therapy for treatment of endometrial carcinoma that was discontinued ≥1 week before the start of induction treatment
You may not qualify if:
- Has carcinosarcoma, neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of sarcomas
- Has endometrial carcinoma of any histology that is mismatch repair deficient (dMMR)
- Is a candidate for debulking surgery resulting in complete removal of all tumor and no evidence of radiological disease following surgery, or curative-intent radiotherapy at the time of enrollment
- Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Human Immunodeficiency Virus-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Received prior therapy in any setting with any of the following: anti-programmed cell death 1 protein, anti-programmed cell death ligand 1, anti-programmed cell death ligand 2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor; trophoblast cell surface antigen 2-targeted antibody drug conjugate; or topoisomerase I inhibitor-containing antibody drug conjugate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (253)
University of South Alabama, Mitchell Cancer Institute ( Site 6033)
Mobile, Alabama, 36604, United States
Alaska Women's Cancer Care ( Site 6036)
Anchorage, Alaska, 99508, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 6020)
Orange, California, 92868, United States
John Muir Health Cancer Center ( Site 6028)
Walnut Creek, California, 94598, United States
Yale University School of Medicine ( Site 6009)
New Haven, Connecticut, 06510, United States
MedStar Washington Hospital Center ( Site 5005)
Washington D.C., District of Columbia, 20010, United States
Florida Cancer Specialists - South ( Site 7003)
Fort Myers, Florida, 33901, United States
UF Health Davis Cancer Pavilion and Shands Med Plaza ( Site 6026)
Gainesville, Florida, 32608, United States
Mount Sinai Braman Comprehensive Cancer Center ( Site 6031)
Miami Beach, Florida, 33140, United States
AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 6002)
Orlando, Florida, 32804, United States
Florida Cancer Specialists ( Site 7002)
St. Petersburg, Florida, 33701, United States
Florida Cancer Specialists East ( Site 7001)
West Palm Beach, Florida, 33401, United States
St. Joseph's/Candler Health System ( Site 6021)
Savannah, Georgia, 31405, United States
University of Chicago Medical Center ( Site 5002)
Chicago, Illinois, 60637, United States
Parkview Research Center ( Site 6008)
Fort Wayne, Indiana, 46845, United States
Women's Cancer Care ( Site 6010)
Covington, Louisiana, 70433, United States
TRIALS 365 ( Site 6005)
Shreveport, Louisiana, 71103, United States
Maine Medical Center - Scarborough Campus ( Site 6042)
Scarborough, Maine, 04074, United States
Tufts Medical Center ( Site 6052)
Boston, Massachusetts, 02111, United States
Minnesota Oncology Hematology, PA ( Site 8003)
Minneapolis, Minnesota, 55404, United States
St. Dominic's Hospital ( Site 5004)
Jackson, Mississippi, 39216, United States
Holy Name Medical Center ( Site 6011)
Teaneck, New Jersey, 07666, United States
University of New Mexico Comprehensive Cancer Center ( Site 6046)
Albuquerque, New Mexico, 87131, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 6055)
Mineola, New York, 11501, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6004)
New York, New York, 10016, United States
Duke Cancer Institute ( Site 6049)
Durham, North Carolina, 27710, United States
FirstHealth of the Carolinas ( Site 6037)
Pinehurst, North Carolina, 28374, United States
Miami Valley Hospital South ( Site 6014)
Centerville, Ohio, 45459, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)
Columbus, Ohio, 43210, United States
Kettering Health Main Campus-Kettering Health Cancer Center ( Site 5001)
