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/LEAP-010)-China Extension
3期
已完成
NCT05523323
| 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 | 112 人 |
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| 干预（药物） | Lenvatinib, Pembrolizumab |
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| 开始日期 | 2020年10月30日 |
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| 完成日期 | 2023年8月25日 |
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| 结果公布日 | 2024年10月18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 approximately 33 months · Percentage of participants
| Pembrolizumab + Lenvatinib | 39.3 Percentage of participants |
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| Pembrolizumab + Placebo | 9.8 Percentage of participants |
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| p-value | 0.0002014 |
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| Estimate difference | 29.5 (95% CI 14.0–43.9) |
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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 approximately 33 months · Months
| Pembrolizumab + Lenvatinib | 7.0 Months |
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| Pembrolizumab + Placebo | 1.5 Months |
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| p-value | 0.0000037 |
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| Hazard Ratio (HR) | 0.34 (95% CI 0.21–0.55) |
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Overall Survival (OS)
Up to approximately 33 months · Months
| Pembrolizumab + Lenvatinib | 10.9 Months |
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| Pembrolizumab + Placebo | 11.9 Months |
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| p-value | 0.30933 |
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| Hazard Ratio (HR) | 0.86 (95% CI 0.49–1.54) |
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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。