Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)
第2相
完了
NCT03797326
| 対象疾患 | Advanced Solid Tumors, Triple Negative Breast Cancer, Ovarian Cancer, Gastric Cancer |
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| 相 | 第2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 | 611 名 |
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| 介入（薬剤） | Pembrolizumab, Lenvatinib |
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| 開始日 | 2019年2月12日 |
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| 完了日 | 2024年10月28日 |
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| 結果公開日 | 2025年11月17日 |
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概要
The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer.
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator Assessment
Up to approximately 66 months · Percentage of Participants
| Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) | 22.6 Percentage of Participants |
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| Cohort B: Ovarian Cancer (Lenva + Pembro) | 25.8 Percentage of Participants |
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Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for Glioblastoma Multiforma [GBM] Only), by Blinded Independent Central Review (BICR)
Up to approximately 66 months · Percentage of Participants
| Cohort C: Gastric Cancer (Lenva + Pembro) | 15.2 Percentage of Participants |
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| Cohort D1: Colorectal Cancer (Lenva + Pembro) | 14.3 Percentage of Participants |
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| Cohort D2: Colorectal Cancer (Lenva) | 6.7 Percentage of Participants |
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| Cohort E: Glioblastoma Multiforma (Lenva + Pembro) | 21.8 Percentage of Participants |
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| Cohort F: Biliary Tract Cancer (Lenva + Pembro) | 17.6 Percentage of Participants |
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| Cohort G: Pancreatic Cancer (Lenva + Pembro) | 7.8 Percentage of Participants |
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Number of Participants With One or More Adverse Events (AEs)
Up to approximately 66 months · Participants
| Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) | 31 Participants |
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| Cohort B: Ovarian Cancer (Lenva + Pembro) | 31 Participants |
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| Cohort C: Gastric Cancer (Lenva + Pembro) | 97 Participants |
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| Cohort D1: Colorectal Cancer (Lenva + Pembro) | 104 Participants |
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| Cohort D2: Colorectal Cancer (Lenva) | 30 Participants |
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| Cohort E: Glioblastoma Multiforma (Lenva + Pembro) | 101 Participants |
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