Triple Negative Breast Cancer
Conditions
Brief 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.
Interventions
DRUGPaclitaxel
-Given standard of care
DRUGCarboplatin
-Given standard of care
BIOLOGICALNivolumab
-Given standard of care
BIOLOGICALCabiralizumab
-Will be provided by Bristol Myers Squibb
PROCEDURETumor biopsy
-Baseline, week 5, surgery, and at time of relapse (optional)
PROCEDUREBone marrow
-Time of port placement (baseline), time of surgery, and time of recurrence (optional)
PROCEDUREBlood draw
-Baseline, week 5, prior to surgery , post-surgery follow-up (typically 3-4 weeks post-surgery), and disease progression (optional)
Sponsors
Bristol-Myers Squibb
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed newly diagnosed ER-/HER2- breast cancer. ER and PR \< Allred score of 3 or \< 1% positive staining cells in the invasive component of the tumor. HER2 negative by FISH or IHC staining 0 or 1+ according to NCCN guidelines. * Clinical stage II or III (by AJCC 8th edition at least T2, any N, M0 or if N+ then any T) breast cancer eligible for neoadjuvant chemotherapy with complete surgical excision of the breast cancer after neoadjuvant therapy as the treatment goal. * Tumor size at least 2 cm in one dimension by clinical or radiographic exam (WHO criteria). Patients with histologically confirmed or clinically palpable lymph nodes may be enrolled regardless of tumor size. A palpable mass is not required as long as the mass is at least 2 cm in one dimension by radiographic exam. 2D measurements should be completed during screening if available. * No prior therapy for this disease * At least 18 years of age. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 * Normal bone marrow and organ function as defined below: * Leukocytes ≥ 2,000/mcL (stable off any growth factor within 4 weeks of first study treatment administration) * Absolute neutrophil count ≥ 1,500/mcL (stable off any growth factor within 4 weeks of first study treatment administration) * Platelets ≥ 100,000/mcL (stable off any growth factor within 4 weeks of first study treatment administration) * Hemoglobin ≥8.5 g/dl (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration) * Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) (except participants with Gilbert's Syndrome who must have normal direct bilirubin) * AST(SGOT)/ALT(SGPT) ≤ 2.0 x IULN * Alkaline phosphatase \<2.5 x ULN * Serum creatinine \< 1.5 x ULN or creatinine clearance \> 40 mL/min by Cockcroft-Gault * Albumin ≥ 3 g/dL * INR and aPTT \<1.5 x IULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose). * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study treatment. * Women must not be breastfeeding. * WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatment(s) and for a total of 5 months post-treatment completion. * Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). * Consent for fresh pre-treatment, on-treatment, biopsy samples at acceptable clinical risk, as judged by the investigator. * Participants must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing
Exclusion criteria
* Prior treatment with immunotherapy for cancer * Known metastatic disease * Known invasive cancer in contralateral breast * Patients with a previous history of non-breast malignancy are eligible only if they meet the following criteria for a cancer survivor: * Has undergone potentially curative therapy for all prior malignancies AND * Has been considered disease-free for at least 1 year (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix. * Currently receiving any other investigational agents. * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel, carboplatin, nivolumab, or other agents used in the study. Patients who have received multiple blood transfusions. * Evidence of uncontrolled ongoing or active infection, requiring parenteral anti-bacterial, anti-viral, or anti-fungal therapy ≤ 7 days prior to administration of study treatment. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible. * Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation. * History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease (Crohn's disease and ulcerative colitis), vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis. * Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible. * Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible. * Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: * Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations * Rash must cover less than 10% of body surface area (BSA) * Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%) * No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation \[PUVA\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids) * History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. * Uncontrolled or significant cardiovascular disease * History of any chronic hepatitis as evidenced by the following: * Positive test for hepatitis B surface antigen * Positive test for qualitative hepatitis C viral load (by polymerase chain reaction \[PCR\]). * Positive test for latent tuberculosis (TB) at screening (e.g. T-SPOT or Quantiferon test) or evidence of active TB. * Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study with the exception of the planned breast cancer surgery that is part of the trial design. Participants must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of study treatment. * Any uncontrolled medical condition which, in the opinion of the Investigator, would pose a risk to participant safety or interfere with study participation or interpretation of individual participant results. * Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to Cycle 1, Day 1. * Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled. * The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed. The use of replacement doses of prednisone or other corticosteroid for adrenocortical insufficiency is allowed * Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease. * Evidence of coagulopathy or bleeding diathesis. * Ascites needing paracentesis or medical management. * Patients positive for human immunodeficiency virus (HIV) are NOT excluded from this study, but HIV-positive patients must have: * A stable regimen of highly active anti-retroviral therapy (HAART) * No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections * A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Tumor Infiltrating Lymphocytes (TILs) | Baseline and week 5 | -Stromal TIL score is defined as the percentage of tumor stroma area that was occupied by mononuclear inflammatory cells. |
| Percent Change in Tumor Associated Macrophages (TAMs) | Baseline and week 5 | — |
| Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | 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 |
| Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | 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 |
| Pathological Complete Response (pCR) | At time of surgery (average of 12 weeks) | -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. |
| Compare the Percent Change of Tumor Associated Macrophages (TAMs) Between Participants Who Achieve pCR Versus Those Who do Not | At time of surgery (average of 12 weeks) | -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. |
| Compare the Percent Change of Tumor Infiltrating Lymphocytes (TILs) Between Participants Who Achieve pCR Versus Those Who do Not | At time of surgery (average of 12 weeks) | * 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. |
| Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events | 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 cabiralizumab |
| Recurrence-free Survival (RFS) | 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. |
| Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| 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. | 6 |
| 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. | 3 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 | 1 |
| Overall Study | Physician decision - patient not compliant with visits | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Arm A: Neoadjuvant Chemo + Nivolumab | Total | Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab |
|---|---|---|---|---|
| Age, Continuous | 55 years | 57 years | 62 years | 55.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 14 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 9 Participants | 1 Participants | 4 Participants |
| Region of Enrollment United States | 6 participants | 15 participants | 3 participants | 6 participants |
| Sex: Female, Male Female | 6 Participants | 15 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 6 | 1 / 6 | 0 / 3 |
| other Total, other adverse events | 6 / 6 | 6 / 6 | 3 / 3 |
| serious Total, serious adverse events | 1 / 6 | 3 / 6 | 0 / 3 |
Outcome results
Primary
Percent Change in Tumor Associated Macrophages (TAMs)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Percent Change in Tumor Associated Macrophages (TAMs) | 31.8 percent change | Standard Deviation 32.1 |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Percent Change in Tumor Associated Macrophages (TAMs) | -38.7 percent change | Standard Deviation 63.6 |
Primary
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Percent Change in Tumor Infiltrating Lymphocytes (TILs) | 95.2 percent change | Standard Deviation 121 |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Percent Change in Tumor Infiltrating Lymphocytes (TILs) | 1.63 percent change | Standard Deviation 82.5 |
