Pembrolizumab/placebo plus chemo as 1L therapy in HER2- Gastric/GEJ
Research type
Research Study
Full title
A Phase 3, randomized, double-blind clinical study of pembrolizumab (MK-3475) plus chemotherapy versus placebo plus chemotherapy as first-line treatment in participants with HER2 negative, previously untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma (KEYNOTE-859)
IRAS ID
251689
Contact name
Kai-Keen Shiu
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2018-001757-27
Duration of Study in the UK
5 years, 6 months, days
Research summary
Gastric (stomach) and gastro oesophageal junction (GEJ) cancer (cancer of the lower oesophagus) are a major health problem today, being the fifth most common cancer in the world. Worldwide in 2012, there are approximately 952,000 new cases of gastric cancer with 723,000 deaths per year, making it the third-leading cause of cancer-related deaths globally in both sexes.
This clinical trial is trying to determine if standard of care chemotherapy combined with an investigational immunotherapy (pembrolizumab) can help stop or slow down advanced gastric cancer or GEJ cancer. This study looks at how well a research study medication, pembrolizumab combined with chemotherapy, may work and how safe it is to take.
The immune system can detect and destroy cancer cells. One of the ways that tumour cells can avoid destruction is by increasing the amount of a protein called PDL1 (programmed cell death ligand 1) on its surface. When PDL1 interacts with a receptor called PD-1 on the surface of immune cells, the immune cell dies. Pembrolizumab (MK-3475) is a highly selective monoclonal antibody which binds to PD-1 and prevents PD-1/PDL1 interaction. This allows the immune system to increase the immune attack on the tumour.
This is a Phase 3, randomised, double-blind clinical study of pembrolizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment in participants with HER2 (human epidermal growth factor receptor 2) negative, previously untreated, unresectable or metastatic gastric or GEJ adenocarcinoma. Approximately, 780 male and female participants aged at least 18 years or above will be enrolled into this study. Participants will be eligible regardless of PD-L1 expression status to ensure inclusion of the entire spectrum of first-line gastric cancers.
The study is funded by Merck Sharp & Dohme Limited. It will take place at 4 study centres in the UK, and last for around 5.5 years.
REC name
London - Hampstead Research Ethics Committee
REC reference
18/LO/1854
Date of REC Opinion
22 Nov 2018
REC opinion
Favourable Opinion