drugset / Trial / 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)
Phase 3
Active not recruiting
640 enrolled
Gilead Sciences
Asia-Pacific Gynecologic Oncology Trials Group · collabEuropean Network of Gynaecological Oncological Trial Groups (ENGOT) · collabGOG Foundation · collab
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2024-08-28
- Primary completion
- 2029-06
- Completion
- 2029-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Sacituzumab Govitecan | Monoclonal antibody | 10 mg/kg | Intravenous |