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

Completed · Phase 3

Conditions studied: Brain Cancer

In brief

The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.

Key facts

Study ID

NCT02617589

Run by

Bristol-Myers Squibb

People needed

560

Starts

2016-03-01

Expected to finish

2022-03-04

Last updated by the study team

2023-03-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0083 — Phoenix, Arizona, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Local Institution - 0019 — Los Angeles, California, United States
• Sutter Institute For Medical Research — Sacramento, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• The Regents of the University of California, San Francisco — San Francisco, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• University Of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Emory University - Winship Cancer Institute — Atlanta, Georgia, United States
• The University Of Chicago — Chicago, Illinois, United States
• University Of Kansas Medical Center — Westwood, Kansas, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Johns Hopkins University School Of Medicine — Baltimore, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Local Institution - 0006 — Detroit, Michigan, United States
• Washington University School OF Medicine-Siteman Cancer Center — St Louis, Missouri, United States
• JFK Medical Center — Edison, New Jersey, United States
• Local Institution - 0064 — Hackensack, New Jersey, United States
• Columbia University Medical Center (Cumc) — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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