drugset / Trial / NCT06963905
Saci Nivo Rela for TNBC
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, open-label, phase Ib study to assess safety and efficacy of sacituzumab govitecan plus nivolumab or sacituzumab govitecan plus a fixed dose combination of nivolumab and relatlimab in patients with any programmed cell death-ligand 1 (PD-L1) status metastatic, triple negative breast cancer on routine testing with one prior line of cytotoxic chemotherapy with or without immunotherapy in the metastatic setting. The study treatment will be continued until the progression of disease, unacceptable toxicity, death, or withdrawal of consent for any reason.
Timeline
- Start
- 2025-12-29
- Primary completion
- 2030-12
- Completion
- 2030-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Nivolumab | Monoclonal antibody | 360 mg | Intravenous |
| Comparator | Relatlimab | Monoclonal antibody | 120 mg | Intravenous |
| Comparator | Relatlimab | Monoclonal antibody | 360 unknown | Intravenous |
| Comparator | Sacituzumab Govitecan | Monoclonal antibody | 5 mg/kg | Intravenous |
| Comparator | Sacituzumab Govitecan | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Comparator | Sacituzumab Govitecan | Monoclonal antibody | 10 mg/kg | Intravenous |