BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)
- Conditions
- Renal Cell Carcinoma
- Interventions
- Biological: nivolumab
- Registration Number
- NCT01354431
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 168
- Histologic confirmation of Renal cell carcinoma (RCC) with a clear cell component
- Previous treatment with at least one anti-angiogenic agent
- Progressed within 6 months of study enrollment
- Subjects should not have had more than 3 prior treatments for locally advanced or metastatic disease
- Must have available tumor tissue for submission
- Subjects must also meet various laboratory parameters for inclusion
- Subjects with any active autoimmune disease or a history of known autoimmune disease
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: nivolumab - 0.3 mg/kg nivolumab - Arm 2: nivolumab - 2.0 mg/kg nivolumab - Arm 3: nivolumab - 10.0 mg/kg nivolumab -
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) From randomization to disease progression or death (up to approximately 2 years) 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.
- Secondary Outcome Measures
Name Time Method Number of Participants Experiencing Adverse Events From first dose to 30 days following last dose (up to approximately 6 years) 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 4.0Best Overall Response Rate (BORR) From randomization until disease progression or discontinuation of study therapy (up to approximately 2 years) 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 methodOverall Survival (OS) From randomization to to date of death (up to approximately 8 years) 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.
Trial Locations
- Locations (39)
Northwestern University Feinberg School Of Medicine
🇺🇸Chicago, Illinois, United States
University Of Maryland
🇺🇸Baltimore, Maryland, United States
North Mississippi Hematology And Oncology Associates, Ltd
🇺🇸Tupelo, Mississippi, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
The Bunting-Blaustein Cancer Research Building
🇺🇸Baltimore, Maryland, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Beth Israel Deaconess Medical Ctr.
🇺🇸Boston, Massachusetts, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Medical University Of South Carolina
🇺🇸Charleston, South Carolina, United States
Centre D'Oncologie Dr-Leon-Richard
🇨🇦Moncton, New Brunswick, Canada
University Of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Indiana University Health Melvin And Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Masonic Cancer Ctr, University Of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Tennessee Oncology, PLLC
🇺🇸Nashville, Tennessee, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Vanderbilt-Ingram Cancer Ctr
🇺🇸Nashville, Tennessee, United States
University of Washington - Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
University Of Colorado
🇺🇸Aurora, Colorado, United States
University Of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
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
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering Nassau
🇺🇸New York, New York, United States
St. Luke'S Roosevelt Hospital Center
🇺🇸New York, New York, United States
Blumenthal Cancer Center
🇺🇸Charlotte, North Carolina, United States
Wheaton Franciscan Health Care
🇺🇸Wauwatosa, Wisconsin, United States
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Local Institution
🇮🇹Siena, Italy
Centre Hospitalier Universitaire De Montreal-Notre-Dame Hosp
🇨🇦Montreal, Quebec, Canada
London Regional Cancer Program
🇨🇦London, Ontario, Canada
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University Of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States