Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
Phase 3
Active, not recruiting
NCT04223856
| Condition | Urothelial Cancer |
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| Phase | Phase 3 |
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| Sponsor | Astellas Pharma Global Development, Inc. |
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| Status | Active, not recruiting |
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| Enrollment | 886 participants |
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| Interventions | Enfortumab vedotin, Pembrolizumab, Cisplatin, Carboplatin, Gemcitabine |
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| Start date | Mar 30, 2020 |
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| Completion date | Aug 8, 2023 |
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| Results posted | Sep 27, 2024 |
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Summary
This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Blinded Independent Central Review (BICR)
From the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum exposure to treatment was up to 39.2 months) · Months
| Enfortumab Vedotin + Pembrolizumab | 12.5 Months |
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| Standard of Care | 6.3 Months |
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| p-value | <0.00001 |
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| Hazard Ratio (HR) | 0.450 (95% CI 0.377–0.538) |
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Overall Survival (OS)
From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum exposure to treatment was up to 39.2 months) · Months
| Enfortumab Vedotin + Pembrolizumab | 31.5 Months |
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| Standard of Care | 16.1 Months |
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| p-value | <0.00001 |
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| Hazard Ratio (HR) | 0.468 (95% CI 0.376–0.582) |
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Open in BENITIONS
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