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Comparing sacituzumab govitecan to physician's choice treatment for endometrial cancer

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

Phase 3 Interventional Gilead Sciences · NCT06486441

This study is testing if a new treatment called sacituzumab govitecan can help people with endometrial cancer who have already tried other therapies feel better and live longer compared to the treatment their doctor chooses.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment520 (estimated)
Ages18 Years and up
SexFemale
SponsorGilead Sciences Industry-sponsored
Drugs / interventionschemotherapy, doxorubicin, sacituzumab, immunotherapy
Locations162 sites (Little Rock, Arkansas and 161 other locations)
Trial IDNCT06486441 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the effectiveness of sacituzumab govitecan (SG) in patients with endometrial cancer who have previously undergone platinum-based chemotherapy and immunotherapy. Participants will be compared against those receiving treatment of physician's choice (TPC) to assess progression-free survival (PFS) and overall survival (OS). The study will involve up to three prior lines of systemic therapy and will utilize blinded independent central review for outcome assessment.

Who should consider this trial

Good fit: Ideal candidates include individuals with recurrent or persistent endometrial cancer who have received prior platinum-based chemotherapy and immunotherapy.

Not a fit: Patients with uterine leiomyosarcoma or endometrial stromal sarcomas, or those eligible for curative-intent therapy, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option that improves survival outcomes for patients with recurrent endometrial cancer.

How similar studies have performed: Other studies have shown promising results with similar approaches in treating endometrial cancer, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Documented evidence of recurrent/persistent endometrial cancer (endometrial carcinoma or carcinosarcoma).
* Up to 3 prior lines of systemic therapy for endometrial cancer, including systemic platinum-based chemotherapy and anti-PD-1/PD-L1 therapy, either in combination or separately.
* Eligible for treatment with either doxorubicin or paclitaxel as determined by the investigator.
* Radiologically evaluable disease (either measurable or nonmeasurable) by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1.
* Eastern Cooperative Oncology Group performance status score of 0 or 1.
* Adequate organ function

Key Exclusion Criteria:

* Uterine leiomyosarcoma and endometrial stromal sarcomas are excluded.
* Participants who are candidates for curative-intent therapy at the time of study enrollment.
* Participants eligible for rechallenge with platinum-based chemotherapy as determined by the investigator.
* Received any prior treatment with a Trop-2-directed antibody-drug conjugate (ADC).
* Have an active second malignancy.
* Have an active serious infection requiring systemic antimicrobial therapy.
* Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months prior to randomization.
* Have a positive serum pregnancy test or are breastfeeding for participants who are assigned female at birth.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Little Rock, Arkansas and 161 other locations

+112 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 Cancer
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.