49
Participants
Start Date
March 1, 2018
Primary Completion Date
September 12, 2022
Study Completion Date
October 27, 2023
Temozolomide
concomitant and 5-day adjuvant temozolomide
conformal brain radiation therapy
standard radiation therapy for newly diagnosed glioblastoma
Nivolumab
nivolumab 240 mg IV every 2 weeks for the first 28-day cycle, then option to modify to 480 mg IV every 4 weeks
Ipilimumab
ipilimumab 1 mg/kg IV every 6 weeks (or every 8 weeks when nivolumab is administered every 4 weeks) for a maximum of 4 doses
Bevacizumab
bevacizumab 5 mg/kg IV every 2 weeks (up to 10 mg/kg at treating physician's discretion)
5-day Temozolomide
150 mg/m\^2 oral, once daily on Days 1-5 of each 28-day cycle (stepwise titration every cycle up to 200 mg/m\^2 permitted)
5-day Temozolomide
100 mg/m\^2 oral, once daily on Days 2-6 of each 6 week course (stepwise titration every cycle up to 200 mg/m\^2 permitted)
Lomustine
100 mg/m\^2 oral, on Day 1 of each 6 week course
Nivolumab monotherapy
nivolumab 300 mg IV every 2 weeks for the first 28-day cycle, then option to modify to 480 mg IV every 4 weeks
Saint John's Cancer Institute, Santa Monica
Saint John's Cancer Institute
OTHER