Primary
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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 anemia | 4 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 abdominal pain | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 gas pain | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 gastrointestinal pain | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 flu like symptoms | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 generalized body aches | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 INR increased | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 platelet count decreased | 3 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 platelet count decreased | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 thyroid stimulating hormone increased | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 weight gain | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 weight loss | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 weight loss | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 white blood cell decreased | 3 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 white blood cell decreased | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 anorexia | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 dehydration | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 dehydration | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypercalcemia | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hyperglycemia | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hyperkalemia | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypernatremia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 hypernatremia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypertriglyceridemia | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hyperuricemia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypoalbuminemia | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypocalcemia | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 hypocalcemia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypoglycemia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypokalemia | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 hypokalemia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypomagnesemia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 hypomagnesemia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hyponatremia | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypophosphatemia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 arthralgia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 generalized muscle weakness | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 muscle cramp | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 muscle soreness | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 myalgia | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 myositis | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 rhabdomyolysis | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 shoulder pain | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 dizziness | 4 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 dysgeusia | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 encephalopathy | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 headache | 4 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 jitters | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 memory impairment | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 syncope | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 tremors | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 agitation | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 altered mental state | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 depression | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 insomnia | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 mania | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 acute kidney injury | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 glucosuria | 3 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hematuria | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 proteinuria | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 urinary urgency | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 areola pain | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 breast edema | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 breast pain | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | grade 1-2 irregular menstruation | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 allergic rhinitis | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 cough | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 dyspnea | 4 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 epistaxis | 3 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 sore throat | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 alopecia | 4 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 dermatitis radiation | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 dry skin | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 flat, lacy rash | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hyperhidrosis | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 macular rash | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 palmar-plantar erythrodysesthesia syndrome | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 photosensitivity | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 pruritus | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 rash acneiform | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 thromboembolic event | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 rash maculo-papular | 3 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | 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 |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 skin ulceration | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hot flashes | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypertension | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 hypertension | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypotension | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 hypotension | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 thromboembolic event | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 anemia | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 lymph node pain | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 supraventricular tachycardia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 adrenal insufficiency | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 diabetes | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypoparathyroidism | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypothyroidism | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 blurred vision | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 eye pain | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 periorbital edema | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 periorbital edema | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 photophobia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 uveitis | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 watering eyes | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 constipation | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 diarrhea | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 dry mouth | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 dyspepsia | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 dysphagia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 gastroesophageal reflux disease | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 mucositis oral | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 nausea | 5 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 vomiting | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 vomiting | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 chills | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 edema limbs | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 edema trunk | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 fatigue | 6 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 fever | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 localized edema | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 neck edema | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 non-cardiac chest pain | 3 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 allergic reaction | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 bronchitis | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 cold symptoms | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 conjunctivitis | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 eye infection | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 folliculitis | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 sepsis | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 thrush | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 thrush | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 urinary tract infection | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 fall | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 infusion related reaction | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 