drugset / Trial / NCT03912415
Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy With and Without Bevacizumab as First-Line Treatment of Subjects With Advanced Cervical Cancer (FERMATA)
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a randomized, multicenter, double-blind, Phase 3 study of efficacy and safety of BCD-100 plus platinum-based chemotherapy with and without bevacizumab versus placebo plus platinum-based chemotherapy with and without bevacizumab
Timeline
- Start
- 2019-10-01
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BCD-100 | Monoclonal antibody | 3 mg/kg | Intravenous |
| Background | Bevacizumab | Monoclonal antibody | — | Intravenous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Cisplatin | Other / unclassified | — | Intravenous |
| Background | Paclitaxel | Small molecule | — | Intravenous |