A randomized clinical trial for the treatment of glioblastoma multiforme with the individualized dendritic cell-based cancer immunotherapy AV0113.

2052 Background: We recruited 78 patients aged 18-70 years suffering from newly diagnosed glioblastoma multiforme (GBM) into a randomized clinical trial designed for demonstrating the efficacy of the individualized dendritic cell-based cancer immunotherapy concept AV0113 (GBM-Vax, EudraCT 2009-015979-27). DC are charged with autologous tumor antigens and contacted with lipopolysaccharide (LPS) in the presence of Interferon (IFN) -γ enabling IL-12 secretion for 1 day thus priming cytolytic anti-tumor immune responses. Exposure to LPS/IFN-γ is limited to 6 hours in order to permit DC/T-lymphocyte interaction in the presence of IL-12. Methods: Patients underwent first line GBM therapy (surgery, radiotherapy, chemotherapy) according to the standard of care; patients randomized into the treatment group received AV0113 as add-on therapy. Primary and secondary objectives were PFS and OS. After progression, patients were treated with Bevacizumab, which was not part of the protocol. The study still collects follow...