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
Phase 3
Completed
NCT02632409
| Condition | Various Advanced Cancer |
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| Phase | Phase 3 |
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| Sponsor | Bristol-Myers Squibb |
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| Status | Completed |
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| Enrollment | 709 participants |
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| Interventions | Nivolumab |
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| Start date | Mar 22, 2016 |
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| Completion date | Jul 17, 2020 |
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| Results posted | Dec 1, 2021 |
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Summary
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.
Disease Free Survival (DFS)
approximately up to 48 months · Months
| Placebo | 10.84 Months |
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| Nivolumab | 20.76 Months |
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| p-value | 0.0008 |
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| Hazard Ratio (HR) | 0.70 (95% CI 0.55–0.90) |
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Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population
approximately up to 48 months · Months
| Placebo | 8.41 Months |
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| Nivolumab | NA Months |
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| p-value | 0.0005 |
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| Hazard Ratio (HR) | 0.54 (95% CI 0.35–0.84) |
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Open in BENITIONS
View on ClinicalTrials.gov
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