The purpose of this study is to determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,844
Specified Dose on Specified Days
Specified Dose on Specified Days
Recurrence-free Survival (RFS) - All Randomized Participants
RFS was defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (from any cause), whichever occurred first. Median values based on Kaplan-Meier Estimates.
Time frame: From randomization to Primary Completion Date (up to approximately 3 years)
Recurrence-free Survival (RFS) - All Randomized Participants With PD-L1 Expression Level < 1%
RFS was defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (from any cause), whichever occurred first. Median based on Kaplan-Meier Estimates.
Time frame: From randomization to Primary Completion Date (up to approximately 3 years)
Overall Survival (OS) - All Randomized Participants
OS is defined as the time between the date of randomization and the date of death. Median based on Kaplan-Meier Estimates.
Time frame: From randomization to date of death (up to approximately 45 months)
Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1%
OS is defined as the time between the date of randomization and the date of death. Median based on Kaplan-Meier Estimates.
Time frame: From randomization to date of death (up to approximately 45 months)
Recurrence-free Survival (RFS) by Baseline Tumor PD-L1 Expression
RFS was defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (from any cause), whichever occurred first. Median based on Kaplan-Meier Estimates.
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University of Arizona Cancer Center
Tucson, Arizona, United States
The Angeles Clinic & Research Institute
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
University Of Colorado
Aurora, Colorado, United States
Georgetown University Med Ctr
Washington D.C., District of Columbia, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
UF Health Cancer Center at Orlando Health
Orlando, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute
Atlanta, Georgia, United States
University Of Chicago
Chicago, Illinois, United States
...and 114 more locations
Time frame: From randomization to Study Completion Date (up to approximately 45 months)
Time to Next-Line Therapies - All Randomized Participants
Time to next therapy was defined as the time from the date of randomization to the start date of next systemic therapy. Participants who did not receive next treatment were censored at the last known alive date. Time to second next therapy was defined as the time from the date of randomization to the start date of second next systemic therapy. Participants who did not receive second next treatment were censored at the last known alive date.
Time frame: From randomization to start of next therapy or second next therapy (up to approximately 45 months)
Time to Next-Line Therapies - All Randomized Participants With PD-L1 Expression Level < 1%
Time to next therapy was defined as the time from the date of randomization to the start date of next systemic therapy. Participants who did not receive next treatment were censored at the last known alive date. Time to second next therapy was defined as the time from the date of randomization to the start date of second next systemic therapy. Participants who did not receive second next treatment were censored at the last known alive date
Time frame: From randomization to start of next therapy or second next therapy (up to approximately 45 months)
Time From Next Therapy to Second Next Therapy - All Randomized Participants
Time from next treatment to second next treatment was defined as the time from the start date of next systemic therapy to start date of second next systemic therapy. No censoring rules were applied here as analysis was only performed for the subset of participants who received second next treatment.
Time frame: From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months)
Time From Next Therapy to Second Next Therapy - All Randomized Participants With PD-L1 Expression Level < 1%
Time from next treatment to second next treatment was defined as the time from the start date of next systemic therapy to start date of second next systemic therapy. No censoring rules were applied here as analysis was only performed for the subset of participants who received second next treatment.
Time frame: From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months)
Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants
PFS2 was defined as the time from randomization to the progression date on next-line systemic therapy or the end date of next-line systemic therapy (if progression date not available) or death from any cause (if both progression date and end date not available), and to last known alive date in case of no event (ie, censoring), meaning either (1) no subsequent systemic therapy and no death OR (2) subsequent systemic therapy but no progression date nor end date available and no death.
Time frame: From randomization to progression event (up to approximately 45 months)
Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants With PD-L1 Expression Level < 1%
PFS2 was defined as the time from randomization to the progression date on next-line systemic therapy or the end date of next-line systemic therapy (if progression date not available) or death from any cause (if both progression date and end date not available), and to last known alive date in case of no event (ie, censoring), meaning either (1) no subsequent systemic therapy and no death OR (2) subsequent systemic therapy but no progression date nor end date available and no death.
Time frame: From randomization to progression event (up to approximately 45 months)