drugset / Trial / NCT05809895
Phase II Study Evaluating the Efficacy and Safety of Ociperlimab in Combination With Tislelizumab and Chemotherapy as First-line Treatment for Participants With Advanced Triple Negative Breast Cancer
RandomizedParallel-groupTriple-blindTreatment
Summary
The primary scientific question of interest of this study is whether the combination of ociperlimab, tislelizumab and chemotherapy improves progression-free survival (PFS) compared to the combination of placebo, pembrolizumab and chemotherapy as first-line therapy for adult men and women with advanced triple negative breast cancer (TNBC) whose tumors express programmed death ligand 1 (PD - L1) \[combined positive score (CPS) ≥10\], regardless of study treatment discontinuation or start of new anti-neoplastic therapy.
Timeline
- Start
- 2023-09-15
- Primary completion
- 2029-07-17
- Completion
- 2029-07-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ociperlimab | Monoclonal antibody | 900 mg | Intravenous |
| Comparator | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 90 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 100 mg/m2 | Intravenous |