Study flow chart.
SOC = standard of care; TMZ = temozolomide
Treatment scheme is the same for all patients throughout the course of the study, regardles of treatment group (ICT-107 or Control)
*Chemoradiation for 6 weeks: induction TMZ (75 mg/m2/day for 42 days) and focal radiotherapy (60 Gy in 30 fractions, 5 days/week for 6 weeks)
§ Administered 5 days per week for 12 months. Cycle 1: 150 mg/m2/day × 5. Cycles 2 −12: 200 mg/m2/day × 5
β Maintenance administration on day 21 of cycles 1, 3, 6, 10, coupled with maintenance TMZ. if TMZ is delayed, these vaccinations will also be delayed to ensure TMZ and vaccination cycles remain synchronized. Extended maintenance administration at cycles 16, 22 and continuing every 6 months until depletion or confirmation of PD