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

L
Lisa Landrum, MD, PhD, MS

Primary Investigator

Recruiting
18 years - 100 years
Female
Phase 3
2 Locations

Brief description of study

What is the purpose of 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).

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Endometrial Cancer
  • Age: 18 years - 100 years
  • Gender: Female

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.

Updated on 07 May 2025. Study ID: CTO-GOG-3104, 23981

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