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Official Title

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
Phase 3
Sponsor
Gilead Sciences
Enrollment
640
Timeline
Aug 2024 → Jun 2029
About This Study

The goal of this clinical study is to find out how the study drug, sacituzumab govitecan (SG) works in participants with endometrial cancer who have received prior treatment with platinum-based chemotherapy and immunotherapy, versus the treatment of physician's choice (TPC). The primary objectives of this study are to evaluate the effect of SG compared to TPC on progression-free survival (PFS) as assessed by blinded independent central review (BICR) and overall survival (OS).

Eligibility Criteria

Inclusion Criteria

  • 1Documented evidence of recurrent/persistent endometrial cancer (endometrial carcinoma or carcinosarcoma).
  • 2Up 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.
  • 3Eligible for treatment with either doxorubicin or paclitaxel as determined by the investigator.
  • 4Radiologically evaluable disease (either measurable or nonmeasurable) by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1.
  • 5Eastern Cooperative Oncology Group performance status score of 0 or 1.
  • 6Adequate organ function

Exclusion Criteria

  • 1Uterine leiomyosarcoma and endometrial stromal sarcomas are excluded.
  • 2Participants who are candidates for curative-intent therapy at the time of study enrollment.
  • 3Participants eligible for rechallenge with platinum-based chemotherapy as determined by the investigator.
  • 4Received any prior treatment with a Trop-2-directed antibody-drug conjugate (ADC).
  • 5Have an active second malignancy.
  • 6Have an active serious infection requiring systemic antimicrobial therapy.
  • 7Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months prior to randomization.
  • 8Have a positive serum pregnancy test or are breastfeeding for participants who are assigned female at birth.

Locations

191 sites participating in this study

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

Recruiting

University of Arkansas for Medical Sciences

Little Rock, Arkansas 72205

Recruiting

City of Hope

Duarte, California 91010

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →