Actively Recruiting
A Phase 3 Study Comparing Sacituzumab Tirumotecan with Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Mismatch Repair Proficient Endometrial Cancer
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-03
1123
Participants Needed
253
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying new treatment options for people with proficient mismatch repair pMMR endometrial cancer that is either advanced or has returned after surgery. This type of cancer starts in the lining of the uterus and pMMR means the cancer cells have certain normal proteins. The study aims to see if combining sacituzumab tirumotecan sac-TMT with pembrolizumab helps people live longer without their cancer worsening compared to pembrolizumab alone. Participants begin with an Induction Phase where they receive pembrolizumab along with carboplatin and either paclitaxel or docetaxel every three weeks for six cycles about 4 months. After this, if the cancer does not progress, participants enter the Maintenance Treatment Phase and are randomly assigned to receive pembrolizumab plus sac-TMT or pembrolizumab alone every six weeks for up to 14 cycles about 19 months. Those whose cancer progresses may enter a Subsequent Treatment Phase and receive either pembrolizumab plus sac-TMT or sac-TMT alone on a similar schedule. Throughout the study, participants will have regular assessments including scans to measure cancer progression, evaluations of overall health, and questionnaires about quality of life. Researchers will track how long participants live without cancer worsening and overall survival for up to approximately 44 to 54 months. Safety and side effects will also be monitored closely during the treatment phases. Total participation may last several years depending on individual treatment and response.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older
- Histologically confirmed diagnosis of primary advanced or recurrent endometrial carcinoma with proficient mismatch repair (pMMR)
- Radiographically evaluable disease, including measurable Stage III or measurable/non-measurable Stage IV or recurrent disease per RECIST 1.1
- No prior systemic therapy for endometrial carcinoma except 1 prior line of systemic platinum-based chemotherapy given with curative intent, prior radiation if more than 2 weeks before induction, or prior hormonal therapy discontinued at least 1 week before induction
You will not qualify if you...
- Diagnosis of carcinosarcoma, neuroendocrine tumors, endometrial sarcoma, stromal sarcoma, leiomyosarcoma, adenosarcoma, or other sarcomas
- Endometrial carcinoma that is mismatch repair deficient (dMMR)
- Candidate for debulking surgery with complete tumor removal or curative-intent radiotherapy at enrollment
- History of severe dry eye syndrome, severe Meibomian gland disease, blepharitis, or severe corneal disease delaying healing
- Active or previous inflammatory bowel disease requiring immunosuppressive treatment
- Uncontrolled significant cardiovascular or cerebrovascular disease
- HIV infection with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 agents, trophoblast cell surface antigen 2-targeted antibody drug conjugates, or topoisomerase I inhibitor-containing antibody drug conjugates
Research Team
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