A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
Фаза 2
Идёт, набор закрыт
NCT04225117
| Заболевание | Locally Advanced or Metastatic Malignant Solid Tumors |
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| Фаза | Фаза 2 |
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| Спонсор | Astellas Pharma Global Development, Inc. |
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| Статус | Идёт, набор закрыт |
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| Участники | 329 участн. |
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| Вмешательство | enfortumab vedotin, pembrolizumab |
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| Дата начала | 10.03.2020 |
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| Дата завершения | 25.02.2025 |
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| Публикация результатов | 13.04.2026 |
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Кратко
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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