KEYNOTE-158
Research type
Research Study
Full title
A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects with Advanced Solid Tumors (KEYNOTE 158)
IRAS ID
192537
Contact name
Juanita Lopez
Contact email
Eudract number
2015-002067-41
Duration of Study in the UK
5 years, 9 months, 1 days
Research summary
Programmed cell death 1 (PD1) is a protein present on the surface of immune cells which fight cancer. When immune cells encounter cancer cells, PD1 becomes activated by programmed cell death ligand 1 (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. Pembrolizumab is a potent & highly selective medication developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.
This study will measure the effectiveness of Pembrolizumab in treating particpants with any one of multiple types of advanced solid tumours (tumours which have spread and/or cannot be removed by surgery). The tumour types to be studied are all rare forms of cancer for which no effective treatment is currently available. The study will also measure whether certain biomarkers (indicators) in the tumour can make it more likely to respond to treatment with Pembrolizumab.
Between 100 and 1100 participants over the age of 18 with any one of 10 specified solid tumours will be enrolled into this Phase II study which will last approximately 5 years. Each participant will receive the study medication Pembrolizumab for approximately 2 years. In the UK, this study will take place at a single site.
The study is funded by Merck Sharp & Dohme Limited.
REC name
London - Riverside Research Ethics Committee
REC reference
15/LO/2073
Date of REC Opinion
5 Jan 2016
REC opinion
Further Information Favourable Opinion