VESTIGE (EORTC 1707-GITCG)
Research type
Research Study
Full title
Adjuvant immunotherapy in patients with resected gastric cancer following preoperative chemotherapy with high risk for recurrence (N+ and/or R1): an open label randomized controlled phase-2-study (VESTIGE)
IRAS ID
254503
Contact name
Ian Chau
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer (EORTC)
Eudract number
2018-000406-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 4 months, 28 days
Research summary
This study is for adults who have a type of stomach cancer called gastric cancer (GC) or oesophagogastric junction adenocarcinoma (EGJ), and have who have received surgery and pre-operative chemotherapy.
The purpose of the study is to find out whether the combination of immune therapy (nivolumab and ipilimumab) is better at preventing the recurrence of GC and EGJ than standard chemotherapy. This is measured by the length of time until the disease worsens (disease free survival).Oesophagogastric cancer is one of the most common cancers globally and a major health problem in Europe. Considering the known toxicities of traditional chemotherapy, and the presence of chemoresistance, a switch to a different treatment is attractive for high risk postoperative patients. The use of immunotherapy including nivolumab and ipilimumab and a combination of the two, has been investigated as potentially beneficial in clinical trials in other cancer types. This study builds on the encouraging observations seen.
This study will take place in NHS sites in the UK as part of a wider international study. The study is sponsored and coordinated by the EORTC (European Organisation for Research and Treatment of Cancer), a non-profit organisation based in Brussels.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
19/LO/0518
Date of REC Opinion
6 Jun 2019
REC opinion
Further Information Favourable Opinion