The purpose of this study is to evaluate the pharmacodynamic and biologic properties of BMS-936558 in subjects with metastatic renal cell carcinoma.
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).
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
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.
Active or progressing brain metastases.
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.
Ucsf Helen Diller Family Comprehensive Cancer Center San Francisco, California, 94115, USA
Yale University School Of Medicine New Haven, Connecticut, 06520, USA
H. Lee Moffitt Cancer Center Tampa, Florida, 33612, USA
University Of Chicago Medical Center Chicago, Illinois, 60637, USA
The Bunting-Blaustein Cancer Research Building Baltimore, Maryland, 21231, USA
Dana Farber Cancer Institute Boston, Massachusetts, 02215, USA
Dana Farber Cancer Inst Boston, Massachusetts, 02215, USA
Duke University Medical Center Durham, North Carolina, 27710, USA
Providence Portland Med Ctr Portland, Oregon, 97213, USA
Fox Chase Cancer Center Philadelphia, Pennsylvania, 19111, USA
Upmc Cancer Pavilion Pittsburgh, Pennsylvania, 15232, USA
University Of Wisconsin Carbone Cancer Center Madison, Wisconsin, 53705, USA