At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 611 enrolled
Drug / intervention
Pembrolizumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab and Lenvatinib for Advanced Solid Tumors and 7 related conditions. Completed, enrolled 611 participants across 88 sites in 17 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors, Triple Negative Breast Cancer, Ovarian Cancer, Gastric Cancer, Colorectal Cancer, Glioblastoma, Biliary Tract Cancers, Pancreatic Cancer
CountriesArgentina, Australia, Canada, Chile, Colombia, France, Germany, Israel, Italy, Russia, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, United States
CollaboratorsEisai Inc.
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJan 2019
Enrollment StartFeb 2019
Primary CompletionOct 2024
TodayJul 2026
First PostedJan 9, 2019
Enrollment StartFeb 12, 2019
Primary CompletionOct 28, 2024
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 7.5 years ago
Interventions
Pembrolizumabbiological
Administered as an IV infusion on Day 1 Q3W.
Lenvatinibdrug
Administered orally once a day during each 21-day cycle.