NCT06486441

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)

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 640 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Sacituzumab govitecan-hziy	Administered intravenously
DRUG	Doxorubicin	Administered intravenously
DRUG	Paclitaxel	Administered intravenously

Timeline

• Start date: 2024-08-28
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2024-07-03
• Last updated: 2026-01-15

Locations

189 sites across 19 countries: United States, Australia, Brazil, Canada, China, Czechia, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Poland, Singapore, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study