The IPI-GLIO trial has opened to recruitment.
This is an unblinded, open labelled stratified randomised Phase II multicentre clinical trial of ipilimumab with temozolomide vs. temozolomide alone after surgery and chemoradiotherapy in patients with recently diagnosed glioblastoma.
Patients with newly diagnosed de-novo glioblastoma following surgery and radical radiotherapy with concomitant temozolomide will be recruited from 7 sites in the UK, and randomly allocated to receive either ipilimumab and temozolomide or temozolomide alone. The first recruiting site to open is Mount Vernon Cancer Centre in Northwood.
IPI-GLIO is sponsored by the University of Oxford and managed by the Oncology Clinical Trials Office (OCTO). The trial is funded by Bristol-Myers Squibb and The National Brain Appeal. Statistical support is provided by the Centre for Statistics in Medicine (CSM). The Chief Investigator is Dr Paul Mulholland.