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Temozolomide + Nivolumab in MGMT Methylated Oesophagogastric Cancer

NCT04984733 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-05-18

No results posted yet for this study

Summary

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

Conditions

  • Adenocarcinoma - GEJ
  • Cancer of Esophagus

Interventions

DRUG

Temozolomide 24month

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

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

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.

Sponsors & Collaborators

Principal Investigators

  • Elizabeth Smyth · Cambridge University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-28
Primary Completion
2024-10-23
Completion
2024-10-23

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04984733 on ClinicalTrials.gov