CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 563 enrolled
Drug / intervention
pembrolizumab +3 moredrug
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.

Search/NCT04776148
NCT04776148Phase 3Completed

A Phase 3 Randomized Study of Lenvatinib in Combination With Pembrolizumab Versus Standard of Care in Participants With Metastatic Colorectal Cancer Who Have Received and Progressed On or After or Became Intolerant to Prior Treatment

Merck Sharp & Dohme LLC·interventional·Posted Mar 1, 2021·Updated Feb 5, 2026

In Brief

A Phase 3 clinical trial evaluating pembrolizumab, lenvatinib, and 2 other interventions for Colorectal Neoplasms. Completed, enrolled 563 participants across 95 sites in 15 countries.

Detailed Summary

The purpose of this study is to assess the safety and efficacy of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in participants with metastatic colorectal cancer. The study will also compare lenvatinib plus pembrolizumab with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil hydrochloride). The primary study hypothesis is that lenvatinib plus pembrolizumab is superior to standard of care with respect to overall survival.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Canada, China, Denmark, Germany, Israel, Japan, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
CollaboratorsEisai Inc.

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedMar 1, 2021
Enrollment StartMar 29, 2021
Primary CompletionSep 27, 2024
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 5.3 years ago

Interventions

pembrolizumabdrug

IV infusion

lenvatinibdrug

oral capsule

regorafenibdrug

oral tablet

TAS-102 (trifluridine and tipiracil)drug

oral tablet