Trial Outcomes & Findings for Neoadjuvant Nivolumab and Chemotherapy in Patients With Localized Triple-negative Breast Cancer (NCT NCT04331067)

Last Updated: 2025-04-23

Results Overview

-Stromal TIL score is defined as the percentage of tumor stroma area that was occupied by mononuclear inflammatory cells.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

15 participants

Primary outcome timeframe

Baseline and week 5

Results posted on

2025-04-23

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A: Neoadjuvant Chemo + Nivolumab -Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.	Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel. * Cabiralizumab will be given IV at a dose of 4 mg/kg every 2 weeks for 12 weeks.	Unrandomized Arm: Neoadjuvant Chemo + Nivolumab * As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. Remaining patients will be enrolled in single arm study. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.
Overall Study STARTED	6	6	3
Overall Study COMPLETED	4	3	2
Overall Study NOT COMPLETED	2	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Neoadjuvant Chemo + Nivolumab -Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.	Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel. * Cabiralizumab will be given IV at a dose of 4 mg/kg every 2 weeks for 12 weeks.	Unrandomized Arm: Neoadjuvant Chemo + Nivolumab * As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. Remaining patients will be enrolled in single arm study. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.
Overall Study Adverse Event	1	3	1
Overall Study Physician decision - patient not compliant with visits	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Neoadjuvant Chemo + Nivolumab n=6 Participants -Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.	Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab n=6 Participants As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel. * Cabiralizumab will be given IV at a dose of 4 mg/kg every 2 weeks for 12 weeks.	Unrandomized Arm: Neoadjuvant Chemo + Nivolumab n=3 Participants * As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. Remaining patients will be enrolled in single arm study. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.	Total n=15 Participants Total of all reporting groups
Age, Continuous	55 years n=5 Participants	55.5 years n=7 Participants	62 years n=5 Participants	57 years n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	15 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	14 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	3 participants n=5 Participants	15 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and week 5

Population: Arm A and Unrandomized Arm were analyzed together as the treatment received was the same. There were 2 participants with missing data in Arm A/Unrandomized Arm and 2 participants with missing data in Arm B and these participants were not included in the analysis.

-Stromal TIL score is defined as the percentage of tumor stroma area that was occupied by mononuclear inflammatory cells.

Outcome measures

Outcome measures
Measure	Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab n=7 Participants -Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.	Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab n=4 Participants As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel. * Cabiralizumab will be given IV at a dose of 4 mg/kg every 2 weeks for 12 weeks.	Unrandomized Arm: Neoadjuvant Chemo + Nivolumab * As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. Remaining patients will be enrolled in single arm study. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.
Percent Change in Tumor Infiltrating Lymphocytes (TILs)	95.2 percent change Standard Deviation 121	1.63 percent change Standard Deviation 82.5	—

PRIMARY outcome

Timeframe: Baseline and week 5

Population: Arm A and Unrandomized Arm were analyzed together as the treatment received was the same. There were 3 participants with missing data in Arm A/Unrandomized Arm and 3 participants with missing data in Arm B and these participants were not included in the analysis.

Outcome measures

Outcome measures
Measure	Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab n=6 Participants -Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.	Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab n=3 Participants As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel. * Cabiralizumab will be given IV at a dose of 4 mg/kg every 2 weeks for 12 weeks.	Unrandomized Arm: Neoadjuvant Chemo + Nivolumab * As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. Remaining patients will be enrolled in single arm study. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.
Percent Change in Tumor Associated Macrophages (TAMs)	31.8 percent change Standard Deviation 32.1	-38.7 percent change Standard Deviation 63.6	—

PRIMARY outcome

Timeframe: From start of treatment through 100 days after last day of study treatment or surgery whichever occurs first (approximately 16 weeks)

Safety lead-in consists of the first 12 patients treated on the study (Arm A and Arm B).

