A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)
Phase 2
Active, not recruiting
NCT03459846
| Condition | Urinary Bladder Neoplasms |
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| Phase | Phase 2 |
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| Sponsor | AstraZeneca |
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| Status | Active, not recruiting |
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| Enrollment | 154 participants |
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| Interventions | Durvalumab, Olaparib |
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| Start date | Mar 16, 2018 |
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| Completion date | Oct 15, 2020 |
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| Results posted | Oct 26, 2022 |
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Summary
A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in Platinum-Ineligible Patients With Unresectable Stage IV Urothelial Cancer
Progression-free Survival (PFS)
Assessments performed at baseline and every 8 weeks from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), assessed up to the data cut-off date (15 Oct 2020), up to a max. of 31 months · Months
| Durva + Olaparib | 4.2 Months |
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| Durva + Placebo | 3.5 Months |
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| p-value | 0.789 |
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| Hazard Ratio (HR) | 0.94 (95% CI 0.641–1.387) |
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Open in BENITIONS
View on ClinicalTrials.gov
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