Pembrolizumab+epacadostat & EXTREME regimen 1st line Treat-R/M HNSCC
Research type
Research Study
Full title
A Phase 3 Randomized, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Pembrolizumab plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen as First line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)
IRAS ID
233885
Contact name
Kevin Harrington
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2017-001338-24
Duration of Study in the UK
4 years, 2 months, 0 days
Research summary
Head and neck squamous cell carcinomas (HNSCC) describes a range of tumours (cancers), they most frequently occur in the mouth and throat region. These cancers can have effects on basic functions like eating, swallowing, speaking and breathing.
The purpose of this study is to test two experimental drugs, alone and in combination. The drugs are pembrolizumab and epacadostat, and they will be tested in patients who have recurrent (has come back) or metastatic (has spread to other parts of the body) HNSCC.
Both pembrolizumab and epacadostat work by targeting proteins in the body that cancer cells use to escape the body’s immune system. It is hoped that the combination of pembrolizumab and epacadostat will improve the chances of the participant’s own immune system being able to shrink or destroy cancer cells.
This randomised, open-label Phase 3 study will test the safety, tolerability and effectiveness of the combination of pembrolizumab and epacadostat, compared to pembrolizumab alone, or compared to the standard of care “EXTREME” chemotherapy regimen - a combination of cetuximab, a platinum agent (cisplatin or carboplatin) and 5-fluorouracil.
Approximately 625 male/female participants aged ≥18 years will be enrolled; the trial will last approximately 50 months.
The study is co-funded by Incyte Corporation and Merck Sharp & Dohme Limited and will take place at 11 study centres in the UK.REC name
London - Central Research Ethics Committee
REC reference
17/LO/1929
Date of REC Opinion
5 Dec 2017
REC opinion
Favourable Opinion