Kettering, Ohio, 45429, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6047)
Tulsa, Oklahoma, 74146, United States
Oncology Associates of Oregon, P.C. ( Site 8005)
Eugene, Oregon, 97401, United States
St. Luke's University Health Network ( Site 6041)
Bethlehem, Pennsylvania, 18015, United States
Hospital of the University of Pennsylvania ( Site 5007)
Philadelphia, Pennsylvania, 19104, United States
Hospital of the University of Pennsylvania ( Site 6023)
Philadelphia, Pennsylvania, 19104, United States
AHN West Penn Hospital ( Site 6006)
Pittsburgh, Pennsylvania, 15224, United States
Women & Infants Hospital ( Site 5003)
Providence, Rhode Island, 02905, United States
Texas Oncology - DFW ( Site 8004)
Fort Worth, Texas, 76104, United States
Houston Methodist Hospital ( Site 6057)
Houston, Texas, 77030, United States
Texas Oncology-San Antonio Medical Center ( Site 8001)
San Antonio, Texas, 78240, United States
Texas Oncology - Northeast Texas ( Site 8002)
Tyler, Texas, 75702, United States
Texas Oncology - Gulf Coast ( Site 8006)
Webster, Texas, 77598, United States
Inova Schar Cancer Institute ( Site 6003)
Fairfax, Virginia, 22031, United States
VCU Health Adult Outpatient Pavillion ( Site 5000)
Richmond, Virginia, 23219, United States
Instituto Alexander Fleming ( Site 0105)
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0108)
Mar del Plata, Buenos Aires, B7600FZO, Argentina
Fundación Respirar ( Site 0101)
Buenos Aires, Buenos Aires F.D., C1426AAL, Argentina
Hospital Británico de Buenos Aires ( Site 0103)
CABA, C1280AEB, Argentina
Instituto San Marcos ( Site 0106)
San Juan, J5400EBB, Argentina
Blacktown Hospital ( Site 0201)
Blacktown, New South Wales, 2148, Australia
Royal Brisbane and Women's Hospital ( Site 0206)
Brisbane, Queensland, 4029, Australia
Epworth Freemasons ( Site 0207)
Melbourne, Victoria, 3002, Australia
Sir Charles Gairdner Hospital ( Site 0203)
Nedlands, Western Australia, 6009, Australia
Medizinische Universität Graz-Abteilung für Gynäkologie / Onkologie ( Site 0303)
Graz, Styria, 8036, Austria
Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 0301)
Innsbruck, Tyrol, 6020, Austria
Medizinische Universität Wien - Allg. Gynaekologie & Gyn. Onkologie ( Site 0302)
Vienna, 1090, Austria
CHU Saint-Pierre ( Site 0405)
Brussels, Bruxelles-Capitale, Region de, 1000, Belgium
AZ Maria Middelares ( Site 0402)
Ghent, Oost-Vlaanderen, 9000, Belgium
UZ Leuven ( Site 0401)
Leuven, Vlaams-Brabant, 3000, Belgium
Grand Hôpital de Charleroi ( Site 0403)
Charleroi, Wallonne, Region, 6060, Belgium
CHU de Liege ( Site 0404)
Liège, Wallonne, Region, 4000, Belgium
Hospital Araújo Jorge ( Site 0521)
Goiânia, Goiás, 74605-070, Brazil
Liga Norte Riograndense Contra o Câncer ( Site 0523)
Natal, Rio Grande do Norte, 59062-000, Brazil
Hospital São Lucas da PUCRS ( Site 0522)
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0525)
São Paulo, São Paulo, 04014-002, Brazil
Instituto Nacional de Câncer - INCA ( Site 0515)
Rio de Janeiro, 20220-410, Brazil
BC Cancer Surrey ( Site 0621)
Surrey, British Columbia, V3V 1Z2, Canada
CancerCare Manitoba ( Site 0617)
Winnipeg, Manitoba, R3E 0V9, Canada
NL Health Services ( Site 0602)
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Royal Victoria Regional Health Centre ( Site 0615)
Barrie, Ontario, L4M 6M2, Canada
Sault Area Hospital ( Site 0616)
Sault Ste. Marie, Ontario, P6B 0A8, Canada
Sunnybrook Research Institute ( Site 0610)
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Center ( Site 0609)
Toronto, Ontario, M5G 2M9, Canada
Windsor Regional Cancer Program ( Site 0614)
Windsor, Ontario, N8W 1L9, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0605)
Montreal, Quebec, H2X 0C1, Canada
