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)
第3相
完了
NCT03713593
| 対象疾患 | Carcinoma, Hepatocellular |
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| 相 | 第3相 |
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| スポンサー | Merck Sharp & Dohme LLC |
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| ステータス | 完了 |
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| 参加者数 | 794 名 |
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| 介入（薬剤） | lenvatinib, pembrolizumab, saline placebo |
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| 開始日 | 2018年12月31日 |
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| 完了日 | 2022年6月21日 |
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| 結果公開日 | 2023年7月24日 |
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概要
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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BENITIONS で見る
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すべての治験
このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。