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).
Intervention Model: Parallel Dose Comparison
For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.
Interventional
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Immunomodulatory activity as measured by the functional and phenotypic characterization of peripheral immune cells, modulation/changes in soluble factors, and the characterization of tumor immune infiltrates and the expression of tumor markers
Immunomodulation across the 4 treatment arms will be evaluated to explore these measures at multiple doses
Biomarker samples will be collected prior to the first study treatment through up to 24 weeks following initiation of study treatment
No
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Food and Drug Administration
CA209-009
NCT01358721
September 2011
August 2015
Name | Location |
---|---|
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
Duke University Medical Center | Durham, North Carolina 27710 |
University of Chicago Medical Center | Chicago, Illinois 60637 |
H Lee Moffitt Cancer Center | Tampa, Florida 33612 |
Yale University School Of Medicine | New Haven, Connecticut 06520 |
UPMC Cancer Pavilion | Pittsburgh, Pennsylvania 15232 |
Providence Portland Med Ctr | Portland, Oregon 97213 |
University of Wisconsin Carbone Cancer Center | Madison, Wisconsin 53792-5669 |
The Bunting-Blaustein Cancer Research Building | Baltimore, Maryland 21231 |
Dana Farber Cancer Inst | Boston, Massachusetts 02215 |