Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Study of Nivolumab Compared to Temozolomide, Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)

Protocol: OSU-15304

Full Title

A Randomized Phase III Open Label Study of Nivolumab vs Temozolomide Each in Combination with Radiation Therapy in Newly Diagnosed Adult Subjects with Unmethylated MGMT (tumor O-6-methylguanine DNA methyltransferase) Glioblastoma

Purpose

The main purpose of this study is to compare how long patients with glioblastoma (GBM, a

malignant brain cancer) live after receiving nivolumab every two weeks in addition to

radiation therapy (RT), and then every four weeks, compared with patients receiving standard

therapy with temozolomide in addition to RT.

Are you eligible?

Inclusion Criteria:

Males and Females, age ≥ 18 years old

Newly-diagnosed brain cancer or tumor called glioblastoma or GBM

Tumor test result shows MGMT unmethylated type

Karnofsky performance status of ≥ 70 (able to care for self)

Exclusion Criteria:

Prior treatment for GBM (other than surgical resection)

Any known tumor outside of the brain

Recurrent or secondary GBM

Active known or suspected autoimmune disease

Biopsy with less than 20% of tumor removed