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A Study of Sacituzumab Tirumotecan and Pembrolizumab for Endometrial Cancer

This study is looking for new ways to treat advanced or recurrent endometrial cancer (cancer that starts in the uterus) that has a specific biomarker called proficient mismatch repair (pMMR). Researchers are comparing a combination of sacituzumab tirumotecan and pembrolizumab to pembrolizumab alone. Sacituzumab tirumotecan is an antibody drug conjugate (ADC), which means it's designed to deliver treatment directly to cancer cells. Pembrolizumab is an immunotherapy. You would first receive a combination of pembrolizumab, carboplatin, and paclitaxel (or docetaxel). If your cancer doesn't worsen, you would then be randomly assigned to receive either sacituzumab tirumotecan with pembrolizumab or pembrolizumab alone. The study aims to see if the combination treatment can help you live longer without your cancer getting worse (progression-free survival) and improve overall survival. The study plans to enroll 1123 women aged 18 and older with pMMR endometrial cancer.

Study design
This is an interventional study planning to enroll 1123 participants. After an initial treatment phase, participants are randomly assigned to different treatment groups.
What's involved
You would receive intravenous (IV) infusions of study medications over several cycles, each lasting three weeks, for up to approximately 4 months in the initial phase. The study involves multiple treatment phases.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for progression-free survival for up to approximately 44 months and for overall survival for up to approximately 54 months.

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NCT06952504

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)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~1,123 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:PembrolizumabCarboplatinPaclitaxelDocetaxelSacituzumab TirumotecanCisplatin

At a glance

Recruiting sites
259 of 262 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maintenance Treatment: Progression-Free Survival (PFS)
Measured over Up to approximately 44 months
+1 more outcome measured

Conditions

Endometrial Cancer

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Endometrial CarcinomaMRC1 wt Allele

Where it's being run

262 sites across 157 states
Italy11
Florida6
Ontario6
Spain6
Texas5
Quebec5
Guangdong5
Israel5

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Maintenance Treatment: Progression-Free Survival (PFS)Up to approximately 44 months

    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.

  • Maintenance Treatment: Overall Survival (OS)Up to approximately 54 months

    OS is defined as time from randomization to death due to any cause.