The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
709
Disease Free Survival (DFS)
The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Time frame: approximately up to 48 months
Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population
The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Time frame: approximately up to 48 months
Non-Urothelial Tract Recurrence Free Survival
The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Time frame: up to 53 months
Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression ≥ 1% Population
The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Time frame: up to 53 months
Overall Survival
the time from randomization to the date of death from any cause.
Time frame: on going
Overall Survival in Participants With PD-L1 Expression ≥ 1%
the time from randomization to the date of death from any cause.
Time frame: on going
Disease Specific Survival
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Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska, United States
Local Institution - 0179
Tucson, Arizona, United States
Local Institution - 0061
Clovis, California, United States
Local Institution - 0172
Sacramento, California, United States
Local Institution - 0005
San Francisco, California, United States
Local Institution - 0178
Lakewood, Colorado, United States
Local Institution - 0167
Gainesville, Florida, United States
Local Institution - 0030
Miami Beach, Florida, United States
Local Institution - 0008
Tampa, Florida, United States
Local Institution - 0168
Maywood, Illinois, United States
...and 178 more locations
the time from randomization to the date of death due to disease (urothelial cancer).
Time frame: on going
Disease Specific Survival in Participants With PD-L1 Expression ≥ 1%
the time from randomization to the date of death due to disease (urothelial cancer).
Time frame: on going