A Phase III Study of Pembrolizumab vs. Chemotherapy in MSI-H or dMMR S
Research type
Research Study
Full title
A Phase III Study of Pembrolizumab (MK-3475) vs. Chemotherapy in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (KEYNOTE-177)
IRAS ID
194232
Contact name
Chie-Schin Shih
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2015-002024-89
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 0 days
Research summary
In the United States (US), colorectal cancers (CRC) are the third most commonly diagnosed cancer and the third leading cause of cancer death in both men and women. Approximately 4.5% of men and women will be diagnosed with colon and rectum cancer at some point during their lifetime.
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 programmed cell death ligand 2 (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 is a potent and highly selective humanised monoclonal antibody designed to block the PD-1/PDL1 and PDL2 interaction, thereby restoring the immune attack on cancers.
Approximately 270 male and female subjects over the age of 18 with MSI-H or dMMR will be enrolled into this Phase III study which will last approximately 36 months and take place at four sites in the UK - three hospitals and one research institute. The main purpose of the study is to compare progression free survival with Pembrolizumab monotherapy versus standard of care chemotherapy.
Subjects will be randomly assigned to one of two treatment groups, receiving either Pembrolizumab in three weekly dosing cycles or standard of care chemotherapy in two weekly cycles.
The study is funded by Merck Sharp & Dohme Limited.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
16/SC/0035
Date of REC Opinion
22 Mar 2016
REC opinion
Further Information Favourable Opinion