seroma | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 alanine aminotransferase increased | 4 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 alkaline phosphtase increased | 3 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 aspartate aminotransferase increased | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 aspartate aminotransferase increased | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 blood lactate dehydrogenase increased | 4 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 cardiac troponin I increased | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 cardiac troponin T increased | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 cholesterol high | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 CPK increased | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 CPK increased | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 creatinine increased | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 creatinine increased | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 fibrinogen decreased | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 haptoglobin decreased | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 lipase increased | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 lymphocyte count decreased | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 lymphocyte count decreased | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 neutrophil count decreased | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 neutrophil count decreased | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 arthritis | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 back aches | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 back pain | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 back spasms | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 bilateral rib pain | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 bone pain | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 bone pain | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 generalized muscle weakness | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 peripheral motor neuropathy | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 peripheral sensory neuropathy | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 peripheral sensory neuropathy | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 productive cough | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 CPK increased | 4 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 anemia | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 skin ulceration | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 diarrhea | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 gastroesophageal reflux disease | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 cold symptoms | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 gas pain | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hot flashes | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 arthritis | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 flu like symptoms | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypertension | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 conjunctivitis | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 neutrophil count decreased | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 hypertension | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 platelet count decreased | 4 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 creatinine increased | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 platelet count decreased | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypotension | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 thyroid stimulating hormone increased | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 eye infection | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 weight gain | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 hypotension | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 weight loss | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 bone pain | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 weight loss | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 thromboembolic event | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 white blood cell decreased | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 folliculitis | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 white blood cell decreased | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 anemia | 4 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 anorexia | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 creatinine increased | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 dehydration | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 lymph node pain | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 dehydration | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 sepsis | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypercalcemia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 supraventricular tachycardia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hyperglycemia | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 back aches | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hyperkalemia | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 adrenal insufficiency | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypernatremia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 thrush | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 hypernatremia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 diabetes | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypertriglyceridemia | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 fibrinogen decreased | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hyperuricemia | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypoparathyroidism | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypoalbuminemia | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 thrush | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypocalcemia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypothyroidism | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 hypocalcemia | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 peripheral motor neuropathy | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypoglycemia | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 blurred vision | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypokalemia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 urinary tract infection | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 hypokalemia | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 eye pain | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypomagnesemia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 haptoglobin decreased | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 hypomagnesemia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 periorbital edema | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hyponatremia | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 fall | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hypophosphatemia | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 periorbital edema | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 generalized muscle weakness | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 INR increased | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 generalized muscle weakness | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 photophobia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 muscle cramp | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 infusion related reaction | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 muscle soreness | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 uveitis | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 myalgia | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 back pain | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 myositis | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 watering eyes | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 rhabdomyolysis | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 abdominal pain | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 shoulder pain | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 seroma | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 dizziness | 4 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 constipation | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 dysgeusia | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 lipase increased | 5 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 encephalopathy | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 alanine aminotransferase increased | 6 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 headache | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 dry mouth | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 jitters | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 edema limbs | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 memory impairment | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 peripheral sensory neuropathy | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 bone pain | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 syncope | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 dyspepsia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 tremors | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 alkaline phosphtase increased | 5 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 agitation | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 dysphagia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 altered mental state | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 lymphocyte count decreased | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 depression | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 gastrointestinal pain | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 insomnia | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 aspartate aminotransferase increased | 4 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 mania | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 mucositis oral | 5 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 acute kidney injury | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 back spasms | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 glucosuria | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 nausea | 5 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hematuria | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 aspartate aminotransferase increased | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 proteinuria | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 vomiting | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 urinary urgency | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 lymphocyte count decreased | 4 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 areola pain | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 vomiting | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 breast edema | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 blood lactate dehydrogenase increased | 6 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 breast pain | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 chills | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | grade 1-2 irregular menstruation | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 epistaxis | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 allergic rhinitis | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 cardiac troponin I increased | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 cough | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 edema trunk | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 dyspnea | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 neutrophil count decreased | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 productive cough | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 fatigue | 4 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 sore throat | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 cardiac troponin T increased | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 alopecia | 4 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 fever | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 dermatitis radiation | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 generalized body aches | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 dry skin | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 bilateral rib pain | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 flat, lacy rash | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 localized edema | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 hyperhidrosis | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 cholesterol high | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 macular rash | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 neck edema | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 palmar-plantar erythrodysesthesia syndrome | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 arthralgia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 photosensitivity | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 non-cardiac chest pain | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 pruritus | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 CPK increased | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 rash acneiform | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 allergic reaction | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 3-4 thromboembolic event | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 peripheral sensory neuropathy | 5 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 rash maculo-papular | 4 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 bronchitis | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only) | Grade 1-2 skin pain on chest and arms | 1 Participants |
Secondary
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)
Population: This outcome measure is only for Arm B as that arm is the only arm that received cabiralizumab.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events | Anemia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events | Periorbital edema | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events | Uveitis | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events | Thrush | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events | Aspartate aminotransferase increased | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events | CPK increased | 4 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events | Lymphocyte count decreased | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events | Neutrophil count decreased | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events | Platelet count decreased | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events | Weight gain | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events | Dehydration | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events | Hypocalcemia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events | Hypokalemia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events | Generalized muscle weakness | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events | Acute kidney injury | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events | Myositis | 2 Participants |
Secondary
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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Acute kidney injury | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | White blood cell decreased | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Hypocalcemia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Peripheral sensory neuropathy | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Dehydration | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Platelet count decreased | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Hypomagnesemia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Hypernatremia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Aspartate aminotransferase increased | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Sepsis | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Hypokalemia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Neutrophil count decreased | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Lymphocyte count decreased | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Anemia | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Hypotension | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Thrush | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Acute kidney injury | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Anemia | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Sepsis | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Thrush | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Aspartate aminotransferase increased | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Lymphocyte count decreased | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Platelet count decreased | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | White blood cell decreased | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Dehydration | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Hypernatremia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Hypocalcemia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Hypokalemia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Peripheral sensory neuropathy | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Hypotension | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Neutrophil count decreased | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Hypomagnesemia | 1 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Hypernatremia | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Peripheral sensory neuropathy | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Platelet count decreased | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Sepsis | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Acute kidney injury | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Lymphocyte count decreased | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Anemia | 1 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Hypotension | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Aspartate aminotransferase increased | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Hypomagnesemia | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Neutrophil count decreased | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Hypocalcemia | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Thrush | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Hypokalemia | 1 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | Dehydration | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events | White blood cell decreased | 0 Participants |
