Temozolomide + Nivolumab in MGMT Methylated Oesophagogastric Cancer
Trial Parameters
Brief Summary
An open label single arm phase II trial in patients with advanced unresectable previously treated oesophagogastric adenocarcinoma which is MGMT deficient.
Eligibility Criteria
INCLUSION CRITERIA * Patients ≥ 18 years of age * Pathologically confirmed advanced unresectable or metastatic OGA * MGMT methylation on archival tissue * Mismatch repair proficient (MSI-normal or MMR intact) * Previously treated with at least 3 months of platinum and fluoropyrimidine based chemotherapy for advanced disease and without evidence of disease progression. * Measurable disease per RECIST 1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Can swallow TMZ capsules * Adequate organ function assessed within 7 days before randomization: * White blood cell count (WBC) \> 1.5 x 109/L * Absolute neutrophil count (ANC) \> 1.5 x 109/L * Platelets ≥ 100 x 109/L * Haemoglobin ≥ 90 g/L * Measured/calculated creatinine clearance ≥ 60 mL/min (according to Cockroft-Gault formula). * Total bilirubin within normal limits (if the patient has documented Gilbert's disease ≤ 1.5 x ULN or direct bilirubin ≤ 1.5 x ULN) * Aspartate transaminase (AST) and/or alanine tran