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)

Launched by MERCK SHARP & DOHME LLC · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for women with advanced or recurrent endometrial cancer, specifically those whose cancer cells have normal proteins (called proficient mismatch repair or pMMR). The trial compares two treatment options: one group will receive a combination of two medications, sacituzumab tirumotecan (sac-TMT) and pembrolizumab, while the other group will receive pembrolizumab alone. Researchers want to find out if the combination treatment helps patients live longer and keeps the cancer from getting worse compared to the standard treatment.

To participate in this trial, women need to have a confirmed diagnosis of advanced or recurrent endometrial cancer that is pMMR. They should also have measurable signs of their cancer and have not received certain types of prior treatments. Participants can expect to receive either of the treatments and will be closely monitored by the research team. This trial is not yet recruiting, but it represents a potential new option for those facing challenges with their current cancer treatments.

Gender

FEMALE

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 curative-intent 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 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