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New treatment for endometrial cancer after previous therapies

A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy (MK-2870-005/ENGOT-en23/GOG-3095)

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT06132958

This study is testing a new treatment called sacituzumab tirumotecan for women with endometrial cancer who have already tried other therapies to see if it works better than standard chemotherapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment710 (estimated)
Ages18 Years and up
SexFemale
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionssacituzumab, trastuzumab, chemotherapy, Immunotherapy, doxorubicin
Locations241 sites (Mobile, Alabama and 240 other locations)
Trial IDNCT06132958 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of sacituzumab tirumotecan in patients with endometrial cancer who have previously undergone platinum-based chemotherapy and immunotherapy. The study aims to compare the outcomes of patients receiving sacituzumab tirumotecan against those receiving standard chemotherapy treatments. Participants will be monitored for overall survival and progression-free survival to determine if the new treatment offers significant benefits over existing options.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically-confirmed endometrial carcinoma who have previously received platinum-based chemotherapy and immunotherapy.

Not a fit: Patients with neuroendocrine tumors, endometrial sarcoma, or severe ocular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option that improves survival rates for patients with advanced endometrial cancer.

How similar studies have performed: Other studies have shown promise with antibody-drug conjugates in treating various cancers, suggesting potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
* Has radiographically evaluable disease, either measurable or nonmeasurable per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (BICR).
* Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.

Exclusion Criteria:

* Has neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas
* 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 had a recurrence of endometrial carcinoma or carcinosarcoma more than \>12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting. Note: 1) If Immunotherapy-based treatment is administered in the recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from time of adjuvant therapy 2) For Stage IVb disease, treatment that includes gynecological surgery followed by a platinum-based regimen is NOT considered curative-intent per protocol and does not require platinum rechallenge in the recurrent setting, regardless of the duration of the platinum-free interval
* Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma
* Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has received prior treatment with single-agent nonplatinum based chemotherapy in the third-line setting
* Has received prior treatment with a trophoblast cell surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC) (eg, sacituzumab govitecan)
* Has received prior treatment with a topoisomerase I inhibitor-containing ADC (eg, sacituzumab govitecan or fam-trastuzumab deruxtecan-nxki)
* Has previously received both single-agent paclitaxel and single-agent doxorubicin in any setting for prior treatment of endometrial cancer
* Requires recurrent drainage of effusions (e.g., pleural, ascitic, etc.) within 6 weeks before randomization

Where this trial is running

Mobile, Alabama and 240 other locations

+191 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 CancerEndometrial cancerAntibody-drug conjugateTrophoblast cell-surface antigen 2
Last reviewed 2026-06-13 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.