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)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 611 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors
• Triple Negative Breast Cancer
• Ovarian Cancer
• Gastric Cancer
• Colorectal Cancer
• Glioblastoma
• Biliary Tract Cancers
• Pancreatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Administered as an IV infusion on Day 1 Q3W.
DRUG	Lenvatinib	Administered orally once a day during each 21-day cycle.

Timeline

• Start date: 2019-02-12
• Primary completion: 2024-10-28
• Completion: 2024-10-28
• First posted: 2019-01-09
• Last updated: 2025-11-17
• Results posted: 2025-11-17

Locations

88 sites across 17 countries: United States, Argentina, Australia, Canada, Chile, Colombia, France, Germany, Israel, Italy, Russia, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study