Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)

The purpose of this study is to determine whether the addition of nivolumab to chemotherapy
improves pathologic complete response (pCR) in the breast and post-therapy lymph nodes
evaluated histologically (ypT0/Tis ypN0) in patients with inflammatory breast cancer (IBC).

Inclusion Criteria:

- Newly diagnosed inflammatory breast cancer without distant metastases and have not
received prior chemotherapy or immunotherapy. All breast cancer subtypes are allowed:
Triple negative breast cancer (TNBC); Hormone receptor (HR)-positive and human
epidermal growth factor receptor 2 (HER2)-negative; HR-positive or HR-negative and
HER2-positive

Exclusion Criteria:

- Clinical or radiologic evidence of distant metastases

- Malignancy that progressed within the last five years.

- Cardiac disease (history of and/or active disease)

- HIV positive

- Neuropathy ≥ Grade 2, per the NCI CTCAE v5.0

- Allogeneic stem cell or solid organ transplantation

- Autoimmune disease where in the opinion of the Investigator would preclude the use of
immunotherapy

- Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans),
or evidence of active pneumonitis

- Tuberculosis

- Pregnancy or lactation

- Treatment with CD137 agonists or immune checkpoint−blockade therapies, including
anti-CD40, anti−CTLA-4, anti−PD-1, and anti−PD-L1 therapeutic antibodies

- Treatment with systemic immunosuppressive medications

- Cardiopulmonary dysfunction

- Clinically significant history of liver disease, including cirrhosis, autoimmune
hepatic disorders, HIV infection, or active Hepatitis B or Hepatitis C

- Subject is pregnant or nursing

- Known hypersensitivity to the components of the study drugs(s)