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Sacituzumab tirumotecan plus pembrolizumab versus pembrolizumab alone for pMMR endometrial cancer

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)

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT06952504

This trial tests whether adding sacituzumab tirumotecan to pembrolizumab helps people with advanced or recurrent mismatch repair–proficient endometrial cancer live longer without their cancer getting worse compared to pembrolizumab alone.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1123 (estimated)
Ages18 Years and up
SexFemale
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionschemotherapy, radiation, Sacituzumab, pembrolizumab
Locations248 sites (Mobile, Alabama and 247 other locations)
Trial IDNCT06952504 on ClinicalTrials.gov

What this trial studies

All participants receive an initial induction phase of six three-week cycles of pembrolizumab combined with carboplatin plus paclitaxel or docetaxel. Participants whose disease does not progress after induction enter a maintenance phase and are randomly assigned to pembrolizumab with sacituzumab tirumotecan or pembrolizumab alone. Participants whose disease progresses may enter a subsequent treatment phase and be randomized to pembrolizumab plus sacituzumab tirumotecan or sacituzumab tirumotecan alone. The main goal is to compare length of time without disease progression and overall survival between the randomized groups.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed advanced or recurrent endometrial carcinoma that is mismatch repair–proficient, with radiographically evaluable disease and limited or no prior systemic therapy as allowed by the protocol.

Not a fit: Patients with mismatch repair–deficient disease, those unable to receive platinum chemotherapy or PD-1 blockade, or those who do not meet the trial's prior-therapy criteria are unlikely to be eligible or benefit from this specific trial.

Why it matters

Potential benefit: If successful, the combination could extend the time patients live without progression and possibly improve overall survival by delivering targeted chemotherapy alongside immune therapy.

How similar studies have performed: Combining antibody–drug conjugates with PD-1 inhibitors has shown promising early-phase signals in other tumor types, but this specific sacituzumab tirumotecan plus pembrolizumab approach in pMMR endometrial cancer is largely untested in late-phase trials.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Mobile, Alabama and 247 other locations

+198 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Endometrial CancerProgrammed Cell Death-1Programmed Cell Death 1 Ligand 1Programmed Cell Death 1 Ligand 2Trophoblast cell surface antigen 2
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.