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)
Phase 3
Completed
NCT03713593
| Condition | Carcinoma, Hepatocellular |
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| Phase | Phase 3 |
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| Sponsor | Merck Sharp & Dohme LLC |
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| Status | Completed |
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| Enrollment | 794 participants |
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| Interventions | lenvatinib, pembrolizumab, saline placebo |
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| Start date | Dec 31, 2018 |
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| Completion date | Jun 21, 2022 |
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| Results posted | Jul 24, 2023 |
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Summary
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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