The trial ‘ReACT Study’ will run in parallel with Celldex’s Phase 3 trial (ACT IV) evaluating rindopepimut in patients with newly diagnosed EGFRvIII-expressing glioblastoma (GB).
Rindopepimut is an investigational immunotherapeutic vaccine that targets the tumor-specific molecule epidermal growth factor receptor variant III (EGFRvIII).
The study will enroll approximately 95 patients in the first or second relapse of glioblastoma following receipt of standard therapy.
Around 70 Avastin (bevacizumab) naive patients will be randomized to receive either rindopepimut or a control injection of KLH)in a blinded fashion.
In addition, 25 patients refractory to Avastin, having received Avastin in either the frontline or recurrent setting with subsequent progression, will receive rindopepimut plus Avastin in a single treatment arm.