The purpose of this study is to measure how active BMS-936558 (nivolumab) is against Renal Cell Carcinoma (RCC) as measured by the disease not progressing and whether a dose response relationship exists.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
168
Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
Solution, Intravenous (IV), 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
Solution, Intravenous (IV), 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
Progression Free Survival (PFS)
PFS is defined as the time from randomization to date of first disease progression (either clinical or radiographic progression, as assessed by the investigator). Tumor assessments (radiographic scans) were done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression. Survival was assessed every 3 months. The analysis of PFS was conducted after approximately 116 events (progression or death), approximately 2 years. PFS was calculated based on investigator's assessment of first date of progression (either clinical or radiographic progression) or date of death if progression did not occur. Progression was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions.
Time frame: From randomization to disease progression or death (up to approximately 2 years)
Best Overall Response Rate (BORR)
BORR is defined as the percentage of participants whose best response is either partial response (PR) or complete response (CR). Tumor response was evaluated by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 80% confidence interval is based on the Clopper and Pearson method
Time frame: From randomization until disease progression or discontinuation of study therapy (up to approximately 2 years)
Overall Survival (OS)
OS is defined as the time from date of randomization until date of death. If the participant did not die, overall survival will be censored on the last date the participant was known to be alive. Survival status is collected at each visit during treatment and every 3 months during follow-up. OS is based on Kaplan-Meier estimates.
Time frame: From randomization to to date of death (up to approximately 8 years)
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UCSD Moores Cancer Center
La Jolla, California, United States
Ucla
Los Angeles, California, United States
Samuel Oschin Comprehensive Cancer Inst.
Los Angeles, California, United States
Stanford Cancer Center
Stanford, California, United States
University Of Colorado
Aurora, Colorado, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Indiana University Health Melvin And Bren Simon Cancer Center
Indianapolis, Indiana, United States
University Of Kansas Medical Center
Kansas City, Kansas, United States
...and 31 more locations
Number of Participants Experiencing Adverse Events
Number of participants experiencing different types of events, including Adverse Events (AEs), Drug-related AEs, AEs leading to discontinuation, Drug-related AEs leading to discontinuation, Serious Adverse Events (SAEs), Drug-related SAEs. Events are classified based on the NCI Common Terminology Criteria (CTC) version 4.0
Time frame: From first dose to 30 days following last dose (up to approximately 6 years)