NRG BN007

Official Title

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

Study Purpose

To compare the usual radiation therapy and usual chemotherapy, temozolomide, to using the usual radiation therapy plus the immune therapy drugs ipilimumab and nivolumab.

Diagnosis

Eligibility

Central Pathology Review for confirmation of (GBM) and of unmethylated MGMT promotor.

No known IDH mutation.

Contrast-enhanced brain MRI within 72 hours after surgery required.

No prior treatment for GBM

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

There are two study groups. Once the results of the tissue come in and the results conclude patient has glioblastoma and the unmethylated MGMT biomarker, the patient will be placed in one of the groups.

• Group 1: The usual treatment of radiation and temozolomide for 6 weeks, followed by temozolomide alone for up to 12 months

• Group 2: The usual radiation for 6 weeks plus the experimental study drug ipilimumab for up to 4 months and the experimental study drug nivolumab for as long as the patient seems to benefit from it.