Pembrolizumab/Placebo Plus Trastuzumab Plus Chemo in HER2+ Gastric/GEJ
Research type
Research Study
Full title
A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo as First-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE 811)
IRAS ID
250170
Contact name
Kai-Keen Shiu
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2018-000224-34
Duration of Study in the UK
5 years, 3 months, 0 days
Research summary
Gastric (stomach) and gastroesophageal junction (GEJ)(lower oesophagus) cancer are a major health problem today, being the fifth most common cancer in the world. Worldwide in 2012, there are approximately one million new cases of gastric cancer with 723,000 deaths per year, making it the major cause of cancer-related deaths.
This clinical trial is trying to find out if chemotherapy, combined with targeted therapy (Trastuzumab) and an investigational immunotherapy (Pembrolizumab) can help stop or slow down advanced HER2 (human epidermal growth factor receptor 2) positive gastric or GEJ cancer. HER2 proteins are found on cancer cells that line the stomach. Trastuzumab is an antibody that targets the HER2 protein found on the surface of some tumours and blocks its function, stopping them from growing and killing them.
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 study is a phase 3 randomised, double-blind, clinical trial testing whether pembrolizumab (MK-3745) helps to stop or slow down cancer in patients with HER2+ advanced gastric or GEJ adenocarcinoma in comparison to placebo (dummy drug), when added to standard of care (trastuzumab plus chemotherapy). Approximately, 732 participants aged at least 18 years or above will be enrolled into this study.
The study is funded by Merck Sharp & Dohme Limited. It will take place at 8 study centres in the UK, and last for around 5 years.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
18/SC/0412
Date of REC Opinion
8 Oct 2018
REC opinion
Further Information Favourable Opinion