Phase I Biomarker Study (BMS-936558)

An Exploratory Study to Investigate the Immunomodulatory Activity of Various Dose Levels of Anti Programmed-Death-1 (PD-1) Antibody (BMS-936558) in Subjects With Metastatic Clear Cell Renal Cell Carcinoma (RCC).

The purpose of this study is to evaluate the pharmacodynamic and biologic properties of BMS-936558 in subjects with metastatic renal cell carcinoma.

Intervention Model: Parallel Dose Comparison

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

Inclusion Criteria:

• Women and men ≥ 18 years of age.
• Histologic confirmation of renal cell carcinoma with a clear cell component.
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
• Tumor sites that can be accessed for repeat biopsies at acceptable clinical risk.
• Previously treated subjects must have failed at least 1 prior anti-angiogenic agent and can have a maximum of 3 prior systemic treatments for renal cell cancer.
• Subjects in the treatment naive arm cannot have received prior systemic therapy for their renal cell carcinoma.

Exclusion Criteria:

• Active or progressing brain metastases.
• Active concomitant.
• Active or history of autoimmune disease.
• Active use of systemic corticosteroids.
• Prior therapy with Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4), anti Programmed death-1 (anti-PD1), anti Programmed death ligand 1 (anti-PD-L1), anti Programmed death ligand 2 (anti-PD-L2), anti-CD137, anti-CD40, anti-OX40 antibodies.