CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 104 enrolled
Drug / intervention
lenvatinib +1 moredrug
Likely dose
pembrolizumab (200 mg)from 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/NCT03006926
NCT03006926Phase 1Completed
CompareCT.gov

An Open-Label Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Subjects With Hepatocellular Carcinoma

Eisai Co., Ltd.·interventional·Posted Dec 30, 2016·Updated Dec 13, 2023

In Brief

A Phase 1 clinical trial evaluating lenvatinib and pembrolizumab (200 mg) for Hepatocellular Carcinoma. Completed, enrolled 104 participants across 26 sites in 7 countries.

Detailed Summary

This is an open-label Phase 1b study designed to evaluate the tolerability and safety of lenvatinib in combination with pembrolizumab in participants with hepatocellular carcinoma (HCC). The study will evaluate objective response rate and duration of response by modified Response Evaluation Criteria In Solid Tumors (mRECIST) for HCC and Response Evaluation Criteria In Solid Tumors (RECIST 1.1) based on independent imaging review (IIR).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesFrance, Italy, Japan, Russia, Spain, United Kingdom, United States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 30, 2016
Enrollment StartFeb 13, 2017
Primary CompletionOct 31, 2019
Study CompletionNov 22, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.5 years ago

Interventions

lenvatinibdrug

4 mg capsules

pembrolizumab (200 mg)drug

30-minute intravenous infusion