A Study to Evaluate the Safety of Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Cancer
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma, Renal Cell
Intervention: Nivolumab; Ipilimumab
Intervention description: Specified dose on specified day; Specified Dose on Specified Day
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 211.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with
      previously untreated advanced or metastatic Renal Cell Cancer.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Type of Participant and Target Disease Characteristics

          1. Advanced or metastatic RCC

          2. Histologically confirmed, previously untreated (treatment-naive) RCC

          3. No prior systemic therapy for RCC except for one prior adjuvant or neoadjuvant therapy
             for completely resectable RCC

          4. Measurable disease as per RECIST 1.1. Subject must have extracranial metastasis as
             measurable disease

          5. Karnofsky Performance Status (KPS) of at least 70% for Cohort 1, 2, and 3; KPS of
             50-60% for Cohort 4

          6. Tumor tissue need be received by the central vendor (block or unstained slides). Note:
             Fine Needle Aspiration (FNA)and bone metastases samples are not acceptable for
             submission.

        Exclusion Criteria:

          1. Medical Conditions

               1. Subjects with any active autoimmune disease or a history of known autoimmune
                  disease

               2. Prior malignancy active within the previous 3 years except for locally curable
                  cancers that have been apparently cured

               3. Known HIV or AIDS-related illness

               4. Any positive test for hepatitis B or hepatitis C virus indicating acute or
                  chronic infection.

          2. Prior/Concomitant Therapy

               1. Prior systemic treatment in the metastatic setting with Vascular epithelial
                  growth factor(VEGF) or VEGF receptor targeted therapy

               2. Prior treatment with an anti-Programmed Death (PD) -1, anti-PD-L1, anti-PD-L2,
                  anti-cluster of differentiation 137 (CD137), or anti-cytotoxic
                  T-lymphocyte-associated antigen 4(CTLA-4) antibody, or any other antibody or drug
                  specifically targeting T-cell co-stimulation or checkpoint pathways. This
                  includes the utilization of these agents in the neo-adjuvant or adjuvant setting.

               3. Anti-cancer therapy less than 28 days prior to the first dose of study drug or
                  palliative, focal radiation therapy less than 14 days prior to the first dose of
                  study drug.

        Other protocol defined inclusion/exclusion criteria apply