The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
701
Specified dose on specified day
Specified dose on specified days
Specified dose on specified days.
Progression Free Survival (PFS)
PFS is defined as the time from date of randomization to the first documented tumor progression date or death due to any cause, whichever occurs first based on BICR assessment using RECIST v1.1. Participants who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment on or prior to initiation of subsequent anti-cancer therapy. Progressive disease (PD); 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study
Time frame: From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months)
Overall Survival (OS)
Overall Survival is defined as the time between the date of randomization and the date of death due to any cause. For participants that are alive, their survival time will be censored at the date of last contact date (or "last known alive date").
Time frame: From randomization date to death date (Up to 31 months)
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the percentage of randomized participants who achieve a best response of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1 criteria) divided by the number of all randomized participants. Complete response (CR): Disappearance of all target lesions. Partial response (PR): 30% decrease in the sum of diameters of target lesions.
Time frame: Up to 31 Months
Number of Participants Experiencing Adverse Events (AEs)
Number of participants experiencing various types of any grade adverse events (AEs) during the specified time frame.
Time frame: From first dose to 100 days following last dose (Up to 32 Months)
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Specified dose on specified days
Local Institution - 0077
Daphne, Alabama, United States
Local Institution - 0044
Goodyear, Arizona, United States
Local Institution - 0132
Tucson, Arizona, United States
Local Institution - 0133
Bakersfield, California, United States
Local Institution - 0093
Los Angeles, California, United States
Local Institution - 0090
Redondo Beach, California, United States
Local Institution - 0088
San Luis Obispo, California, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, United States
Local Institution - 0103
Aurora, Colorado, United States
Local Institution - 0127
Athens, Georgia, United States
...and 125 more locations
Number of Participants Experiencing Serious Adverse Events (SAEs)
Number of participants experiencing various types of any grade serious adverse events (SAEs) during the specified time frame.
Time frame: From first to dose to 100 days following last dose (Up to 32 months)
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
Number of participants experiencing various types of any grade adverse events (AEs) leading to discontinuation during the specified time frame.
Time frame: From first dose to 30 days following last dose (Up to 30 months)
Number of Deaths
Number of deaths due to any cause during the specified time frame.
Time frame: From first dose to (up to 31 months) following first dose
Number of Participants With Laboratory Abnormalities
Number of participants experiencing laboratory abnormalities in hematology, serum chemistry and electrolytes with grade 3 or higher during the specified time frame.
Time frame: From first dose to 30 days following last dose (Up to 30 Months)
Number of Participants With Laboratory Values Grade Shifting From Baseline
Number of participants experiencing worsening shift from baseline in any grade and grade 3-4 of laboratory values during the specified time frame.
Time frame: From first dose to 30 days following last dose (Up to 30 Months)