Trial details
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
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Trial short name: GOG-3104 (ASCENT-GYN-01)
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
Principal Investigator: Dr. Lilian Gien
Cancer type: Gynecology
Cancer location: Uterine / Endometrial
Disease stage: Advanced Cancer
Trial phase: Phase 3
Intervention:
Registration #:
NCT06486441 
Contact e-mail: cancerclinicaltrials@sunnybrook.ca
Trial description:
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).
Inclusion Criteria 1. Recurrent/persistent endometrial cancer (endometrial carcinoma or carcinosarcoma) 2. Up to 3 prior lines of systemic therapy for endometrial cancer, including systemic platinum-based chemotherapy and anti-PD-1/PDL1 therapy, either in combination or separately 3. Tissue must be submitted within 4 weeks of randomization. Exclusion Criteria 1. Patients eligible for re-challenge with platinum-based chemotherapy as determined by the investigator 2. Uterine leiomyosarcoma and endometrial stromal sarcomas 3. Have had a prior anticancer biologic agent within 4 weeks prior to the first dose of study drug or have had prior chemotherapy, target small molecule therapy, or radiation therapy within 2 weeks prior to the first dose of study drug 4. Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease) or gastrointestinal perforation within 6months of enrollment