Outcome measures

Outcome measures
Measure	Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab n=6 Participants -Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.	Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab n=6 Participants As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel. * Cabiralizumab will be given IV at a dose of 4 mg/kg every 2 weeks for 12 weeks.	Unrandomized Arm: Neoadjuvant Chemo + Nivolumab * As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. Remaining patients will be enrolled in single arm study. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 myositis	0 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 anemia	4 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 anemia	2 Participants	4 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 lymph node pain	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 supraventricular tachycardia	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 adrenal insufficiency	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 diabetes	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 hypoparathyroidism	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 hypothyroidism	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 blurred vision	1 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 eye pain	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 periorbital edema	0 Participants	3 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 periorbital edema	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 photophobia	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 uveitis	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 watering eyes	0 Participants	3 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 abdominal pain	2 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 constipation	2 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 diarrhea	2 Participants	3 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 dry mouth	0 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 dyspepsia	2 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 dysphagia	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 gastroesophageal reflux disease	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 gas pain	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 gastrointestinal pain	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 mucositis oral	0 Participants	5 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 nausea	5 Participants	5 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 vomiting	2 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 vomiting	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 chills	2 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 edema limbs	1 Participants	3 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 edema trunk	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 fatigue	6 Participants	4 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 fever	1 Participants	3 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 flu like symptoms	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 generalized body aches	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 localized edema	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 neck edema	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 non-cardiac chest pain	3 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 allergic reaction	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 bronchitis	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 cold symptoms	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 conjunctivitis	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 eye infection	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 folliculitis	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 sepsis	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 thrush	1 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 thrush	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 urinary tract infection	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 fall	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 infusion related reaction	1 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 seroma	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 alanine aminotransferase increased	4 Participants	6 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 alkaline phosphtase increased	3 Participants	5 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 aspartate aminotransferase increased	1 Participants	4 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 aspartate aminotransferase increased	0 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 blood lactate dehydrogenase increased	4 Participants	6 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 cardiac troponin I increased	0 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 cardiac troponin T increased	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 cholesterol high	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 CPK increased	0 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 CPK increased	0 Participants	4 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 creatinine increased	1 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 creatinine increased	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 fibrinogen decreased	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 haptoglobin decreased	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 INR increased	0 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 lipase increased	1 Participants	5 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 lymphocyte count decreased	2 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 lymphocyte count decreased	1 Participants	4 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 neutrophil count decreased	2 Participants	3 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 neutrophil count decreased	2 Participants	3 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 platelet count decreased	3 Participants	4 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 platelet count decreased	1 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 thyroid stimulating hormone increased	1 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 weight gain	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 weight loss	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 weight loss	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 white blood cell decreased	3 Participants	3 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 white blood cell decreased	2 Participants	3 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 anorexia	1 Participants	3 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 dehydration	1 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 dehydration	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 hypercalcemia	1 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 hyperglycemia	2 Participants	3 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 hyperkalemia	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 hypernatremia	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 hypernatremia	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 hypertriglyceridemia	1 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 hyperuricemia	0 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 hypoalbuminemia	1 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 hypocalcemia	1 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 hypocalcemia	0 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 hypoglycemia	0 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 hypokalemia	1 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 hypokalemia	0 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 hypomagnesemia	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 hypomagnesemia	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 hyponatremia	2 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 hypophosphatemia	0 Participants	3 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 arthralgia	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 arthritis	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 back aches	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 back pain	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 back spasms	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 bilateral rib pain	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 bone pain	2 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 bone pain	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 generalized muscle weakness	2 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 generalized muscle weakness	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 muscle cramp	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 muscle soreness	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 myalgia	1 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 rhabdomyolysis	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 shoulder pain	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 dizziness	4 Participants	4 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 dysgeusia	2 Participants	3 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 encephalopathy	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 headache	4 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 jitters	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 memory impairment	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 peripheral motor neuropathy	1 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 peripheral sensory neuropathy	2 Participants	5 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 peripheral sensory neuropathy	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 syncope	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 tremors	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 agitation	2 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 altered mental state	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 depression	2 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 insomnia	2 Participants	3 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 mania	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 acute kidney injury	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 glucosuria	3 Participants	3 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 hematuria	1 Participants	3 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 proteinuria	1 Participants	3 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 urinary urgency	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 areola pain	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 breast edema	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 breast pain	1 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) grade 1-2 irregular menstruation	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 allergic rhinitis	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 cough	2 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 dyspnea	4 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 epistaxis	3 Participants	3 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 productive cough	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 sore throat	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 alopecia	4 Participants	4 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 dermatitis radiation	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 dry skin	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 flat, lacy rash	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 hyperhidrosis	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 macular rash	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 palmar-plantar erythrodysesthesia syndrome	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 photosensitivity	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 pruritus	1 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 rash acneiform	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 rash maculo-papular	3 Participants	4 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 skin pain on chest and arms	0 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 skin ulceration	0 Participants	2 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 hot flashes	2 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 hypertension	1 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 hypertension	2 Participants	3 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 hypotension	1 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 hypotension	1 Participants	0 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 1-2 thromboembolic event	2 Participants	1 Participants	—
Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) Grade 3-4 thromboembolic event	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: At time of surgery (average of 12 weeks)

Population: 1 participant in Arm A and 1 participant in Arm B did not have surgery.

-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.

