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
Фаза 3
Завершено
NCT02632409
| Заболевание | Various Advanced Cancer |
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| Фаза | Фаза 3 |
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| Спонсор | Bristol-Myers Squibb |
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| Статус | Завершено |
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| Участники | 709 участн. |
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| Вмешательство | Nivolumab |
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| Дата начала | 22.03.2016 |
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| Дата завершения | 17.07.2020 |
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| Публикация результатов | 1.12.2021 |
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Кратко
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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