NAC/Adj GEJ Adenocarcinoma with Chemo (XP/FP) vs Chemo + Pembro Study
Research type
Research Study
Full title
A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) plus Chemotherapy (XP or FP) versus Placebo plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects with Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585)
IRAS ID
229278
Contact name
Ian Chau
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2016-004408-76
Duration of Study in the UK
5 years, 10 months, 22 days
Research summary
Gastric (stomach) and gastroesophageal (intersection of food pipe and stomach) cancers are known to be aggressive with a 5 year survival of only 22% despite current treatment. Worldwide, there are estimated 951,600 newly diagnosed cases of gastric cancer accounting for an estimated 723,100 deaths per year. This is a phase 3 randomised, double-blind, placebo-controlled clinical trial testing whether pembrolizumab (MK-3745) improves survival in patients with stomach cancer more than placebo when added to standard of care (surgery and chemotherapy).
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) or PDL2 on its surface. When this tumour protein interacts with a receptor (programmed cell death 1, PD-1) on the surface of immune cells, it prevents immune-mediated tumour cell destruction. Pembrolizumab (MK-3475) is a highly selective monoclonal antibody designed to directly block PD-1/PDL1 or PD-1/PDL2 interaction. This allows the immune system to increase the immune attack on cancers. Pembrolizumab is currently licenced in Europe for the treatment of melanoma, lung cancer and lymphoma, with trials underway for several other cancers.
Approximately 800 male and female adults will be enrolled. Participants will be screened and randomised in a 1:1 ratio into either a treatment + pembrolizumab arm or a treatment + placebo arm. Participants will receive chemotherapy (cisplatin and a fluoropyrimidine) with pembrolizumab/placebo for 3 x 3-week cycles, followed by surgery (if tests show the cancer is removable), and then an additional 3 cycles of chemotherapy and 14 cycles of pembrolizumab/placebo. Participants will be followed for event-free survival and overall survival.The study is funded by Merck Sharp & Dohme Limited and will take place at 5 study centres in the UK.
REC name
London - Central Research Ethics Committee
REC reference
17/LO/1590
Date of REC Opinion
20 Oct 2017
REC opinion
Further Information Favourable Opinion