Ignite Creation Date:
2024-07-17 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486441
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-27
Brief Title:
Study of Sacituzumab Govitecan Versus Treatment of Physicians Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy ASCENT-GYN-01GOG-3104ENGOT-en26
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Randomized Open-label Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physicians Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1PD-L1 Immunotherapy
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASCENT-GYN-01
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 chemotherapy and immunotherapy versus the treatment of physicians 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-511957-23 | OTHER | None | None |
| GOG-3104 | OTHER | None | None |
| ENGOT-en26 | OTHER | None | None |