MK-3475 in the Treatment of Recurrent/Metastatic Head and Neck Cancer
Research type
Research Study
Full title
A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.
IRAS ID
203679
Contact name
Kevin Harrington
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc.
Eudract number
2014-003698-41
Duration of Study in the UK
2 years, 0 months, 20 days
Research summary
Head and neck cancer describes a range of tumours that start in the head and neck area, which includes the cavity of the mouth and nose, pharynx, larynx, sinuses, thyroid, and salivary glands. Over half a million cases of head and neck cancer occur annually worldwide, making this the fifth most common cancer worldwide and accounting for 5% of all cancerous growths. Although the head and neck region contains many different structures and types of cells, most of the head and neck cancers start from the mucosa or lining of the upper respiratory and digestive tract and mainly begin in cells called squamous cells.
Programmed cell death 1 (PD1) is a protein present on the surface of immune (attacking) cells which fight cancer. When immune cells come upon 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 become exhausted or die thus stopping them from attacking the cancer. The study drug pembrolizumab has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.
This phase III study will last approximately 60 months and will recruit approximately 780 men and women over the age of 18. Patients may receive treatment for up to 24 months. The purpose of the study is to evaluate the safety and effectiveness of pembrolizumab versus pembrolizumab plus chemotherapy versus standard of care with cetuximab and chemotherapy. Subjects will be randomized 1:1:1 between the three arms of the trial.Prior to enrolling, patients will provide a tumour tissue sample, which will be tested for certain cancer markers.
The study is funded by Merck Sharp & Dohme Limited and will take place at 2 study centres in the UK.
REC name
London - Chelsea Research Ethics Committee
REC reference
16/LO/1133
Date of REC Opinion
25 Jul 2016
REC opinion
Favourable Opinion