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Clinical Trial Summary

An open label single arm phase II trial in patients with advanced unresectable previously treated oesophagogastric adenocarcinoma which is MGMT deficient.


Clinical Trial Description

The aim of the ELEVATE trial is to determine the activity and safety of maintenance TMZ dosing followed by nivolumab treatment to evaluate the potential for a future randomised trial against a standard of care control arm. The rationale to continue TMZ for 3 months or until PD is to evaluate the emergence of mismatch repair deficiency both with and without radiological PD, as clinically relevant MMRd may emerge before radiological progression. This will also reduce the number of patients who drop out due to symptomatic progressive disease. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04984733
Study type Interventional
Source University of Southampton
Contact Elizabeth Smyth
Phone 023 81205773
Email elizabeth.smyth2@nhs.net
Status Recruiting
Phase Phase 2
Start date September 28, 2021
Completion date July 2026

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