Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advance Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)
3期
已完成
NCT03820986
| 适应症 | Malignant Melanoma |
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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 | 674 人 |
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| 干预（药物） | Pembrolizumab, Lenvatinib, Placebo for lenvatinib |
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| 开始日期 | 2019年3月12日 |
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| 完成日期 | 2023年1月18日 |
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| 结果公布日 | 2024年1月17日 |
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摘要
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line treatment in adults with no prior systemic therapy for their advanced melanoma. The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Overall Survival (OS). For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Up to approximately 34 months · Months
| Pembrolizumab+Lenvatinib | 9.1 Months |
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| Pembrolizumab+Placebo | 4.2 Months |
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| p-value | 0.0176 |
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| Hazard Ratio (HR) | 0.81 (95% CI 0.67–0.98) |
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Overall Survival (OS)
Up to approximately 46 months · Months
| Pembrolizumab+Lenvatinib | 25.8 Months |
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| Pembrolizumab+Placebo | 39.5 Months |
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| p-value | 0.9521 |
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| Hazard Ratio (HR) | 1.20 (95% CI 0.97–1.48) |
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