NCT04984733

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: University of Southampton · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Adenocarcinoma - GEJ
• Cancer of Esophagus

Interventions

Type	Name	Description
DRUG	Temozolomide	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.
DRUG	Temozolomide 50mg/m2/day	Metronomic TMZ 50mg/m2/day orally until progression then nivolumab 240mg IV until progression
DRUG	Temozolomide 3 month	Metronomic TMZ 50mg/m2/day orally for 3 months, then nivolumab 240mg IV and TMZ until progression.
DRUG	Temozolomide 24month	Metronomic TMZ 50mg/m2/day orally for 3 months, then nivolumab 240mg IV and TMZ until a maximum of 24 months

Timeline

• Start date: 2021-09-28
• Primary completion: 2024-07-01
• Completion: 2026-07-01
• First posted: 2021-07-30
• Last updated: 2023-11-29

Locations

1 site across 1 country: United Kingdom