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

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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