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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01354431
Other study ID # CA209-010
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 31, 2011
Est. completion date April 15, 2021

Study information

Verified date May 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 168
Est. completion date April 15, 2021
Est. primary completion date May 15, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Subjects with any active autoimmune disease or a history of known autoimmune disease Other protocol-defined inclusion/exclusion criteria apply

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
nivolumab
Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
nivolumab
Solution, Intravenous (IV), 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
nivolumab
Solution, Intravenous (IV), 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons

Locations

Country Name City State
Canada Tom Baker Cancer Centre Calgary Alberta
Canada Local Institution Halifax Nova Scotia
Canada London Regional Cancer Program London Ontario
Canada Centre D'Oncologie Dr-Leon-Richard Moncton New Brunswick
Canada Centre Hospitalier Universitaire De Montreal-Notre-Dame Hosp Montreal Quebec
Finland Local Institution Helsinki
Italy Local Institution Siena
United States University Of Michigan Medical Center Ann Arbor Michigan
United States University Of Colorado Aurora Colorado
United States The Bunting-Blaustein Cancer Research Building Baltimore Maryland
United States University Of Maryland Baltimore Maryland
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Beth Israel Deaconess Medical Ctr. Boston Massachusetts
United States Roswell Park Cancer Institute Buffalo New York
United States Medical University Of South Carolina Charleston South Carolina
United States Blumenthal Cancer Center Charlotte North Carolina
United States Northwestern University Feinberg School Of Medicine Chicago Illinois
United States Cleveland Clinic Cleveland Ohio
United States Wayne State University Detroit Michigan
United States Duke University Medical Center Durham North Carolina
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 UCSD Moores Cancer Center La Jolla California
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Samuel Oschin Comprehensive Cancer Inst. Los Angeles California
United States Ucla Los Angeles California
United States Loyola University Medical Center Maywood Illinois
United States Masonic Cancer Ctr, University Of Minnesota Minneapolis Minnesota
United States Tennessee Oncology, PLLC Nashville Tennessee
United States Vanderbilt-Ingram Cancer Ctr Nashville Tennessee
United States Memorial Sloan Kettering Nassau New York New York
United States Mount Sinai Medical Center New York New York
United States St. Luke'S Roosevelt Hospital Center New York New York
United States Weill Cornell Medical College New York New York
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States University Of Pennsylvania Philadelphia Pennsylvania
United States University of Washington - Seattle Cancer Care Alliance Seattle Washington
United States Stanford Cancer Center Stanford California
United States North Mississippi Hematology And Oncology Associates, Ltd Tupelo Mississippi
United States Georgetown University Medical Center Washington District of Columbia
United States Wheaton Franciscan Health Care Wauwatosa Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
Bristol-Myers Squibb Ono Pharma USA Inc

Countries where clinical trial is conducted

United States,  Canada,  Finland,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From randomization to disease progression or death (up to approximately 2 years)
Secondary 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
From randomization until disease progression or discontinuation of study therapy (up to approximately 2 years)
Secondary 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.
From randomization to to date of death (up to approximately 8 years)
Secondary 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
From first dose to 30 days following last dose (up to approximately 6 years)
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