Phase 3 study of pembrolizumab plus lenvatinib in EC
Research type
Research Study
Full title
A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001)
IRAS ID
268944
Contact name
Marcia Hall
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2018-003009-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 5 months, 0 days
Research summary
Endometrial cancer (EC) is the sixth most common cancer in women worldwide with approximately 320,000 new cases diagnosed in 2012. Most cases are detected at an early stage, however, approximately 13% of all EC cases recur and patients diagnosed with advanced or recurrent disease have a 5-year survival rate of 17%. This indicates an urgent need for exploration of more effective treatment options.
The current standard of treatment for EC is chemotherapy.
The study drug, 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.
Programmed cell death 1 (PD1) is a protein present on the surface of immune 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. Pembrolizumab has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.
Early studies show that the combination of lenvatinib and pembrolizumab can help increase the immune response against cancers cells, therefore could provide an effective treatment for EC.
This phase III study will last approximately 51 months and will recruit approximately 720 female participants aged ≥18 years with Stage III, Stage IV or recurrent EC. The study will compare the effectiveness and safety of lenvatinib in combination with pembrolizumab, versus chemotherapy (carboplatin and paclitaxel). Participants will be assigned randomly in a 1:1 ratio 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 seven study centres in the UK.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
19/NE/0269
Date of REC Opinion
17 Oct 2019
REC opinion
Favourable Opinion