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RecruitingLast updated: 22 October 2025

TroFuse-033: A trial recruiting people with advanced or recurrent pMMR endometrial cancer to see whether adding a targeted treatment to immunotherapy improves outcomesA 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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Female Reproductive System Cancers Gynaecological

Age

People18+

Trial acronym

TroFuse-033

Clinical summary

Summary

This study is for people with endometrial cancer that has returned, spread, or cannot be removed by surgery, and whose cancer cells have normal mismatch repair proteins (pMMR). 

It is testing whether adding sacituzumab tirumotecan (sac-TMT), a targeted therapy, to pembrolizumab immunotherapy helps people live longer without their cancer getting worse, compared to pembrolizumab alone.

Participants first receive a combination of chemotherapy and immunotherapy, and if their cancer does not grow, they continue treatment with either pembrolizumab alone or pembrolizumab plus sac-TMT. If the cancer progresses, participants may receive other combinations of the study medicines.

You may be eligible if you have pMMR advanced or recurrent endometrial cancer, and you haven't had treatments for your endometrial cancer, except for certain chemotherapy, radiation, or hormone treatments that were finished before starting this study.

Conditions

This trial is treating people with advanced or recurrent endometrial cancer that is confirmed pMMR

Eligibility

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 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 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

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

  • NCT06952504 *
  • 2870-033; 2024-519331-42-00; U1111-1315-0794; GOG-3119; ENGOT-EN29; TROFUSE-033; JRCT2011250020

Trial sponsor

Merck Sharp & Dohme LLC

Scientific Title

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)

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