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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)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: 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)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1123
Start Date
2025-05-22
Completion Date
2032-05-24
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab
Intravenous (IV) Infusion
Carboplatin
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.
Paclitaxel
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.
Docetaxel
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.
Sacituzumab Tirumotecan
IV Infusion
Cisplatin
During the Induction Phase, participants may receive cisplatin (in place of carboplatin) 75 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion
Locations (268)
University of South Alabama, Mitchell Cancer Institute ( Site 6033)
Mobile, Alabama, United States
Alaska Women's Cancer Care ( Site 6036)
Anchorage, Alaska, United States
CHAO Family Comprehensive Cancer Center and Ambulatory Care ( Site 5014)
Irvine, California, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 6020)
Orange, California, United States
Sansum Clinic (Ridley Tree) ( Site 8007)
Solvang, California, United States
John Muir Health Cancer Center ( Site 6028)
Walnut Creek, California, United States
Yale University School of Medicine ( Site 6009)
New Haven, Connecticut, United States
MedStar Washington Hospital Center ( Site 5005)
Washington D.C., District of Columbia, United States
Florida Cancer Specialists - South ( Site 7003)
Fort Myers, Florida, United States
UF Health Davis Cancer Pavilion and Shands Med Plaza ( Site 6026)
Gainesville, Florida, United States
Mount Sinai Braman Comprehensive Cancer Center ( Site 6031)
Miami Beach, Florida, United States
AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 6002)
Orlando, Florida, United States
Florida Cancer Specialists ( Site 7002)
St. Petersburg, Florida, United States
Florida Cancer Specialists East ( Site 7001)
West Palm Beach, Florida, United States
St. Joseph's/Candler Health System ( Site 6021)
Savannah, Georgia, United States
University of Chicago Medical Center ( Site 5002)
Chicago, Illinois, United States
Parkview Research Center ( Site 6008)
Fort Wayne, Indiana, United States
Women's Cancer Care ( Site 6010)
Covington, Louisiana, United States
TRIALS 365 ( Site 6005)
Shreveport, Louisiana, United States
Maine Medical Center - Scarborough Campus ( Site 6042)
Scarborough, Maine, United States
Tufts Medical Center ( Site 6052)
Boston, Massachusetts, United States
Minnesota Oncology Hematology, PA ( Site 8003)
Minneapolis, Minnesota, United States
St. Dominic's Hospital ( Site 5004)
Jackson, Mississippi, United States
Washington University - School of Medicine ( Site 5006)
St Louis, Missouri, United States
The Center of Hope ( Site 5018)
Reno, Nevada, United States
Holy Name Medical Center ( Site 6011)
Teaneck, New Jersey, United States
University of New Mexico Comprehensive Cancer Center ( Site 6046)
Albuquerque, New Mexico, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 6055)
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6004)
New York, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 6053)
New York, New York, United States
Duke Cancer Institute ( Site 6049)
Durham, North Carolina, United States
FirstHealth of the Carolinas ( Site 6037)
Pinehurst, North Carolina, United States
Miami Valley Hospital South ( Site 6014)
Centerville, Ohio, United States
University of Cincinnati Medical Center ( Site 5013)
Cincinnati, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)
Columbus, Ohio, United States
Kettering Health Main Campus-Kettering Health Cancer Center ( Site 5001)
Kettering, Ohio, United States
University of Oklahoma Health Sciences Center, Stephenson Cancer Center ( Site 6012)
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6047)
Tulsa, Oklahoma, United States
Oncology Associates of Oregon, P.C. ( Site 8005)
Eugene, Oregon, United States
St. Luke's University Health Network ( Site 6041)
Bethlehem, Pennsylvania, United States
Hospital of the University of Pennsylvania ( Site 5007)
Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania ( Site 6023)
Philadelphia, Pennsylvania, United States