Jewish General Hospital ( Site 0606)
Montreal, Quebec, H3T 1E2, Canada
McGill University Health Centre ( Site 0604)
Montreal, Quebec, H4A 3J1, Canada
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0608)
Sherbrooke, Quebec, J1H 5N4, Canada
Centro de Estudios Clínicos SAGA ( Site 0708)
Santiago, Region M. de Santiago, 7500653, Chile
FALP ( Site 0702)
Santiago, Region M. de Santiago, 7500921, Chile
Pontificia Universidad Catolica de Chile ( Site 0705)
Santiago, Region M. de Santiago, 8330032, Chile
Bradfordhill ( Site 0703)
Santiago, Region M. de Santiago, 8420383, Chile
ONCOCENTRO APYS ( Site 0704)
Viña del Mar, Valparaiso, 2520598, Chile
Anhui Provincial Hospital ( Site 0830)
Hefei, Anhui, 230001, China
Peking University Peoples Hospital ( Site 0845)
Beijing, Beijing Municipality, 100044, China
Chongqing University Cancer Hospital ( Site 0838)
Chongqing, Chongqing Municipality, 400030, China
Fujian Province Cancer Hospital ( Site 0802)
Fuzhou, Fujian, 350014, China
The First Affiliated hospital of Xiamen University ( Site 0822)
Xiamen, Fujian, 361003, China
Sun Yat-sen University Cancer Center ( Site 0846)
Guangzhou, Guangdong, 510060, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 0801)
Guangzhou, Guangdong, 510220, China
Zhujiang Hospital of Southern Medical University ( Site 0829)
Guangzhou, Guangdong, 510280, China
Cancer Hospital of Shantou University Medical College ( Site 0827)
Shantou, Guangdong, 515041, China
Affiliated Hospital of Guangdong Medical University ( Site 0823)
Zhanjiang, Guangdong, 524004, China
Liuzhou People's Hospital ( Site 0831)
Liuzhou, Guangxi, 545006, China
Guangxi Medical University Affiliated Tumor Hospital. ( Site 0825)
Nanning, Guangxi, 530021, China
Harbin Medical University Cancer Hospital ( Site 0850)
Harbin, Heilongjiang, 101149, China
Henan Cancer Hospital ( Site 0806)
Zhengzhou, Henan, 450008, China
The Second Affiliated Hospital of Zhengzhou University ( Site 0833)
Zhengzhou, Henan, 450014, China
Wuhan Union Hospital Cancer Center ( Site 0824)
Wuhan, Hubei, 430023, China
Xiangya Hospital Central South University ( Site 0821)
Changsha, Hunan, 410008, China
Hunan Cancer Hospital ( Site 0826)
Changsha, Hunan, 410013, China
Nanjing First Hospital ( Site 0828)
Nanjing, Jiangsu, 210006, China
Jiangxi Maternal and Child Health Hospital ( Site 0807)
Nanchang, Jiangxi, 337000, China
The First Hospital Of Jilin University ( Site 0815)
Changchun, Jilin, 134021, China
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 0816)
Xi'an, Shaanxi, 710061, China
Shandong Cancer Hospital ( Site 0803)
Jinan, Shandong, 250117, China
Shanghai Tenth People's Hospital ( Site 0847)
Shanghai, Shanghai Municipality, 200072, China
Obstetrics & Gynecology Hospital of Fudan University ( Site 0818)
Shanghai, Shanghai Municipality, 200090, China
Shanxi Provincial Cancer Hospital ( Site 0843)
Taiyuan, Shanxi, 030013, China
West China Second University Hospital, Sichuan University ( Site 0849)
Chengdu, Sichuan, 610000, China
The Second People's Hospital of Yibin ( Site 0840)
Yibin, Sichuan, 644000, China
Yunnan Province Cancer Hospital ( Site 0811)
Kunming, Yunnan, 650118, China
The Affiliated Women's Hospital of Zhejiang University ( Site 0834)
Hangzhou, Zhejiang, 310006, China
Taizhou Hospital of Zhejiang Province ( Site 0809)
Linhai, Zhejiang, 317000, China
The First Affiliated Hospital of Wenzhou Medical University ( Site 0805)
Wenzhou, Zhejiang, 325015, China
Instituto de Cancerología S.A.S ( Site 0904)
Medellín, Antioquia, 050025, Colombia
Fundacion Colombiana de Cancerología Clinica Vida ( Site 0905)
Medellín, Antioquia, 050030, Colombia
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0902)
