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)
NCT06486441 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 640
Last updated 2026-01-15
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
Interventions
- DRUG
-
Administered intravenously
- DRUG
-
Doxorubicin
Administered intravenously
- DRUG
-
Administered intravenously
Sponsors & Collaborators
-
GOG Foundation
collaborator NETWORK -
European Network of Gynaecological Oncological Trial Groups (ENGOT)
collaborator OTHER -
Asia-Pacific Gynecologic Oncology Trials Group (APGOT)
collaborator UNKNOWN - lead INDUSTRY
Principal Investigators
-
Gilead Study Director · Gilead Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-28
- Primary Completion
- 2029-06-30
- Completion
- 2029-06-30
- FDA Drug
- Yes
Countries
- United States
- Australia
- Brazil
- Canada
- China
- Czechia
- France
- Germany
- Greece
- Hong Kong
- Israel
- Italy
- Japan
- Poland
- Singapore
- South Korea
- Spain
- Taiwan
- United Kingdom
Study Locations
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