The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.
The study has two primary endpoints. The first primary completion date is anticipated to be reached July 2022 (DFS in Part A). The second primary completion date is anticipated to be reached July 2024 (DFS in Part B).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,641
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Disease-Free Survival (DFS) by BICR - Treatment Part A and B
Disease-Free Survival (DFS) is defined as the time from randomization to development of local disease recurrence (ie, recurrence of primary tumor in situ or occurrence of a secondary renal cell carcinoma (RCC) primary cancer), distance metastasis, or death, whichever came first per Blinded Independent Central Review (BICR) based on Kaplan-Meier estimates.
Time frame: From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)
Overall Survival (OS) - Treatment Part A and B
Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the participants was known to be alive. Based on Kaplan-Meier estimates.
Time frame: From randomization to the date of death (up to approximately 72 months)
Overall Survival (OS) Rate (5 Years) - Treatment Part A and B
Overall survival rate at 5 years is defined as the percentage of participants who are alive at 5 years.
Time frame: At 5 years
Disease-Free Survival (DFS) Per BICR in Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B
Disease-Free Survival (DFS) is defined as the time from randomization to development of local disease recurrence (ie, recurrence of primary tumor in situ or occurrence of a secondary renal cell carcinoma (RCC) primary cancer), distance metastasis, or death, whichever came first per Blinded Independent Central Review (BICR) based on Kaplan-Meier estimates.
Time frame: From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)
Overall Survival (OS) in the Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B
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Specified dose on specified days
Local Institution - 0019
Birmingham, Alabama, United States
Local Institution - 0056
Springdale, Arkansas, United States
Local Institution - 0186
Los Angeles, California, United States
Local Institution - 0180
Los Angeles, California, United States
Local Institution - 0002
San Francisco, California, United States
Local Institution - 0185
Aurora, Colorado, United States
Local Institution - 0016
Athens, Georgia, United States
Local Institution - 0005
Chicago, Illinois, United States
Local Institution
Chicago, Illinois, United States
Local Institution - 0006
St Louis, Missouri, United States
...and 190 more locations
Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the participants was known to be alive. Based on Kaplan-Meier estimates
Time frame: From randomization to the date of death (up to approximately 72 months)
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Time frame: From first dose to 30 days post last dose (up to approximately 40 weeks)
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Time frame: From first dose to 30 days post last dose (up to approximately 40 weeks)
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Time frame: From first dose to 100 days post last dose (up to approximately 50 weeks)
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Time frame: From first dose to 100 days post last dose (up to approximately 50 weeks)
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A
Graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE, Version 4.0\] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment.
Time frame: From first dose to 30 days post last dose (up to approximately 40 weeks)
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B
Graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE, Version 4.0\] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment.
Time frame: From first dose to 30 days post last dose (up to approximately 40 weeks)
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A
Graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE, Version 4.0\] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment.
Time frame: From first dose to 100 days post last dose (up to approximately 50 weeks)
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B
Graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE, Version 4.0\] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment.
Time frame: From first dose to 100 days post last dose (up to approximately 50 weeks)