EACH
Research type
Research Study
Full title
A randomised phase II study evaluating the safety and anti-tumour activity of the combination of avelumab and cetuximab relative to avelumab monotherapy in recurrent/metastatic head and neck squamous cell cancer
IRAS ID
236581
Contact name
Martin Forster
Contact email
Sponsor organisation
University College London
Eudract number
2017-003592-64
Duration of Study in the UK
4 years, 5 months, 31 days
Research summary
Head & neck (H&N) cancer is the eighth most common cancer in the UK. Advanced H&N cancer which has come back after treatment or has spread to other parts of the body is incurable and the average life expectancy of these patients is less than a year. New drugs called immune checkpoint inhibitors work with the patient’s own immune system to fight cancer. They are used in the clinic to treat a number of cancers, including H&N cancer. It may be possible to make immune checkpoint inhibitors more effective by combining drugs that work in different ways. In effect, attacking the cancer from different angles. Cetuximab is a well-established drug that works by blocking signals that tell cancer cells to grow and divide into more cells. It also engages with the immune system within the tumour. We want to see if giving cetuximab along with an immune checkpoint inhibitor drug called avelumab is better at treating advanced H&N cancer than giving avelumab on its own.
These two drugs have not been given together before so to start with we plan to enrol a small number of patients and give them all avelumab + cetuximab to make sure the combination is safe at the doses we’ve chosen. After this, we plan to enrol 114 patients with advanced H&N cancer. Half the patients will be treated with avelumab alone and the other half with avelumab + cetuximab. Both drugs are given intravenously in the hospital once every 2 weeks. Treatment lasts for up to a year and patients will be followed up for up to 2 years from the time they enter the study. We will recruit patients from around 15 hospitals in the UK. We expect recruitment to start in the second quarter of 2018 and it will take about 18 months to recruit all the patients.REC name
London - City & East Research Ethics Committee
REC reference
18/LO/0021
Date of REC Opinion
16 Mar 2018
REC opinion
Further Information Favourable Opinion