Clinical Trial: NCT03797326
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)
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | Merck Sharp & Dohme LLC |
| Information Provided By: | Merck Sharp & Dohme LLC |
| Last Update Posted: | 2026-05-04 |
Study Overview
Brief Summary
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.
Official Title
A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005)
Conditions
Advanced Solid Tumors, Triple Negative Breast Cancer, Ovarian Cancer, Gastric Cancer, Colorectal Cancer, Glioblastoma, Biliary Tract Cancers, Pancreatic Cancer
Intervention / Treatment
- Biological: Pembrolizumab
- Drug: Lenvatinib
Other Study ID Numbers
- 7902-005
- MK-7902-005
- E7080-G000-224
- LEAP-005
- 2018-003747-37
- 2018
Start Date (Actual)
2019-02-12
Primary Completion Date (Actual)
2024-10-28
Study Completion Date (Actual)
2024-10-28
Enrollment (Actual)
611
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Merck Sharp & Dohme LLC |
| Information Provided By: | Merck Sharp & Dohme LLC |
| Last Update Posted: | 2026-05-04 |
Study Overview
Brief Summary
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.
Official Title
A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005)
Conditions
Advanced Solid Tumors, Triple Negative Breast Cancer, Ovarian Cancer, Gastric Cancer, Colorectal Cancer, Glioblastoma, Biliary Tract Cancers, Pancreatic Cancer
Intervention / Treatment
- Biological: Pembrolizumab
- Drug: Lenvatinib
Other Study ID Numbers
- 7902-005
- MK-7902-005
- E7080-G000-224
- LEAP-005
- 2018-003747-37
- 2018
Start Date (Actual)
2019-02-12
Primary Completion Date (Actual)
2024-10-28
Study Completion Date (Actual)
2024-10-28
Enrollment (Actual)
611
Study Type
Interventional
Phase
Phase 2