Clinical Trial Details
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NCT02982954 : A Study to Evaluate the Safety of Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Cancer
PhasePhase 4
AgesMin: 18 Years Max: N/A
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please

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

Exclusion Criteria:

1. Medical Conditions

1. Subjects with any active autoimmune disease or a history of known autoimmune

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

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 could apply
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