The CEDAR trial has now received OCTRU Green Light approval to commence recruitment, with the Churchill Hospital, Oxford, planning to be the first site to be activated in early July 2019.
CEDAR is a phase 1 trial investigating the safety, tolerability and biological effects of intravenous enadenotucirev, a novel oncolytic virus, in combination with standard of care chemoradiotherapy.
Up to 30 Patients with locally advanced rectal cancer will be recruited from 4 sites across the UK and will be allocated to one of 6 different dosing schedules, consisting of 2 different doses of the virus given over 3 different frequencies. A time to event continual reassessment method, alongside input from the TMG, will be used to decide the dosing schedule that is assigned to each patient. The primary objective of the trial is to determine the optimal dosing schedule that can be administered with chemoradiotherapy.
CEDAR is sponsored by the University of Oxford, funded by CRUK and PsiOxus Therapeutics, and managed by the Oncology Clinical Trials Office (OCTO). Statistical support is provided by the Centre for Statistics in Medicine (CSM). The Chief Investigator is Professor Maria Hawkins.