Phase I Study of Ipilimumab, Nivolumab, and the Combination in Patients With Newly Diagnosed Glioblastoma
Principal Investigator
Mark Gilbert, MD
Status
Terminated
Date Opened To Accrual
April 16 2015
Date Closed to Accrual
August 16 2017
Date of Study Termination
December 22 2022
Disease Site
Brain [BN]
Malignant Glioma
Phase
I
Developmental Therapeutics
Yes
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.
Patient Population
Histopathologically proven diagnosis of glioblastoma or gliosarcoma prior to registration by pathology report. The tumor must be unifocal, confined to the supratentorial compartment and have undergone a gross total or near gross total resection.
Please note
This is a limited-institution study with pre-selected sites.
Target Accrual
42