At a glance
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Phase Ib/II Study to Evaluate Safety and Tolerability of Neoadjuvant Nivolumab and Chemotherapy in Patients With Localized Triple-negative Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Paclitaxel, Carboplatin, and 5 other interventions for Triple Negative Breast Cancer. Active but no longer recruiting, targeting 15 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
-Given standard of care
-Given standard of care
-Given standard of care
-Will be provided by Bristol Myers Squibb
-Baseline, week 5, surgery, and at time of relapse (optional)
-Time of port placement (baseline), time of surgery, and time of recurrence (optional)
-Baseline, week 5, prior to surgery , post-surgery follow-up (typically 3-4 weeks post-surgery), and disease progression (optional)