Phase 3 Pembrolizumab+/-Lenvatinib First Line treatment in R/M HNSCC
Research type
Research Study
Full title
A Phase 3, randomized, placebo-controlled, double-blind clinical study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) to evaluate the safety and efficacy of pembrolizumab and lenvatinib as 1L intervention in a PD-L1 selected population of participants with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) (LEAP-010).
IRAS ID
277170
Contact name
Kevin Harrington
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2019-003717-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 8 days
Research summary
Head and neck cancers described a group of cancers that arise most often from the oral cavity, the throat and the larynx. More than 90% of head and neck cancers are squamous cell carcinomas (HNSCC), originating from the lining of the upper aerodigestive tract (combined organs and tissues of the respiratory tract and upper part of the digestive tract). Head and neck cancers are the 9th most common malignancy in the world with high mortality rates in developing countries.
Surgery and radiation therapy are markedly effective for patients with Stage I and II disease. However, despite intensive multimodal treatment, approximately 50-60% of patients with locally advanced Stage III or Stage IV HNSCC recur initially with localised disease. However, a significant proportion of these patients ultimately have incurable disease recurrence. The prognosis for patients with recurrent/metastatic (R/M, disease that has returned and/or spread) HNSCC is dismal and Overall Survival (OS) is less than 1 year.
Lenvatinib inhibits proteins involved in the formation of new blood vessels for tumours, thus preventing oxygen and nutrients getting to the tumour. Pembrolizumab blocks the Programmed Cell death 1 (PD1) protein and its ligand (PDL1 and PDL2) from binding, which causes the immune system to become activated and attack the cancer. Studies have shown that lenvatinib can also help increase the immune attack on cancers, which may result in a potent combination effect with PD-1/L1 signal inhibitors such as pembrolizumab.
This multicentre phase 3 study will recruit approximately 500 male and female (18+) participants. The purpose of this study is to assess the safety and efficacy of pembrolizumab and lenvatinib as a first line intervention in a PD-L1 selected population of participants with R/M HNCC.
The study is sponsored by Merck Sharp & Dohme Limited and will take place at 7 study centres in the UK.
REC name
London - Westminster Research Ethics Committee
REC reference
20/LO/0246
Date of REC Opinion
4 May 2020
REC opinion
Further Information Favourable Opinion