Lenvatinib plus Pembrolizumab versus Standard of Care in 3L mCRC
Research type
Research Study
Full title
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
IRAS ID
1003543
Contact name
John F Norris
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2020-004289-20
Clinicaltrials.gov Identifier
Research summary
Research summary:
Colorectal cancer (CRC) is a serious, life-threatening condition. Worldwide, CRC is the second leading cause of cancer-related death with around 881,000 cancer-related deaths and a global incidence of around 1.8 million (approximately 10% of all cancers) in 2018. Despite improvements in treatment and earlier detection through screening, prognosis remains poor for patients with recurrent or distant disease; therefore, metastatic colorectal cancer (mCRC) continues to be a serious, life-threatening condition.
This trial is testing the safety and effectiveness of treatment with lenvatinib plus pembrolizumab in comparison to standard of care treatment (regorafenib or TAS-102) in participants with mCRC.
Lenvatinib and pembrolizumab have been approved to treat many cancer types. The lenvatinib plus pembrolizumab combination (trial drug combo) has not been approved to treat mCRC and is considered experimental.
Lenvatinib, works by blocking proteins called Vascular Endothelial Growth Factors which cancer cells can use to help themselves grow. Studies have shown that lenvatinib can also help increase the immune attack on cancers.
Pembrolizumab has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.This phase III study will last approximately 40 months and will recruit 434 male and female participants, aged 18 years and over with mCRC. Participants will be assigned randomly to one of two treatment groups and will receive study drugs for approximately 2 years or possibly longer. During this time, participants will visit the trial site about every 2 weeks. They will also have at least one telephone or virtual visit during this time.
The study is sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (“MSD”), and co-funded by MSD and Eisai. It will take place at 7 study centres in UK.
Summary of results:
https://clinicaltrials.gov/study/NCT04776148?term=MK-7902-017&rank=1&a=36&tab=results
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
21/YH/0024
Date of REC Opinion
23 Mar 2021
REC opinion
Further Information Favourable Opinion