Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008).
2期
进行中(已停止招募)
NCT04895722
| 适应症 | Colorectal Cancer |
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| 分期 | 2期 |
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| 申办方 | Merck Sharp & Dohme LLC |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 302 人 |
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| 干预(药物) | Pembrolizumab, Pembrolizumab/Quavonlimab, Pembrolizumab/Favezelimab, Pembrolizumab/Vibostolimab, MK-4830 |
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| 开始日期 | 2021年6月25日 |
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| 完成日期 | 2025年5月21日 |
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| 结果公布日 | 2026年6月8日 |
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摘要
The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer.
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Up to approximately 46 months · Percentage of Participants
| Cohort A - Pembrolizumab/Quavonlimab | 45.0 Percentage of Participants |
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| Cohort A - Pembrolizumab | 29.5 Percentage of Participants |
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| Cohort B - Pembrolizumab/Quavonlimab | 46.2 Percentage of Participants |
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| Cohort B - Pembrolizumab Plus MK-4830 | 65.0 Percentage of Participants |
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| Cohort B - Pembrolizumab/Favezelimab | 37.5 Percentage of Participants |
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| Cohort B - Pembrolizumab/Vibostolimab | 48.8 Percentage of Participants |
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| Difference in Percentage | 15.6 (95% CI -1.7–32.1) |
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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。