Outcome measures

Outcome measures
Measure	Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab n=5 Participants -Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.	Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab n=5 Participants As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel. * Cabiralizumab will be given IV at a dose of 4 mg/kg every 2 weeks for 12 weeks.	Unrandomized Arm: Neoadjuvant Chemo + Nivolumab n=3 Participants * As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. Remaining patients will be enrolled in single arm study. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.
Pathological Complete Response (pCR)	3 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Through completion of follow-up (estimated to be 3 years and 12 weeks)

-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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of treatment through 100 days after last infusion of study treatment or surgery whichever occurs first (approximately 16 weeks)

Treatment related means either possibly, probably, or definitely related to nivolumab

Outcome measures

Outcome measures
Measure	Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab n=6 Participants -Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.	Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab n=6 Participants As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel. * Cabiralizumab will be given IV at a dose of 4 mg/kg every 2 weeks for 12 weeks.	Unrandomized Arm: Neoadjuvant Chemo + Nivolumab n=3 Participants * As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. Remaining patients will be enrolled in single arm study. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.
Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events Anemia	1 Participants	1 Participants	1 Participants
Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events Thrush	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events Aspartate aminotransferase increased	0 Participants	2 Participants	0 Participants
Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events CPK increased	0 Participants	3 Participants	0 Participants
Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events Creatinine increased	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events Lymphocyte count decreased	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events Neutrophil count decreased	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events Platelet count decreased	0 Participants	2 Participants	0 Participants
Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events Weight gain	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events Dehydration	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events Hypocalcemia	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events Hypokalemia	0 Participants	1 Participants	1 Participants
Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events Generalized muscle weakness	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events Myositis	0 Participants	2 Participants	0 Participants
Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events Acute kidney injury	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From start of treatment through 100 days after last infusion of study treatment or surgery whichever occurs first (approximately 16 weeks)

Treatment related means either possibly, probably, or definitely related to carboplatin

Outcome measures

Outcome measures
Measure	Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab n=6 Participants -Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.	Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab n=6 Participants As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel. * Cabiralizumab will be given IV at a dose of 4 mg/kg every 2 weeks for 12 weeks.	Unrandomized Arm: Neoadjuvant Chemo + Nivolumab n=3 Participants * As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. Remaining patients will be enrolled in single arm study. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.
Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events Anemia	2 Participants	2 Participants	1 Participants
Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events Sepsis	1 Participants	0 Participants	0 Participants
Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events Thrush	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events Aspartate aminotransferase increased	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events Lymphocyte count decreased	0 Participants	2 Participants	0 Participants
Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events Neutrophil count decreased	1 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events Platelet count decreased	1 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events White blood cell decreased	1 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events Dehydration	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events Hypernatremia	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events Hypocalcemia	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events Hypokalemia	0 Participants	1 Participants	1 Participants
Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events Hypomagnesemia	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events Peripheral sensory neuropathy	1 Participants	0 Participants	0 Participants
Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events Acute kidney injury	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events Hypotension	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From start of treatment through 100 days after last infusion of study treatment or surgery whichever occurs first (approximately 16 weeks)

Treatment related means either possibly, probably, or definitely related to paclitaxel

Outcome measures

Outcome measures
Measure	Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab n=6 Participants -Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.	Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab n=6 Participants As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel. * Cabiralizumab will be given IV at a dose of 4 mg/kg every 2 weeks for 12 weeks.	Unrandomized Arm: Neoadjuvant Chemo + Nivolumab n=3 Participants * As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. Remaining patients will be enrolled in single arm study. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.
Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events Anemia	2 Participants	2 Participants	1 Participants
Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events Sepsis	1 Participants	0 Participants	0 Participants
Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events Thrush	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events Aspartate aminotransferase increased	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events Lymphocyte count decreased	0 Participants	2 Participants	0 Participants
Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events Neutrophil count decreased	1 Participants	2 Participants	0 Participants
Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events Platelet count decreased	1 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events Weight gain	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events White blood cell decreased	1 Participants	2 Participants	0 Participants
Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events Dehydration	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events Hypernatremia	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events Hypocalcemia	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events Hypokalemia	0 Participants	1 Participants	1 Participants
Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events Hypomagnesemia	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events Peripheral sensory neuropathy	1 Participants	0 Participants	0 Participants
Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events Acute kidney injury	0 Participants	1 Participants	0 Participants
Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events Hypotension	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From start of treatment through 100 days after last infusion of study treatment or surgery whichever occurs first (approximately 16 weeks)

Population: This outcome measure is only for Arm B as that arm is the only arm that received cabiralizumab.