Bogotá, Bogota D.C., 110131, Colombia
Oncologos Del Occidente ( Site 0907)
Pereira, Risaralda Department, 660001, Colombia
Fakultni nemocnice Ostrava ( Site 1104)
Ostrava, Ostrava Mesto, 708 52, Czechia
Nemocnice AGEL Novy Jicin a.s. ( Site 1102)
Nový Jičín, 741 01, Czechia
Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 1101)
Prague, 128 08, Czechia
Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 1103)
Prague, 150 06, Czechia
Herlev and Gentofte Hospital ( Site 1202)
Copenhagen, Capital Region, 2730, Denmark
Aarhus Universitetshospital, Skejby ( Site 1205)
Aarhus, Central Jutland, 8200, Denmark
Aalborg Universitetshospital, Syd ( Site 1203)
Aalborg, North Denmark, 9000, Denmark
Roskilde Sygehus ( Site 1204)
Roskilde, Region Sjælland, 4000, Denmark
Kuopion Yliopistollinen Sairaala ( Site 1304)
Kuopio, Northern Savonia, 70029, Finland
Tampereen yliopistollinen sairaala ( Site 1303)
Tampere, Pirkanmaa, 33520, Finland
Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1302)
Turku, Southwest Finland, 20520, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1301)
Helsinki, Uusimaa, 00029, Finland
Institut Paoli Calmettes ( Site 1410)
Marseille, Bouches-du-Rhone, 13272, France
Centre Francois Baclesse ( Site 1412)
Caen, Calvados, 14000, France
Hôpital Privé Des Côtes d'Armor ( Site 1404)
Plérin, Cotes-d Armor, 22190, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1405)
Bordeaux, Gironde, 33076, France
Oncopole Claudius Regaud ( Site 1407)
Toulouse, Haute-Garonne, 31059, France
Institut Curie - site Saint-Cloud ( Site 1408)
Saint-Cloud, Hauts-de-Seine, 92210, France
Institut De Cancerologie De L Ouest ( Site 1403)
Saint-Herblain, Loire-Atlantique, 44800, France
CENTRE LEON BERARD ( Site 1401)
Lyon, Rhone, 69008, France
Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 1409)
Paris, 75020, France
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1411)
Paris, 75679, France
Klinikum Mutterhaus der Borromäerinnen ( Site 1506)
Trier, Rhineland-Palatinate, 54290, Germany
CaritasKlinikum Saarbruecken St. Theresia ( Site 1508)
Saarbrücken, Saarland, 66113, Germany
Universitaetsklinikum Leipzig ( Site 1505)
Leipzig, Saxony, 04103, Germany
Universitaetsklinikum Jena ( Site 1503)
Jena, Thuringia, 07747, Germany
Charité Campus Virchow-Klinikum ( Site 1501)
Berlin, 13353, Germany
Asklepios Kliniken Hamburg ( Site 1509)
Hamburg, 22307, Germany
Alexandra General Hospital of Athens ( Site 1604)
Athens, Attica, 115 28, Greece
Aretaieio Hospital ( Site 1602)
Athens, Attica, 115 28, Greece
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1603)
Chaïdári, Attica, 124 62, Greece
Iaso Genera ( Site 1605)
Marousi, Attica, 151 23, Greece
Agios Loukas Clinic-DEPARTMENT OF ONCOLOGY ( Site 1601)
Thessaloniki, Central Macedonia, 552 36, Greece
Semmelweis Egyetem Szuleszeti es Nogyogyaszati Klinika ( Site 1703)
Budapest, 1088, Hungary
Országos Onkológiai Intézet-Ngyógyászat ( Site 1702)
Budapest, 1122, Hungary
Debreceni Egyetem Klinikai Kozpont-Szülészeti és Nőgyógyászati Klinika ( Site 1701)
Debrecen, 4032, Hungary
Cork University Hospital ( Site 1903)
Cork, T12 DC4A, Ireland
Mater Misericordiae University Hospital ( Site 1904)
Dublin, D07 R2WY, Ireland
St. James's Hospital ( Site 1901)
Dublin, D08 E9P6, Ireland
Rambam Health Care Campus ( Site 2025)
Haifa, 3109601, Israel
Carmel Hospital ( Site 2023)
Haifa, 3436212, Israel
Shaare Zedek Medical Center ( Site 2020)
Jerusalem, 9103102, Israel
Meir Medical Center. ( Site 2021)
Kfar Saba, 4428164, Israel
Sourasky Medical Center ( Site 2022)
Tel Aviv, 6423906, Israel
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 2107)
Meldola, Forli-Cesena, 47014, Italy
Ospedale Humanitas San Pio X ( Site 2106)
Milan, Lombardy, 20159, Italy
