MK-3475 as neoadjuvant / adjuvant therapy in LA HNSCC
Research type
Research Study
Full title
A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for StageIII-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)
IRAS ID
236855
Contact name
Mary Lei
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2017-001139-38
Duration of Study in the UK
6 years, 1 months, 18 days
Research summary
Head and neck squamous cell carcinomas (HNSCC) describes a range of tumours, which most frequently occur in the mouth and throat region. Over 600,000 new cases of head and neck cancer occur annually worldwide, making it the seventh most common cancer in the world. Around 50% of head and neck squamous cell carcinomas are diagnosed at a locally advanced stage (where the cancer has spread adjacently). The 5-year survival rate for HNSCC remains low.
Programmed cell death 1 (PD1) is a protein present on the surface of immune (attacking) cells which fight cancer. When immune cells meet 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 7 years (1 year treatment; 6 years follow-up) and will recruit approximately 600 participants over the age of 18 with locally advanced HNSCC.
The purpose of the study is to evaluate the safety and effectiveness of pembrolizumab given as neoadjuvant therapy (before surgery), and as adjuvant therapy (after surgery) along with radiotherapy with/without cisplatin, versus no neoadjuvant therapy and only radiotherapy with/without cisplatin as adjuvant therapy. Participants will be assigned randomly in a 1:1 ratio to one of the two arms of trial. Participants may receive pembrolizumab treatment for up to 1 year.
The study is funded by Merck Sharp & Dohme Limited and will take place at five study centres in UK.
REC name
London - Chelsea Research Ethics Committee
REC reference
18/LO/0170
Date of REC Opinion
4 Apr 2018
REC opinion
Further Information Favourable Opinion