Ph3 Study of Lenvatinib + Pembrolizumab for 1L Therapy of Advanced HCC
Research type
Research Study
Full title
Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK- 7902) in Combination with Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants with Advanced Hepatocellular Carcinoma (LEAP-002)
IRAS ID
254915
Contact name
Daniel Palmer
Contact email
Sponsor organisation
Merck Sharp & Dohme (UK) Limited
Eudract number
2018-002983-26
Duration of Study in the UK
3 years, 8 months, 14 days
Research summary
Hepatocellular carcinoma (HCC) is one of the leading causes of cancer deaths worldwide, with incidence and mortality rates increasing. Patients with advanced HCC represent a group with high unmet need, low survival rates, few effective therapeutic options and poor health-related quality of life.
The current standard of treatment for advanced HCC is the drug, sorafenib. The study drug, lenvatinib, has been shown to be no less inferior to sorafenib in terms of overall survival and has already been approved for first-line treatment of advanced HCC. 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. Programmed cell death 1 (PD1) is a protein present on the surface of immune (attacking) cells which fight cancer. When immune cells meet cancer cells, PD1 becomes activated by programmed cell death ligands 1 and 2 (PDL1 and PDL2) which are proteins on the surface of cancer cells. The activated immune cells die thus stopping them from attacking the cancer.
Early studies show that the combination of lenvatinib and pembrolizumab can help increase the immune response against cancers cells and may provide a new treatment option for patients.
This phase III study will last approximately 3.5 years and will recruit approximately 750 participants aged ≥18 years with advanced HCC. The study will evaluate the effectiveness and safety of lenvatinib in combination with pembrolizumab, versus lenvatinib only. Participants will be assigned randomly to one of two groups of the study.
The study is sponsored by Merck Sharp & Dohme Limited (MSD), and co-funded by MSD and Eisai. It will take place at 6 study centres in UK.REC name
East Midlands - Derby Research Ethics Committee
REC reference
18/EM/0398
Date of REC Opinion
21 Jan 2019
REC opinion
Further Information Favourable Opinion