Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
第3相
実施中（募集終了）
NCT04223856
| 対象疾患 | Urothelial Cancer |
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| 相 | 第3相 |
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| スポンサー | Astellas Pharma Global Development, Inc. |
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| ステータス | 実施中（募集終了） |
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| 参加者数 | 886 名 |
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| 介入（薬剤） | Enfortumab vedotin, Pembrolizumab, Cisplatin, Carboplatin, Gemcitabine |
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| 開始日 | 2020年3月30日 |
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| 完了日 | 2023年8月8日 |
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| 結果公開日 | 2024年9月27日 |
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概要
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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BENITIONS で見る
ClinicalTrials.gov の原文を見る
すべての治験
このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。