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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)

RecruitingPhase 3

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)

Who can join

Ages 18 and older · Women

Full eligibility criteria
Key inclusion criteria include but are not limited to:

* 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

Key exclusion criteria include but are not limited to:

* 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

About the study

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.

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 1,123 · Started: May 22, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06952504

Locations in the U.S.

AlabamaUniversity of South Alabama, Mitchell Cancer Institute ( Site 6033), Mobile
AlaskaAlaska Women's Cancer Care ( Site 6036), Anchorage
CaliforniaCHAO Family Comprehensive Cancer Center and Ambulatory Care ( Site 5014), Irvine
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 6020), Orange
Sansum Clinic (Ridley Tree) ( Site 8007), Solvang
John Muir Health Cancer Center ( Site 6028), Walnut Creek
ConnecticutYale University School of Medicine ( Site 6009), New Haven
District of ColumbiaMedStar Washington Hospital Center ( Site 5005), Washington D.C.
FloridaFlorida Cancer Specialists - South ( Site 7003), Fort Myers
UF Health Davis Cancer Pavilion and Shands Med Plaza ( Site 6026), Gainesville
Mount Sinai Braman Comprehensive Cancer Center ( Site 6031), Miami Beach
AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 6002), Orlando
Florida Cancer Specialists ( Site 7002), St. Petersburg
Florida Cancer Specialists East ( Site 7001), West Palm Beach
GeorgiaSt. Joseph's/Candler Health System ( Site 6021), Savannah
IllinoisUniversity of Chicago Medical Center ( Site 5002), Chicago
IndianaParkview Research Center ( Site 6008), Fort Wayne
LouisianaWomen's Cancer Care ( Site 6010), Covington
TRIALS 365 ( Site 6005), Shreveport
MaineMaine Medical Center - Scarborough Campus ( Site 6042), Scarborough
MassachusettsTufts Medical Center ( Site 6052), Boston
MinnesotaMinnesota Oncology Hematology, PA ( Site 8003), Minneapolis
MississippiSt. Dominic's Hospital ( Site 5004), Jackson
New JerseyHoly Name Medical Center ( Site 6011), Teaneck
New MexicoUniversity of New Mexico Comprehensive Cancer Center ( Site 6046), Albuquerque
New YorkPerlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 6055), Mineola
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6004), New York
Memorial Sloan Kettering Cancer Center ( Site 6053), New York
North CarolinaDuke Cancer Institute ( Site 6049), Durham
FirstHealth of the Carolinas ( Site 6037), Pinehurst
OhioMiami Valley Hospital South ( Site 6014), Centerville
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007), Columbus
Kettering Health Main Campus-Kettering Health Cancer Center ( Site 5001), Kettering
OklahomaOklahoma Cancer Specialists and Research Institute, LLC ( Site 6047), Tulsa
OregonOncology Associates of Oregon, P.C. ( Site 8005), Eugene
PennsylvaniaSt. Luke's University Health Network ( Site 6041), Bethlehem
Hospital of the University of Pennsylvania ( Site 5007), Philadelphia
AHN West Penn Hospital ( Site 6006), Pittsburgh
Rhode IslandWomen & Infants Hospital ( Site 5003), Providence
TennesseeErlanger Medical Center ( Site 5009), Chattanooga
TexasTexas Oncology - DFW ( Site 8004), Fort Worth
Houston Methodist Hospital ( Site 6057), Houston
Texas Oncology-San Antonio Medical Center ( Site 8001), San Antonio
Texas Oncology - Northeast Texas ( Site 8002), Tyler
Texas Oncology - Gulf Coast ( Site 8006), Webster
VirginiaInova Schar Cancer Institute ( Site 6003), Fairfax
Virginia Cancer Specialists (VCS) ( Site 8008), Fairfax
VCU Health Adult Outpatient Pavillion ( Site 5000), Richmond

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.