OncoMatch/Clinical Trials/NCT04984733
Temozolomide + Nivolumab in MGMT Methylated Oesophagogastric Cancer
Is NCT04984733 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Temozolomide and Temozolomide 50mg/m2/day for adenocarcinoma - gej.
Treatment: Temozolomide · Temozolomide 50mg/m2/day · Temozolomide 3 month · Temozolomide 24month — An open label single arm phase II trial in patients with advanced unresectable previously treated oesophagogastric adenocarcinoma which is MGMT deficient.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Biomarker criteria
Required: MGMT methylation
MGMT methylation on archival tissue
Required: MMR proficient
Mismatch repair proficient (MSI-normal or MMR intact)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — advanced disease
Previously treated with at least 3 months of platinum and fluoropyrimidine based chemotherapy for advanced disease and without evidence of disease progression.
Must have received: fluoropyrimidine — advanced disease
Previously treated with at least 3 months of platinum and fluoropyrimidine based chemotherapy for advanced disease and without evidence of disease progression.
Cannot have received: alkylating agent (temozolomide)
Previous treatment with TMZ
Cannot have received: anti-PD-1 therapy
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
Lab requirements
Blood counts
WBC > 1.5 x 10^9/L; ANC > 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Haemoglobin ≥ 90 g/L
Kidney function
Measured/calculated creatinine clearance ≥ 60 mL/min (Cockroft-Gault formula)
Liver function
Total bilirubin within normal limits (if the patient has documented Gilbert's disease ≤ 1.5 x ULN or direct bilirubin ≤ 1.5 x ULN); AST and/or ALT ≤ 1.5 x ULN
Cardiac function
Clinically significant abnormal 12-lead ECG or, if indicated, abnormal echocardiography or MUGA scan; serious cardiac illness or medical condition in past 6 months (CHF, high-risk arrhythmias, angina requiring medication, significant valvular disease, transmural infarction, poorly controlled hypertension)
Adequate organ function assessed within 7 days before randomization: WBC > 1.5 x 10^9/L, ANC > 1.5 x 10^9/L, Platelets ≥ 100 x 10^9/L, Haemoglobin ≥ 90 g/L, creatinine clearance ≥ 60 mL/min, bilirubin within normal limits, AST/ALT ≤ 1.5 x ULN; cardiac: abnormal ECG, echocardiography or MUGA scan, or serious cardiac illness in past 6 months
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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