Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Histological confirmation of renal cell carcinoma (RCC) with a clear-cell component

- Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC
Stage IV) RCC

- No prior systemic therapy for RCC with the following exception:

1. One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such
therapy did not include an agent that targets vascular endothelial growth factor
(VEGF) or VEGF receptors and if recurrence occurred at least 6 months after the
last dose of adjuvant or neoadjuvant therapy

- Karnofsky Performance Status (KPS) of at least 70%

- Measurable disease as per Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1

- Tumor tissue [formalin-fixed paraffin-embedded (FFPE) archival or recent
acquisition] must be received by the central vendor (block or unstained
slides) in order to randomize a subject to study treatment. (Note: Fine
Needle Aspiration [FNA] and bone metastases samples are not acceptable for
submission)

Exclusion Criteria:

- Any history of or current central nervous system (CNS) metastases. Baseline imaging of
the brain is required within 28 days prior to randomization

- Prior systemic treatment with VEGF or VEGF receptor targeted therapy (including, but
not limited to, Sunitinib, Pazopanib, Axitinib, Tivozanib, and Bevacizumab)

- Prior treatment with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD-L2,
anti-CD137, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other
antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

- Any active or recent history of a known or suspected autoimmune disease or recent
history of a syndrome that required systemic corticosteroids (>10 mg daily Prednisone
equivalent) or immunosuppressive medications except for syndromes which would not be
expected to recur in the absence of an external trigger. Subjects with vitiligo or
type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only
requiring hormone replacement are permitted to enroll

- Any condition requiring systemic treatment with corticosteroids (>10 mg daily
Prednisone equivalents) or other immunosuppressive medications within 14 days prior to
first dose of study drug. Inhaled steroids and adrenal replacement steroid doses >10
mg daily Prednisone equivalents are permitted in the absence of active autoimmune
disease