PHASE I STUDY OF IPILIMUMAB, NIVOLUMAB, AND THE COMBINATION IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA
Treatment Location: N/A
1. Primary Objective Determine the maximum safe dose of single-agent treatment with ipilimumab, nivolumab and the combination when given with temozolomide during maintenance treatment for newly diagnosed glioblastoma. 2. Secondary Objectives Collect and record the side effect profiles for single-agent treatment with ipilimumab, nivolumab, and the combination when given with temozolomide during the maintenance phase for newly diagnosed glioblastoma. Perform pilot studies of immune cells within tumor samples, (e.g. phenotyping tumor infiltrating lymphocytes (TILs) by interrogating tumor tissues from diagnostic tumor blocks. Report the number of patients alive at 1 and 2 years after the start of single-agent treatment with ipilimumab, nivolumab, and the combination when given with temozolomide during the maintenance phase for newly diagnosed glioblastoma.
IRB Review and Approval Date: 03/24/2016
Recruitment Status: Closed
Projected Accrual: N/A
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