Status:
RECRUITING
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy (ASCENT-GYN-01/GOG-3104/ENGOT-en26)
Lead Sponsor:
Gilead Sciences
Collaborating Sponsors:
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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 chemot...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
August 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
640 Patients enrolled
Trial Details
Trial ID
NCT06486441
Start Date
August 28 2024
End Date
June 1 2029
Last Update
October 30 2025
Active Locations (191)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
City of Hope
Duarte, California, United States, 91010
3
UC San Diego Medical Center
La Jolla, California, United States, 92093
4
Cedars-Sinai Cancer at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048