Characteristics of the Patients
glioblastoma, rigors
GLIOBLASTOMA, DISEASE, TUMOR RECURRENCE, SIDE EFFECT
From June 2018 to November 2019, we enrolled 12 patients with isocitrate dehydrogenase–wildtype glioblastoma in the study; 5 were analyzed in part A and 7 in part B. The first patient in part A withdrew from the intervention of receiving avelumab after experiencing rigors during the first infusion, a known side effect of the drug that was easily controlled with supportive measures. He was replaced by another patient. He continued treatment with nivolumab at his request, another drug that blocks the PD-1-PD-L1 pathway. After enrolling the third patient, 2 other patients that were eligible for the trial returned to the clinic simultaneously to sign consent to participate in part A of the study. It was felt that denying participation to one of them would be unethical. Part B followed part A. As 1 of 3 experimented a DLT, 3 other patients were enrolled. As only 1 of 6 experienced a DLT in part B, we initiated the expansion cohort and treated the first patient. Unfortunately, with the COVID-19 pandemic, elective surgical procedures were halted in 2020 in New York City. Therefore, we were unable to continue patient accrual, and we were forced to close the study remaining open for follow-up of the enrolled patients and completing the correlative studies. In total, there were 7 men (58%) and 5 women (42%), with a median age of 64 years (range, 37–73 years; Patient demographics and baseline characteristicsAll patients were previously treated with standard radiotherapy and concurrent temozolomide, followed by adjuvant temozolomide prior to the first tumor recurrence. Patients in part A completed a median of four cycles of avelumab (range, 1–16) compared with a median of eight cycles (range, 3–58) in part B. Two patients in part A received neoadjuvant ICI (Disease course, response to treatment, and outcomes. Six patients received bevacizumab in addition to avelumab (