Treatment related means either possibly, probably, or definitely related to cabiralizumab

Outcome measures

Outcome measures
Measure	Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab -Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.	Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab n=6 Participants As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel. * Cabiralizumab will be given IV at a dose of 4 mg/kg every 2 weeks for 12 weeks.	Unrandomized Arm: Neoadjuvant Chemo + Nivolumab * As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. Remaining patients will be enrolled in single arm study. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.
Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events Weight gain	—	1 Participants	—
Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events Anemia	—	1 Participants	—
Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events Periorbital edema	—	1 Participants	—
Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events Uveitis	—	1 Participants	—
Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events Thrush	—	1 Participants	—
Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events Aspartate aminotransferase increased	—	2 Participants	—
Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events CPK increased	—	4 Participants	—
Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events Lymphocyte count decreased	—	1 Participants	—
Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events Neutrophil count decreased	—	1 Participants	—
Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events Platelet count decreased	—	2 Participants	—
Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events Dehydration	—	1 Participants	—
Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events Hypocalcemia	—	1 Participants	—
Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events Hypokalemia	—	1 Participants	—
Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events Generalized muscle weakness	—	1 Participants	—
Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events Myositis	—	2 Participants	—
Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events Acute kidney injury	—	1 Participants	—

SECONDARY outcome

Timeframe: At time of surgery (average of 12 weeks)

Population: Arm A and Unrandomized Arm were analyzed together as the treatment received was the same. There were 2 participants with missing data in Arm A/Unrandomized Arm and 3 participants with missing data in Arm B and these participants were not included in the analysis.

-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.

Outcome measures

Outcome measures
Measure	Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab n=7 Participants -Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.	Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab n=3 Participants As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel. * Cabiralizumab will be given IV at a dose of 4 mg/kg every 2 weeks for 12 weeks.	Unrandomized Arm: Neoadjuvant Chemo + Nivolumab * As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. Remaining patients will be enrolled in single arm study. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.
Compare the Percent Change of Tumor Associated Macrophages (TAMs) Between Participants Who Achieve pCR Versus Those Who do Not non-pCR	41.9 percent change Standard Deviation 92.1	82.8 percent change Standard Deviation NA There is no standard deviation as there is only data for one participant.	—
Compare the Percent Change of Tumor Associated Macrophages (TAMs) Between Participants Who Achieve pCR Versus Those Who do Not pCR	166 percent change Standard Deviation 134	-19.9 percent change Standard Deviation 107	—

SECONDARY outcome

Timeframe: At time of surgery (average of 12 weeks)

Population: Arm A and Unrandomized Arm were analyzed together as the treatment received was the same. There were 3 participants with missing data in Arm A/Unrandomized Arm and 4 participants with missing data in Arm B and these participants were not included in the analysis.

* 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.

Outcome measures

Outcome measures
Measure	Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab n=6 Participants -Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.	Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab n=2 Participants As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel. * Cabiralizumab will be given IV at a dose of 4 mg/kg every 2 weeks for 12 weeks.	Unrandomized Arm: Neoadjuvant Chemo + Nivolumab * As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. Remaining patients will be enrolled in single arm study. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.
Compare the Percent Change of Tumor Infiltrating Lymphocytes (TILs) Between Participants Who Achieve pCR Versus Those Who do Not non-pCR	11.1 percent change Standard Deviation 19.9	32.2 percent change Standard Deviation NA There is no standard deviation as there is only data for one participant.	—
Compare the Percent Change of Tumor Infiltrating Lymphocytes (TILs) Between Participants Who Achieve pCR Versus Those Who do Not pCR	52.5 percent change Standard Deviation 29.9	-90.6 percent change Standard Deviation NA There is no standard deviation as there is only data for one participant.	—

Adverse Events

Arm A: Neoadjuvant Chemo + Nivolumab

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

Unrandomized Arm: Neoadjuvant Chemo + Nivolumab

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A: Neoadjuvant Chemo + Nivolumab n=6 participants at risk -Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.	Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab n=6 participants at risk As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel. * Cabiralizumab will be given IV at a dose of 4 mg/kg every 2 weeks for 12 weeks.	Unrandomized Arm: Neoadjuvant Chemo + Nivolumab n=3 participants at risk * As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. Remaining patients will be enrolled in single arm study. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.
Blood and lymphatic system disorders Anemia	0.00% 0/6 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).	16.7% 1/6 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).	0.00% 0/3 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).
Gastrointestinal disorders Vomiting	0.00% 0/6 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).	16.7% 1/6 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).	0.00% 0/3 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).
Infections and infestations Sepsis	16.7% 1/6 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).	0.00% 0/6 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).	0.00% 0/3 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).
Investigations Neutrophil count decreased	16.7% 1/6 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).	0.00% 0/6 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).	0.00% 0/3 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).
Investigations Platelet count decreased	0.00% 0/6 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).	16.7% 1/6 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).	0.00% 0/3 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).	16.7% 1/6 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).	0.00% 0/3 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/6 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).	33.3% 2/6 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).	0.00% 0/3 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).	16.7% 1/6 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).	0.00% 0/3 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).
Vascular disorders Thromboembolic event	16.7% 1/6 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).	16.7% 1/6 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).	0.00% 0/3 • Adverse events were collected from start of treatment through 100 days after last treatment or day of surgery, whichever was first. All-cause mortality was collected from start of treatment through completion of follow-up (up to 36 months).

Other adverse events

Additional Information

Andrew Davis, M.D.

Washington University School of Medicine

Phone: 314-273-3581

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place