A Phase 1 Study of BMS-986015, an Anti-KIR Monoclonal Antibody, Administered With Ipilimumab, an Anti-CTLA4 Monoclonal Antibody, in Subjects With Select Advanced Solid Tumors

Inclusion Criteria:

- Histologic confirmation of one of the following solid tumors that is advanced
(unresectable or metastatic) for dose escalation or cohort expansion:Non-Small Cell
Lung Cancer (NSCLC), Castrate Resistant Prostate Cancer (CRPC), Melanoma (MEL)

- At least one measurable lesion at baseline by Computed tomography (CT) or Magnetic
resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST)
1.1 criteria

- Biopsies: Subjects in the melanoma cohort must have at least 1 tumor site that can be
biopsied at acceptable clinical risk

- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1

- Estimated life expectancy of ≥ 12 weeks

- White blood cell (WBC) ≥2000/μL, Neutrophils ≥1500/μL, Platelets ≥ 100x1000/μL,
Hemoglobin ≥ 8.5 g/dL, creatinine ≤ 1.5 X upper limit of normal (ULN) mL/min,
Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 3x ULN

Exclusion Criteria:

- Participation in any prior clinical study with BMS-936558 or ipilimumab that has
overall survival listed as a primary/co-primary endpoint

- Subjects with known or suspected brain metastasis

- Subjects with active autoimmune disease, uncontrolled or significant cardiovascular
disease

- Prior therapy with anti- Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) antibody or anti-
Killer cell immunoglobulin-like receptor (KIR) antibody