AHN West Penn Hospital ( Site 6006)
Pittsburgh, Pennsylvania, United States
Women & Infants Hospital ( Site 5003)
Providence, Rhode Island, United States
Erlanger Medical Center ( Site 5009)
Chattanooga, Tennessee, United States
Texas Oncology - DFW ( Site 8004)
Fort Worth, Texas, United States
Houston Methodist Hospital ( Site 6057)
Houston, Texas, United States
Texas Oncology-San Antonio Medical Center ( Site 8001)
San Antonio, Texas, United States
Texas Oncology - Northeast Texas ( Site 8002)
Tyler, Texas, United States
Texas Oncology - Gulf Coast ( Site 8006)
Webster, Texas, United States
Inova Schar Cancer Institute ( Site 6003)
Fairfax, Virginia, United States
Virginia Cancer Specialists (VCS) ( Site 8008)
Fairfax, Virginia, United States
VCU Health Adult Outpatient Pavillion ( Site 5000)
Richmond, Virginia, United States
Instituto Alexander Fleming ( Site 0105)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0108)
Mar del Plata, Buenos Aires, Argentina
Fundación Respirar ( Site 0101)
Buenos Aires, Buenos Aires F.D., Argentina
Hospital Británico de Buenos Aires ( Site 0103)
CABA, Argentina
Instituto San Marcos ( Site 0106)
San Juan, Argentina
Blacktown Hospital ( Site 0201)
Blacktown, New South Wales, Australia
Royal Brisbane and Women's Hospital ( Site 0206)
Brisbane, Queensland, Australia
Epworth Freemasons ( Site 0207)
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital ( Site 0203)
Nedlands, Western Australia, Australia
Medizinische Universität Graz-Abteilung für Gynäkologie / Onkologie ( Site 0303)
Graz, Styria, Austria
Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 0301)
Innsbruck, Tyrol, Austria
Medizinische Universität Wien - Allg. Gynaekologie & Gyn. Onkologie ( Site 0302)
Vienna, Austria
CHU Saint-Pierre ( Site 0405)
Brussels, Bruxelles-Capitale, Region de, Belgium
AZ Maria Middelares ( Site 0402)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0401)
Leuven, Vlaams-Brabant, Belgium
Grand Hôpital de Charleroi ( Site 0403)
Charleroi, Wallonne, Region, Belgium
CHU de Liege ( Site 0404)
Liège, Wallonne, Region, Belgium
Hospital Araújo Jorge ( Site 0521)
Goiânia, Goiás, Brazil
Liga Norte Riograndense Contra o Câncer ( Site 0523)
Natal, Rio Grande do Norte, Brazil
Hospital São Lucas da PUCRS ( Site 0522)
Porto Alegre, Rio Grande do Sul, Brazil
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0525)
São Paulo, São Paulo, Brazil
Instituto Nacional de Câncer - INCA ( Site 0515)
Rio de Janeiro, Brazil
BC Cancer Surrey ( Site 0621)
Surrey, British Columbia, Canada
CancerCare Manitoba ( Site 0617)
Winnipeg, Manitoba, Canada
NL Health Services ( Site 0602)
St. John's, Newfoundland and Labrador, Canada
Royal Victoria Regional Health Centre ( Site 0615)
Barrie, Ontario, Canada
London Health Sciences Centre ( Site 0611)
London, Ontario, Canada
Sault Area Hospital ( Site 0616)
Sault Ste. Marie, Ontario, Canada
Sunnybrook Research Institute ( Site 0610)
Toronto, Ontario, Canada
Princess Margaret Cancer Center ( Site 0609)
Toronto, Ontario, Canada
Windsor Regional Cancer Program ( Site 0614)
Windsor, Ontario, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0607)
Montreal, Quebec, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0605)
Montreal, Quebec, Canada
Jewish General Hospital ( Site 0606)
Montreal, Quebec, Canada
McGill University Health Centre ( Site 0604)
Montreal, Quebec, Canada
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0608)
Sherbrooke, Quebec, Canada
Centro de Estudios Clínicos SAGA ( Site 0708)
Santiago, Region M. de Santiago, Chile
Fundación Arturo López Pérez ( Site 0702)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 0705)
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 0703)
Santiago, Region M. de Santiago, Chile
ONCOCENTRO APYS ( Site 0704)
Viña del Mar, Valparaiso, Chile
Anhui Provincial Hospital ( Site 0830)
Hefei, Anhui, China
Peking University Peoples Hospital ( Site 0845)
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital ( Site 0838)
Chongqing, Chongqing Municipality, China
Fujian Province Cancer Hospital ( Site 0802)
Fuzhou, Fujian, China
The First Affiliated hospital of Xiamen University ( Site 0822)
Xiamen, Fujian, China
Sun Yat-sen University Cancer Center ( Site 0846)
Guangzhou, Guangdong, China