The purpose of this study is to test the effectiveness and safety of nivolumab combined with ipilimumab compared to nivolumab monotherapy in participants with previously untreated kidney cancer that has spread.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
437
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Progression free survival (PFS) by blinded independent central review (BICR)
Time frame: Up to 34 months
Objective response rate (ORR) by BICR
Time frame: Up to 23 months
Overall survival (OS)
Time frame: Up to 4 years
Overall response rate (ORR) by investigator
Time frame: Up to 4 years
Disease control rate (DCR) by investigator
Time frame: Up to 4 years
Duration of response (DoR) by investigator
Time frame: Up to 4 years
Time to objective response (TTR) by investigator
Time frame: Up to 4 years
Progression Free Survival (PFS) by investigator
Time frame: Up to 4 years
Progression free survival secondary objective (PFS2) by investigator
Time frame: Up to 4 years
Disease control rate (DCR) by BICR
Time frame: Up to 4 years
Duration of response (DoR) by BICR
Time frame: Up to 4 years
Time to objective response (TTR) by BICR
Time frame: Up to 4 years
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Local Institution - 0013
Washington D.C., District of Columbia, United States
Local Institution - 0053
Athens, Georgia, United States
Local Institution - 0066
Boston, Massachusetts, United States
Local Institution - 0088
Boston, Massachusetts, United States
Local Institution - 0086
Boston, Massachusetts, United States
The Reading Hosp Med Ctr Reg Cancer Ctr
West Reading, Pennsylvania, United States
Local Institution - 0084
Charleston, South Carolina, United States
Local Institution - 0100
Capital Federal, Buenos Aires, Argentina
Local Institution - 0011
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0060
Mar del Plata, Buenos Aires, Argentina
...and 68 more locations
Incidence of Adverse Events (AEs)
Time frame: Up to 4 years
Incidence of drug-related AEs
Time frame: Up to 4 years
Incidence of Severe Adverse Events (SAEs)
Time frame: Up to 4 years
Incidence of drug-related SAEs
Time frame: Up to 4 years
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to 4 years
Incidence of clinically significant changes in clinical laboratory results: Coagulation tests
Time frame: Up to 4 years
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame: Up to 4 years
Incidence of clinically significant changes in clinical laboratory results: Serology tests
Time frame: Up to 4 years
PFS based on gene expression (GEP) signatures
Time frame: Up to 4 years
Objective response rate (ORR) based on GEP signatures
Time frame: Up to 4 years
OS based on GEP signatures
Time frame: Up to 4 years
OS based on programmed cell death protein ligand-1 (PD-L1) expression
Time frame: Up to 4 years
ORR by BICR based on PD-L1 expression
Time frame: Up to 4 years
PFS by BICR based on PD-L1 expression
Time frame: Up to 4 years