Temozolomide + Nivolumab in MGMT Methylated Oesophagogastric Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

September 28, 2021

Primary Completion Date

July 31, 2024

Study Completion Date

July 31, 2026

Conditions
Adenocarcinoma - GEJCancer of Esophagus
Interventions
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

Trial Locations (1)

CB2 0QQ

RECRUITING

Cambridge University Hospitals NHS Foundation Trust, Cambridge

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

University of Southampton

OTHER