Ospedale Cannizzaro ( Site 2103)
Catania, 95126, Italy
Azienda Ospedaliera Universitaria Careggi ( Site 2109)
Florence, 50134, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 2114)
Milan, 20133, Italy
Istituto Europeo di Oncologia ( Site 2110)
Milan, 20141, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2104)
Naples, 80131, Italy
Azienda Ospedaliero Universitaria Pisana Ospedale S. Chiara ( Site 2108)
Pisa, 56126, Italy
Istituto Nazionale Tumori Regina Elena ( Site 2102)
Roma, 00 128, Italy
Fondazione Policlinico Universitario Agostino Gemelli ( Site 2105)
Roma, 00168, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 2111)
Torino, 10126, Italy
Ospedale Mauriziano ( Site 2101)
Torino, 10128, Italy
Ospedale Santa Maria di Ca' Foncello ( Site 2112)
Treviso, 31100, Italy
Aichi Cancer Center ( Site 2217)
Nagoya, Aichi-ken, 464-8681, Japan
National Hospital Organization Shikoku Cancer Center ( Site 2206)
Matsuyama, Ehime, 791-0280, Japan
Ehime University Hospital ( Site 2213)
Tōon, Ehime, 791-0295, Japan
Kurume University Hospital ( Site 2204)
Kurume, Fukuoka, 830-0011, Japan
Gunma Prefectural Cancer Center ( Site 2202)
Ōta, Gunma, 373-8550, Japan
National Hospital Organization Hokkaido Cancer Center ( Site 2212)
Sapporo, Hokkaido, 003-0804, Japan
Hyogo Cancer Center ( Site 2216)
Akashi, Hyōgo, 673-8558, Japan
Iwate Medical University Hospital ( Site 2207)
Shiwa-gun, Iwate, 028-3695, Japan
Saitama Medical University International Medical Center ( Site 2201)
Hidaka, Saitama, 350-1298, Japan
Shizuoka Cancer Center ( Site 2205)
Sunto-gun, Shizuoka, 411-8777, Japan
National Cancer Center Hospital ( Site 2211)
Chūō, Tokyo, 104-0045, Japan
Cancer Institute Hospital of JFCR ( Site 2208)
Koto, Tokyo, 135-8550, Japan
Keio University Hospital ( Site 2209)
Shinjuku, Tokyo, 160-8582, Japan
National Hospital Organization Kyushu Cancer Center ( Site 2203)
Fukuoka, 811-1395, Japan
Fukushima Medical University Hospital ( Site 2218)
Fukushima, 960-1295, Japan
Niigata Cancer Center Hospital ( Site 2210)
Niigata, 951-8566, Japan
Okayama University Hospital ( Site 2215)
Okayama, 700-8558, Japan
Yamagata University Hospital ( Site 2219)
Yamagata, 990-9585, Japan
CIO - Centro de Inmuno-Oncología de Occidente ( Site 2402)
Guadalajara, Jalisco, 44630, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 2401)
Monterrey, Nuevo León, 64460, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 2404)
Oaxaca City, Oaxaca, 68020, Mexico
Centro de Investigación Oncológica Galerías SC ( Site 2405)
Aguascalientes, 20124, Mexico
Sitio Clínico UIS Chihuahua (Operadora Unidad de Investigación en Salud de Chihuahua SA de CV) ( Site 2406)
Chihuahua City, 31203, Mexico
Maastricht UMC+ ( Site 2501)
Maastricht, Limburg, 6229 HX, Netherlands
Universitair Medisch Centrum Utrecht ( Site 2503)
Utrecht, 3584 CX, Netherlands
Stavanger Universitetssykehus ( Site 2703)
Norway, Rogaland, 4011, Norway
Universitetssykehuset Nord-Norge HF ( Site 2702)
Tromsø, Troms, 9038, Norway
Oslo universitetssykehus, Radiumhospitalet ( Site 2701)
Oslo, 0379, Norway
Clínica San Felipe ( Site 2804)
Jesus Maria, Lima region, 15072, Peru
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 2803)
San Isidro, Lima region, 15038, Peru
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 2805)
Lima, 15038, Peru
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 3011)
Poznan, Greater Poland Voivodeship, 60-569, Poland
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 3003)
Poznan, Greater Poland Voivodeship, 61-866, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 3004)
Siedlce, Masovian Voivodeship, 08-110, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 3002)
