Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015)
3期
已完成
NCT04662710
| 适应症 | Advanced/Metastatic Gastroesophageal Adenocarcinoma |
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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 | 895 人 |
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| 干预（药物） | Pembrolizumab, Lenvatinib, Oxaliplatin, Capecitabine, Leucovorin (or Levoleucovorin) |
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| 开始日期 | 2020年12月30日 |
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| 完成日期 | 2024年10月29日 |
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| 结果公布日 | 2025年11月28日 |
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摘要
The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer. The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), in participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants.
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
Up to ~21 days · Participants
| Part 1 : Lenvatinib + Pembrolizumab + Chemotherapy | 2 Participants |
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Part 1: Number of Participants With Adverse Events (AEs)
Up to ~44 months · Participants
| Safety Run-In: Lenvatinib + Pembrolizumab + Chemotherapy | 15 Participants |
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Part 1: Number of Participants Who Discontinued Study Treatment Due to an AE
Up to ~29 months · Participants
| Safety Run-In: Lenvatinib + Pembrolizumab + Chemotherapy | 5 Participants |
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