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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
-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)
Washington University School of Medicine
St Louis, Missouri, United States
Percent Change in Tumor Infiltrating Lymphocytes (TILs)
-Stromal TIL score is defined as the percentage of tumor stroma area that was occupied by mononuclear inflammatory cells.
Time frame: Baseline and week 5
Percent Change in Tumor Associated Macrophages (TAMs)
Time frame: Baseline and week 5
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only)
Safety lead-in consists of the first 12 patients treated on the study (Arm A and Arm B).
Time frame: From start of treatment through 100 days after last day of study treatment or surgery whichever occurs first (approximately 16 weeks)
Pathological Complete Response (pCR)
-A pathologic complete response (pCR) is defined as no histology evidence of invasive tumor cells in the surgical breast specimen and sentinel or axillary lymph nodes.
Time frame: At time of surgery (average of 12 weeks)
Recurrence-free Survival (RFS)
-RFS is defined from time of surgery to the earliest time of recurrence, time to development of a second cancer, or time to death from any cause.
Time frame: Through completion of follow-up (estimated to be 3 years and 12 weeks)
Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events
Treatment related means either possibly, probably, or definitely related to nivolumab
Time frame: From start of treatment through 100 days after last infusion of study treatment or surgery whichever occurs first (approximately 16 weeks)
Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events
Treatment related means either possibly, probably, or definitely related to carboplatin
Time frame: From start of treatment through 100 days after last infusion of study treatment or surgery whichever occurs first (approximately 16 weeks)
Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events
Treatment related means either possibly, probably, or definitely related to paclitaxel
Time frame: From start of treatment through 100 days after last infusion of study treatment or surgery whichever occurs first (approximately 16 weeks)
Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events
Treatment related means either possibly, probably, or definitely related to cabiralizumab
Time frame: From start of treatment through 100 days after last infusion of study treatment or surgery whichever occurs first (approximately 16 weeks)
Compare the Percent Change of Tumor Associated Macrophages (TAMs) Between Participants Who Achieve pCR Versus Those Who do Not
-A pathologic complete response (pCR) is defined as no histology evidence of invasive tumor cells in the surgical breast specimen and sentinel or axillary lymph nodes.
Time frame: At time of surgery (average of 12 weeks)
Compare the Percent Change of Tumor Infiltrating Lymphocytes (TILs) Between Participants Who Achieve pCR Versus Those Who do Not
* Stromal TIL score is defined as the percentage of tumor stroma area that was occupied by mononuclear inflammatory cells. * A pathologic complete response (pCR) is defined as no histology evidence of invasive tumor cells in the surgical breast specimen and sentinel or axillary lymph nodes.
Time frame: At time of surgery (average of 12 weeks)
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