A Randomized Phase II/III Open-Label Study of Ipilimumab and Nivolumab Versus Temozolomide In Patients With Newly Diagnosed MGMT (Tumor O-6-Methylguanine DNA Methyltransferase) Unmethylated Glioblastoma
Principal Investigator
Andrew Lassman, MD
Status
Closed to Accrual
Date Opened To Accrual
August 06 2020
Date Closed to Accrual
March 29 2023
Disease Site
Brain [BN]
Malignant Glioma
Phase
II/III
Developmental Therapeutics
No
Primary Objective
Phase II : To determine if adding ipilimumab and nivolumab to radiotherapy significantly prolongs progression-free survival (PFS) versus adding temozolomide to radiotherapy in patients with newly diagnosed glioblastoma (GBM) without MGMT promoter methylation
Phase III : To determine if adding ipilimumab and nivolumab to radiotherapy significantly prolongs overall survival (OS) versus adding temozolomide to radiotherapy in patients with newly diagnosed GBM without MGMT promoter methylation
Patient Population
Histopathologically proven diagnosis of glioblastoma (orgliosarcoma as a subtype of glioblastoma) confirmed by central pathology review. MGMT promoter without methylation confirmed by central pathology review. IDH mutation testing by at least one method must be performed as part of standard of care and no mutation must be found.
Target Accrual
485
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.