POPPY
Research type
Research Study
Full title
A phase II trial to assess the efficacy and safety profile of pembrolizumab in patients with performance status 2 with recurrent or metastatic squamous cell carcinoma of the head and neck
IRAS ID
242511
Contact name
Martin Forster
Contact email
Sponsor organisation
University College London
Eudract number
2017-003636-36
Duration of Study in the UK
5 years, 0 months, 0 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. Many patients with Head and neck squamous cell carcinomas (HNSCC) have impaired performance status, excluding them from many new therapies.
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.
Trials evaluating pembrolizumab in HNSCC have demonstrated clinical activity in patients with recurrent and/or metastatic disease.The aim is to evaluate the safety and anti-tumour activity of pembrolizumab in patients with recurrent or metastatic Head and Neck Squamous Cell Cancer and a performance status of 2.
Treatment lasts for up to 24 months and patients will be followed up for up to 30 months from the time they start study treatment. We will recruit patients from up to 12 hospitals in the UK. We expect recruitment to start at the end of 2018 and it will take about 24 months to recruit all the patients.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0610
Date of REC Opinion
8 Jan 2019
REC opinion
Further Information Favourable Opinion