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)
Фаза 3
Завершено
NCT03713593
| Заболевание | Carcinoma, Hepatocellular |
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| Фаза | Фаза 3 |
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| Спонсор | Merck Sharp & Dohme LLC |
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| Статус | Завершено |
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| Участники | 794 участн. |
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| Вмешательство | lenvatinib, pembrolizumab, saline placebo |
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| Дата начала | 31.12.2018 |
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| Дата завершения | 21.06.2022 |
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| Публикация результатов | 24.07.2023 |
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Кратко
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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