Warsaw, Masovian Voivodeship, 02-781, Poland
Bialostockie Centrum Onkologii ( Site 3007)
Bialystok, Podlaskie Voivodeship, 15-027, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi ( Site 3001)
Gdansk, Pomeranian Voivodeship, 80-214, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 3006)
Gliwice, Silesian Voivodeship, 44-101, Poland
Swietokrzyskie Centrum Onkologii. ( Site 3008)
Kielce, Świętokrzyskie Voivodeship, 25-734, Poland
Puerto Rico Cancer Specialists Clinical Trials ( Site 4201)
San Juan, 00917, Puerto Rico
National University Hospital ( Site 3202)
Singapore, Central Singapore, 119074, Singapore
National Cancer Centre Singapore ( Site 3201)
Singapore, Central Singapore, 168583, Singapore
National Cancer Center ( Site 3106)
Gyeonggi-do, Kyonggi-do, 10408, South Korea
Keimyung University Dongsan Hospital ( Site 3105)
Daegu, Taegu-Kwangyokshi, 42601, South Korea
Seoul National University Hospital ( Site 3102)
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System ( Site 3101)
Seoul, 03722, South Korea
Asan Medical Center ( Site 3103)
Seoul, 05505, South Korea
Samsung Medical Center ( Site 3104)
Seoul, 06351, South Korea
Institut Català d'Oncologia - L'Hospitalet ( Site 3408)
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Institut Català d'Oncologia (ICO) - Girona ( Site 3407)
Girona, Gerona, 17007, Spain
Hospital Universitari Vall d''Hebron ( Site 3401)
Barcelona, 08035, Spain
Hospital Universitario Reina Sofia ( Site 3402)
Córdoba, 14004, Spain
Hospital Universitario Ramon y Cajal ( Site 3403)
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre ( Site 3404)
Madrid, 28041, Spain
Hospital Universitario La Paz ( Site 3406)
Madrid, 28046, Spain
Fundación Instituto Valenciano de Oncología ( Site 3405)
Valencia, 46009, Spain
Skånes Universitetssjukhus Lund ( Site 3502)
Lund, Skåne County, 22185, Sweden
Akademiska Sjukhuset ( Site 3501)
Uppsala, Uppsala County, 751 85, Sweden
Taichung Veterans General Hospital ( Site 3703)
Taichung, 40705, Taiwan
National Cheng Kung University Hospital ( Site 3702)
Tainan, 704, Taiwan
National Taiwan University Hospital ( Site 3701)
Taipei, 10002, Taiwan
Mackay Memorial Hospital ( Site 3704)
Taipei, 10449, Taiwan
Linkou Chang Gung Memorial Hospital ( Site 3705)
Taoyuan, 333, Taiwan
Ramathibodi Hospital. ( Site 3802)
Bangkok, Bangkok, 10400, Thailand
Faculty of Medicine Siriraj Hospital ( Site 3801)
Bangkok, Bangkok, 10700, Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 3804)
Chiang Mai, 50200, Thailand
Faculty of Medicine - Khon Kaen University ( Site 3803)
Khon Kaen, 40002, Thailand
University Hospitals Sussex NHS Foundation Trust ( Site 4011)
East Sussex, Brighton And Hove, BN2 1ES, United Kingdom
Addenbrookes Hospital ( Site 4002)
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
University College London Hospital ( Site 4001)
London, London, City of, NW1 2PG, United Kingdom
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 4006)
London, London, City of, SW3 6JJ, United Kingdom
Hammersmith Hospital ( Site 4010)
London, London, City of, W12 0HS, United Kingdom
Western General Hospital ( Site 4012)
Edinburgh, Midlothian, EH4 2XU, United Kingdom
Royal Marsden Hospital (Sutton) ( Site 4005)
London, Surrey, SM3 5PT, United Kingdom
Leicester Royal Infirmary ( Site 4008)
Leicester, LE1 5WW, United Kingdom
Maidstone Hospital ( Site 4007)
Maidstone, ME16 9QQ, United Kingdom
The Christie NHS Foundation Trust ( Site 4003)
Manchester, M20 4BX, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2025
First Posted
May 1, 2025
Study Start
May 21, 2025
Primary Completion (Estimated)
May 24, 2032
Study Completion (Estimated)
May 24, 2032
Last Updated
June 3, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf