CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
Lenvatinib +1 moredrug
Likely dose
Pembrolizumab 200 mgfrom 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.

Search/NCT03609359
NCT03609359Phase 2Completed
CompareCT.gov

An Open Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib With Pembrolizumab in Patients With Advanced Gastric Cancer

National Cancer Center Hospital East·interventional·Posted Aug 1, 2018·Updated Apr 16, 2025

In Brief

A Phase 2 clinical trial evaluating Lenvatinib and Pembrolizumab for Advanced Gastric Cancer. Completed, enrolled 29 participants across 1 site.

Detailed Summary

The efficacy and safety of the use of pembrolizumab in combination with lenvatinib.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Gastric Cancer
CountriesJapan
CollaboratorsMerck Sharp & Dohme LLC, Eisai Co., Ltd.

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 1, 2018
Enrollment StartOct 3, 2018
Primary CompletionApr 30, 2021
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.9 years ago

Interventions

Lenvatinibdrug

Lenvatinib will be administered with water orally once a day (with or without food) in 21-day cycles at approximately the same time each day. On Day 1 of each cycle, in case concomitantly administered, it will be administered approximately within 1 hour after completion of pembrolizumab administration.

Pembrolizumabdrug

Pembrolizumab will be administered as a dose of 200 mg as a 30-minute IV infusion, every 3 weeks (25 minutes to 40 minutes are acceptable).