Patients with Glioblastoma Multiforme (GBM) despite standard therapy have a dismal prognosis and thus represent a significant unmet medical need. GBM has well documented systemic and local immunosuppressive mechanisms to escape immune surveillance and grow. GBM tumor cells as well as the microglia within it have a high incidence of PD-L1 surface expression which makes it more susceptible to anti-PD-L1 antagonism and ADCC through avelumab therapy. Combination of avelumab with other anticancer therapies have been shown safe and perhaps synergistic. A clinical trial looking at adding avelumab to standard therapy in patients with GBM is therefore indicated.
This is a single center, phase 2, open label, open-ended add-on, single dose study of 52 weeks duration in patients receiving standard therapy for newly diagnosed GBM. In total 30 patients who meet the entry criteria will be entered into the study within 3 weeks of finishing their last day of combined radiotherapy/temozolomide. Avelumab will be initiated concurrently with the initiation of the first 5 day, monthly cycle of temozolomide and continued for a total of 52 weeks. The study will consist of 3 different phases: Combination Phase a Monotherapy Phase and an Extended Safety Follow-up Phase.
Clinical trial identification
Legal entity responsible for the study
Study is funded by an unrestricted grant from Merck Serono.
All authors have declared no conflicts of interest.