ELEVATE
Research type
Research Study
Full title
ELEVATE: Temozolomide + nivolumab in MGMT deficient oesophagogastric cancer
IRAS ID
282284
Contact name
Elizabeth Smyth
Contact email
Sponsor organisation
University of Southampton
Eudract number
2020-004771-41
ISRCTN Number
ISRCTN11398887
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Surgery is the only curative option for patients with oesophagogastric adenocarcinoma, but despite the use of multimodality therapy which combines it with chemo and/or radiotherapy, more than 50% of patients will relapse and die. Many of the UK patients present with advanced disease which is already inoperable or metastatic at diagnosis. For these patients, standard care chemotherapy only offers them survival of less than a year. Nivolumab (a checkpoint blockade inhibitor) has been found to work in some advanced cancers. It is proposed for those where it hasn't worked - that these immunologically evasive tumours need to be sensitized to immunotherapy drugs to allow them to act. In this trial we will aim to sensitize the tumour with temozolomide (TMZ) to increase its sensitivity to nivolumab. Patients will be treated for up to 3 months with TMZ prior to commencing nivolumab either in conjuction with TMZ or alone.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
21/EE/0017
Date of REC Opinion
15 Mar 2021
REC opinion
Further Information Favourable Opinion