A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010) (KEYNOTE-010)
3期
已完成
NCT04199104
| 适应症 | Head and Neck Squamous Cell Carcinoma |
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| 分期 | 3期 |
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| 申办方 | Merck Sharp & Dohme LLC |
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| 状态 | 已完成 |
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| 受试者人数 | 511 人 |
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| 干预（药物） | Lenvatinib, Pembrolizumab |
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| 开始日期 | 2020年2月5日 |
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| 完成日期 | 2023年5月30日 |
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| 结果公布日 | 2024年7月16日 |
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摘要
This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma. Hypotheses include: * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR. * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).
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 ~ 37 months · Percentage of participants
| Pembrolizumab + Lenvatinib | 46.9 Percentage of participants |
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| Pembrolizumab + Placebo | 27.5 Percentage of participants |
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| p-value | 0.0000019 |
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| point estimate | 19.3 (95% CI 11.2–27.3) |
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Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR).
Up to ~ 37 months · Months
| Pembrolizumab + Lenvatinib | 7.0 Months |
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| Pembrolizumab + Placebo | 2.8 Months |
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| p-value | 0.0001129 |
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| Hazard Ratio (HR) | 0.68 (95% CI 0.55–0.83) |
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Overall Survival (OS)
Up to ~ 37 months · Months
| Pembrolizumab + Lenvatinib | 15.0 Months |
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| Pembrolizumab + Placebo | 17.9 Months |
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| p-value | 0.8819584 |
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| Hazard Ratio (HR) | 1.15 (95% CI 0.91–1.45) |
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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。