NRG-BN007

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 B. Lassman

Status

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 (or
gliosarcoma 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