An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer
Part of paid clinical trials in Anchorage, Alaska.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT02632409
- Phase
- PHASE3
- Status
- Active Not Recruiting
Conditions
- Various Advanced Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — BIOLOGICAL
- Placebo — OTHER
Study Details
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.
Key Dates
- Start date
- Mar 22, 2016
- Status verified
- Oct 2025
- Primary completion
- Jul 17, 2020
- Completion
- May 27, 2027
Study Design
- Enrollment
- 709 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: NivolumabNivolumab dose as specified
- Placebo Comparator: PlaceboPlacebo dose as specified
Primary Outcome Measure
Disease Free Survival (DFS) [ Time Frame: approximately up to 48 months ]