Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
3期
进行中（已停止招募）
NCT04223856
| 适应症 | Urothelial Cancer |
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| 分期 | 3期 |
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| 申办方 | Astellas Pharma Global Development, Inc. |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 886 人 |
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| 干预（药物） | Enfortumab vedotin, Pembrolizumab, Cisplatin, Carboplatin, Gemcitabine |
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| 开始日期 | 2020年3月30日 |
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| 完成日期 | 2023年8月8日 |
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| 结果公布日 | 2024年9月27日 |
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摘要
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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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。