RecruitingPhase 2NCT04984733

Temozolomide + Nivolumab in MGMT Methylated Oesophagogastric Cancer

An Open Label Single Arm Phase II Trial in Patients With Advanced Unresectable Previously Treated Oesophagogastric Adenocarcinoma Which is MGMT Deficient


Sponsor

University of Southampton

Enrollment

18 participants

Start Date

Sep 28, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of temozolomide (an oral chemotherapy) and nivolumab (an immunotherapy) in people with advanced stomach or esophageal cancer whose tumors have a specific genetic feature called MGMT methylation, which may make them more sensitive to temozolomide. **You may be eligible if...** - You are 18 or older - You have confirmed advanced esophageal, stomach, or gastroesophageal junction cancer that cannot be surgically removed - Your tumor has MGMT methylation (a specific epigenetic marker) - Your tumor's DNA repair is normal (not MSI-high) - You have already received at least 3 months of standard platinum and fluoropyrimidine chemotherapy without getting worse - You are in good health (ECOG 0–1) and can swallow capsules **You may NOT be eligible if...** - Your tumor has high microsatellite instability (MSI-H) - Your blood counts or organ function do not meet required levels - You have active autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTemozolomide

Metronomic TMZ 50mg/m2/day orally for 3 months then nivolumab 240mg IV +/- TMZ until progression. Patients who don't progress on TMZ will commence with combination treatment; TMZ + Nivolumab at 3 mths. Patients who progress on TMZ will start monotherapy with nivolumab. Patients will remain on monotherapy with nivolumab or combination therapy until progression or up to a maximum of 24mths.

DRUGTemozolomide 50mg/m2/day

Metronomic TMZ 50mg/m2/day orally until progression then nivolumab 240mg IV until progression

DRUGTemozolomide 3 month

Metronomic TMZ 50mg/m2/day orally for 3 months, then nivolumab 240mg IV and TMZ until progression.

DRUGTemozolomide 24month

Metronomic TMZ 50mg/m2/day orally for 3 months, then nivolumab 240mg IV and TMZ until a maximum of 24 months


Locations(1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04984733


Related Trials