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)
2상
완료
NCT03797326
| 대상 질환 | Advanced Solid Tumors, Triple Negative Breast Cancer, Ovarian Cancer, Gastric Cancer |
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| 임상 단계 | 2상 |
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| 스폰서 | Merck Sharp & Dohme LLC |
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| 상태 | 완료 |
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| 참여자 수 | 611 명 |
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| 중재(약물) | Pembrolizumab, Lenvatinib |
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| 시작일 | 2019년 2월 12일 |
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| 완료일 | 2024년 10월 28일 |
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| 결과 공개일 | 2025년 11월 17일 |
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요약
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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