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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)

Study acronym: ASCENT-GYN-01
StatusActive, Not Recruiting
PhasePhase 3
Started2024-08-28
View on ClinicalTrials.gov ↗

Amendment history

2026-07-28
Study Status v16
Re-verified, no change to tracked fields
2026-01-13
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v15
Trial statusRecruiting→Active, Not Recruiting
Study sites191→189
2025-10-28
Study Status, Contacts/Locations v14
Study sitesdetails revised at 3 of 191 sites
2025-10-03
Study Status, Contacts/Locations v13
Study sites187→191
2025-08-28
Study Status, Study Design, Outcome Measures, Contacts/Locations v12
Enrollment target520→640
Study sites171→187
Secondary endpoints9 entries, revised
[...] e Questionnaire-Core 30 Version 3.0 (EORTC QLQ-C30) at Week 1316 Change from baseline in Global Health Status (GHS)/Quality [...] e Questionnaire-Core 30 Version 3.0 (EORTC QLQ-C30) at Week 1316
Show 11 earlier versions
2025-06-23
Study Status, Contacts/Locations v11
Study sites162→171
2025-05-21
Study Status, Contacts/Locations v10
Study sites153→162
2025-05-02
Study Status, Contacts/Locations v9
Study sites104→153
2025-03-10
Study Identification, Study Status, Sponsor/Collaborators v8
Collaborators2 to 3 entries
Asia-Pacific Gynecologic Oncology Trials Group
2025-03-05
Study Status, Contacts/Locations v7
Study sites76→104
2025-02-07
Study Status, Contacts/Locations v6
Study sites47→76
2025-01-15
Study Status, Contacts/Locations v5
Study sites36→47
2024-12-19
Study Status, Contacts/Locations v4
Study sites12→36
2024-11-01
Study Status, Contacts/Locations v3
Study sites8→12
2024-10-11
Study Status, Contacts/Locations v2
Study sites5→8
2024-09-23
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations, References v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-09→confirmed 2024-08-28
Study sites0→5
Study title+36 characters
[...] l Cancer After Platinum-Based Chemotherapy and Immunotherapy (ASCENT-GYN-01/GOG-3104/ENGOT-en26)
2024-06-27
Original filing
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).
Trial Details
NCT Number NCT06486441
Lead Sponsor Gilead Sciences
Collaborators: GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT), Asia-Pacific Gynecologic Oncology Trials Group
Conditions Endometrial Cancer
Enrollment 640 participants
Start Date 2024-08-28
Primary Completion 2029-06 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-29