The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
794
Disease-free Survival (DFS)
Disease-free survival is defined as the time between randomization date and first date of recurrence or death, whichever occurs first. Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events. For participants who remained alive and without recurrence, DFS was censured on the date of last evaluable disease assessment
Time frame: From randomization to the date of recurrence or death (up to approximately 46 months)
Overall Survival (OS)
Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time was censored at the date of last contact date (or "last known alive date"). Overall survival was censored at the date of randomization for subjects who were randomized but had no follow-up.
Time frame: From randomization to the date of death (up to approximately 60 months)
Overall Survival Rates at 12-, 24-, and 36-months
Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following randomization
Time frame: At 12-, 24- and 36-months post first dose.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Local Institution - 0250
Tucson, Arizona, United States
Local Institution - 0026
Los Angeles, California, United States
Local Institution - 0023
San Francisco, California, United States
Local Institution - 0068
San Francisco, California, United States
Local Institution - 0151
Aurora, Colorado, United States
Local Institution - 0247
Denver, Colorado, United States
Local Institution - 0054
Washington D.C., District of Columbia, United States
Local Institution - 0113
Fort Myers, Florida, United States
Local Institution - 0131
Jacksonville, Florida, United States
Local Institution - 0226
Miami, Florida, United States
...and 194 more locations