Secondary
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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Creatinine increased | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Thrush | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Dehydration | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Lymphocyte count decreased | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Anemia | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Weight gain | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Neutrophil count decreased | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Myositis | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Platelet count decreased | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Aspartate aminotransferase increased | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Hypocalcemia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Generalized muscle weakness | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | CPK increased | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Acute kidney injury | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Hypokalemia | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Acute kidney injury | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Hypocalcemia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Anemia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Thrush | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Aspartate aminotransferase increased | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | CPK increased | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Creatinine increased | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Lymphocyte count decreased | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Neutrophil count decreased | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Platelet count decreased | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Weight gain | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Dehydration | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Hypokalemia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Generalized muscle weakness | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Myositis | 2 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Creatinine increased | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Acute kidney injury | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Dehydration | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Hypocalcemia | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | CPK increased | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Myositis | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Hypokalemia | 1 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Aspartate aminotransferase increased | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Anemia | 1 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Neutrophil count decreased | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Generalized muscle weakness | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Platelet count decreased | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Lymphocyte count decreased | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Thrush | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events | Weight gain | 0 Participants |
Secondary
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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Hypokalemia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Weight gain | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Sepsis | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Anemia | 2 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | White blood cell decreased | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Acute kidney injury | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Hypocalcemia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Dehydration | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Aspartate aminotransferase increased | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Hypernatremia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Lymphocyte count decreased | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Peripheral sensory neuropathy | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Neutrophil count decreased | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Hypotension | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Hypomagnesemia | 0 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Platelet count decreased | 1 Participants |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Thrush | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Hypocalcemia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Anemia | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Sepsis | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Thrush | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Aspartate aminotransferase increased | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Neutrophil count decreased | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Platelet count decreased | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Weight gain | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | White blood cell decreased | 2 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Dehydration | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Hypernatremia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Hypokalemia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Hypomagnesemia | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Peripheral sensory neuropathy | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Acute kidney injury | 1 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Hypotension | 0 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Lymphocyte count decreased | 2 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Sepsis | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Hypokalemia | 1 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Neutrophil count decreased | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Lymphocyte count decreased | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Hypomagnesemia | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Aspartate aminotransferase increased | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Hypotension | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Peripheral sensory neuropathy | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Thrush | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Anemia | 1 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Dehydration | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Acute kidney injury | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Hypernatremia | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | White blood cell decreased | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Weight gain | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Hypocalcemia | 0 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Adverse Events Measured by Number of Participants With Paclitaxel Related Grade 3 or Higher Adverse Events | Platelet count decreased | 0 Participants |
Secondary
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | 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 |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | 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 |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Compare the Percent Change of Tumor Associated Macrophages (TAMs) Between Participants Who Achieve pCR Versus Those Who do Not | non-pCR | 82.8 percent change | — |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Compare the Percent Change of Tumor Associated Macrophages (TAMs) Between Participants Who Achieve pCR Versus Those Who do Not | pCR | -19.9 percent change | Standard Deviation 107 |
Secondary
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | 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 |
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | 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 |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Compare the Percent Change of Tumor Infiltrating Lymphocytes (TILs) Between Participants Who Achieve pCR Versus Those Who do Not | non-pCR | 32.2 percent change | — |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Compare the Percent Change of Tumor Infiltrating Lymphocytes (TILs) Between Participants Who Achieve pCR Versus Those Who do Not | pCR | -90.6 percent change | — |
Secondary
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)
Population: 1 participant in Arm A and 1 participant in Arm B did not have surgery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Pathological Complete Response (pCR) | 3 Participants |
| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | Pathological Complete Response (pCR) | 2 Participants |
| Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | Pathological Complete Response (pCR) | 2 Participants |
Secondary
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)