The PEACH Study
Research type
Research Study
Full title
Phase I dose-escalation study of PEmbrolizumab (MK3475) Anti-PD1 immune checkpoint inhibitor combined with radical Chemoradiotherapy in patients with stage IV squamous cell carcinoma of the Head and neck.
IRAS ID
179960
Contact name
Kevin Harrington
Contact email
Sponsor organisation
Royal Marsden NHS Foundation Trust
Eudract number
2015-001095-21
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Patients with advanced, stage IV head and neck cancers are usually treated with a combination of radiotherapy and chemotherapy in an attempt to cure their disease. Treatment outcomes depends on a number of factors, including the site in which the tumour has arisen, the presence or absence of infection with human papillomavirus (HPV) and whether, or not, the patient has been a cigarette smoker. Using these factors, we can define patients with stage IV head and neck cancer in whom standard chemoradiotherapy may fail to control their disease. Therefore, in this research protocol we will treat patients with either HPV-negative or HPV-positive disease who are at relatively high risk (30-70%) of developing recurrent disease after standard chemoradiotherapy. The research involves adding a new therapy in the form of an anti-PD1 monoclonal antibody (pembrolizumab) to the standard treatment of radiotherapy combined with cisplatin/carboplatin chemotherapy. This treatment seeks to activate the patient’s own immune system to attack the cancer cells – and we believe that adding this treatment during chemoradiotherapy may be particularly effective. Patients will receive an initial dose of pembrolizumab 2 weeks before starting a 7-week course of chemoradiotherapy. In the first instance, patients will receive 100 mg of pembrolizumab and, if this is safe and tolerable in the first 3 patients, the dose will be increased to 200 mg for all other patients. Radiation will be delivered on 35 occasions with chemotherapy given intravenously in weeks 1, 4 and 7. Additional doses of pembrolizumab will be given every 3 weeks for a further 7 doses (3 during and 4 after chemoradiotherapy). Patients will be divided into 2 separate groups according to the HPV status in their tumours. We will assess the safety and tolerability of the combination of pembrolizumab and chemoradiotherapy and also document the effectiveness of this treatment.
REC name
London - Riverside Research Ethics Committee
REC reference
16/LO/1175
Date of REC Opinion
18 Jul 2016
REC opinion
Favourable Opinion