Trials / Active Not Recruiting
Active Not RecruitingNCT04331067
Neoadjuvant Nivolumab and Chemotherapy in Patients With Localized Triple-negative Breast Cancer
Phase Ib/II Study to Evaluate Safety and Tolerability of Neoadjuvant Nivolumab and Chemotherapy in Patients With Localized Triple-negative Breast Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Paclitaxel | -Given standard of care |
| DRUG | Carboplatin | -Given standard of care |
| BIOLOGICAL | Nivolumab | -Given standard of care |
| BIOLOGICAL | Cabiralizumab | -Will be provided by Bristol Myers Squibb |
| PROCEDURE | Tumor biopsy | -Baseline, week 5, surgery, and at time of relapse (optional) |
| PROCEDURE | Bone marrow | -Time of port placement (baseline), time of surgery, and time of recurrence (optional) |
| PROCEDURE | Blood draw | -Baseline, week 5, prior to surgery , post-surgery follow-up (typically 3-4 weeks post-surgery), and disease progression (optional) |
Timeline
- Start date
- 2020-11-19
- Primary completion
- 2023-03-20
- Completion
- 2026-05-31
- First posted
- 2020-04-02
- Last updated
- 2025-04-23
- Results posted
- 2024-05-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04331067. Inclusion in this directory is not an endorsement.