A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
2期
进行中（已停止招募）
NCT04225117
| 适应症 | Locally Advanced or Metastatic Malignant Solid Tumors |
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| 分期 | 2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 | 329 人 |
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| 干预（药物） | enfortumab vedotin, pembrolizumab |
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| 开始日期 | 2020年3月10日 |
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| 完成日期 | 2025年2月25日 |
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| 结果公布日 | 2026年4月13日 |
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摘要
The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR) per RECIST v1.1. This study will also assess other measures of antitumor activity; overall survival (OS); as well as the safety and tolerability of enfortumab vedotin for cohorts 1 to 8 and enfortumab vedotin + pembrolizumab in cohort 9.
Cohorts 1-8: Confirmed Overall Response Rate (ORR) (Complete Response [CR] and Partial Response [PR]) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (V)1.1 Per Investigator Assessment
Up to 20.04 months · Percentage of participants
| Cohort 1: HR+/HER2- Breast Cancer | 15.6 Percentage of participants |
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| Cohort 2: TNBC Cancer | 19.0 Percentage of participants |
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| Cohort 3: Squamous NSCLC | 4.3 Percentage of participants |
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| Cohort 4: Non-squamous NSCLC | 16.3 Percentage of participants |
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| Cohort 5: Head and Neck Cancer | 23.9 Percentage of participants |
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| Cohort 7: EAC | 9.5 Percentage of participants |
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Cohort 9: Confirmed ORR (CR and PR) Per RECIST V1.1 Per Investigator Assessment
Up to 12.85 months · Percentage of participants
| Cohort 9: HNSCC | 39.0 Percentage of participants |
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