drugset / Trial / NCT04331067
Neoadjuvant Nivolumab and Chemotherapy in Patients With Localized Triple-negative Breast Cancer
Phase 1/2
Terminated
15 enrolled
Washington University School of Medicine
Bristol-Myers Squibb · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Prior to Amendment #7: The hypothesis of this study is that the combination of cabiralizumab and nivolumab with neoadjuvant chemotherapy will decrease tumor associated macrophages (TAMs) and increase tumor infiltrating lymphocytes (TIL) compared to neoadjuvant chemotherapy plus nivolumab in patients with early stage triple-negative breast cancer (TNBC) and improve clinical outcomes. As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. The hypothesis of this study is that on-treatment tumor associated macrophages (TAMs) and tumor infiltrating lymphocytes (TILs) will improve (reduced TAMs, increased TILs) following neoadjuvant nivolumab with chemotherapy.
Timeline
- Start
- 2020-11-19
- Primary completion
- 2023-03-20
- Completion
- 2026-06-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabiralizumab | Monoclonal antibody | 4 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |
| Background | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |