NCT04776148

Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 563 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Global portion, or Global Cohort, will include all participants who are enrolled during the Global enrollment period and will be the primary analysis population for the study. After enrollment of the global portion of the study is complete, the study will remain open to enrollment in China alone until the target number of participants from China have been enrolled to meet local regulatory requirements. The China Cohort will include both participants enrolled in China for the Global Cohort plus those participants enrolled in China as part of the China extension enrollment period. Per the supplemental Statistical Analysis Plan (sSAP), China participants randomized after the enrollment of the global portion is closed as part of the China extension enrollment period will not be included in the global analysis populations. As pre-specified in the protocol, safety and efficacy outcome measures for the China Cohort will be analyzed separately from the Global Cohort.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
DRUG	pembrolizumab	IV infusion
DRUG	lenvatinib	oral capsule
DRUG	regorafenib	oral tablet
DRUG	TAS-102 (trifluridine and tipiracil)	oral tablet

Timeline

• Start date: 2021-03-29
• Primary completion: 2024-09-27
• Completion: 2024-09-27
• First posted: 2021-03-01
• Last updated: 2026-02-05
• Results posted: 2024-04-09

Locations

95 sites across 15 countries: United States, Argentina, Australia, Canada, China, Denmark, Germany, Israel, Japan, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study