Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002)
3期
已完成
NCT03713593
| 适应症 | Carcinoma, Hepatocellular |
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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 | 794 人 |
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| 干预（药物） | lenvatinib, pembrolizumab, saline placebo |
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| 开始日期 | 2018年12月31日 |
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| 完成日期 | 2022年6月21日 |
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| 结果公布日 | 2023年7月24日 |
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摘要
The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants. The primary hypotheses of this study are that lenvatinib plus pembrolizumab is superior to lenvatinib plus placebo with respect to progression-free survival (PFS) and overall survival (OS).
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Up to approximately 41 months · Months
| Lenvatinib + Pembrolizumab | 8.2 Months |
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| Lenvatinib + Placebo | 8.1 Months |
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| Hazard Ratio (HR) | 0.834 (95% CI 0.712–0.978) |
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Overall Survival (OS)
Up to approximately 41 months · Months
| Lenvatinib + Pembrolizumab | 21.2 Months |
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| Lenvatinib + Placebo | 19.0 Months |
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| p-value | 0.0227 |
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| Hazard Ratio (HR) | 0.840 (95% CI 0.708–0.997) |
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