Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)
Condition: Advanced Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Nivolumab; Ipilimumab; Sunitinib
Intervention MeSH terms: Nivolumab; Ipilimumab; Sunitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1390.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the objective response rate, progression free
      survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib
      monotherapy in patients with previously untreated Renal Cell Cancer.
    

Eligibility criteria:

        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