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)
2期
已完成
NCT03797326
| 适应症 | Advanced Solid Tumors, Triple Negative Breast Cancer, Ovarian Cancer, Gastric Cancer |
|---|
| 分期 | 2期 |
|---|
| 申办方 | Merck Sharp & Dohme LLC |
|---|
| 状态 | 已完成 |
|---|
| 受试者人数 | 611 人 |
|---|
| 干预（药物） | Pembrolizumab, Lenvatinib |
|---|
| 开始日期 | 2019年2月12日 |
|---|
| 完成日期 | 2024年10月28日 |
|---|
| 结果公布日 | 2025年11月17日 |
|---|
摘要
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 |
|---|
| Cohort B: Ovarian Cancer (Lenva + Pembro) | 25.8 Percentage of Participants |
|---|
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 |
|---|
| Cohort D1: Colorectal Cancer (Lenva + Pembro) | 14.3 Percentage of Participants |
|---|
| Cohort D2: Colorectal Cancer (Lenva) | 6.7 Percentage of Participants |
|---|
| Cohort E: Glioblastoma Multiforma (Lenva + Pembro) | 21.8 Percentage of Participants |
|---|
| Cohort F: Biliary Tract Cancer (Lenva + Pembro) | 17.6 Percentage of Participants |
|---|
| Cohort G: Pancreatic Cancer (Lenva + Pembro) | 7.8 Percentage of Participants |
|---|
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 |
|---|
| Cohort B: Ovarian Cancer (Lenva + Pembro) | 31 Participants |
|---|
| Cohort C: Gastric Cancer (Lenva + Pembro) | 97 Participants |
|---|
| Cohort D1: Colorectal Cancer (Lenva + Pembro) | 104 Participants |
|---|
| Cohort D2: Colorectal Cancer (Lenva) | 30 Participants |
|---|
| Cohort E: Glioblastoma Multiforma (Lenva + Pembro) | 101 Participants |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
全部试验
本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。