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Neoadjuvant Nivolumab and Chemotherapy in Patients With Localized Triple-negative Breast Cancer

NCT04331067 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-06

Study results available
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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

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)

Sponsors & Collaborators

Principal Investigators

  • Andrew Davis, M.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-19
Primary Completion
2023-03-20
Completion
2026-07-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04331067 on ClinicalTrials.gov