An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)

Completed · Phase 3 · Has a placebo group

Conditions studied: Brain Neoplasms

In brief

The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy.

Key facts

Study ID

NCT02667587

Run by

Bristol-Myers Squibb

People needed

716

Starts

2016-05-09

Expected to finish

2024-04-09

Last updated by the study team

2025-06-18

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
• Karnofsky performance status of ≥ 70 (able to take care of self)
• Substantial recovery from surgery resection
• Tumor test result shows MGMT methylated or indeterminate tumor subtype

You may not qualify if…

• Biopsy-only of GBM with less than 20% of tumor removed
• 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
• Other protocol defined inclusion/exclusion criteria could apply

Where it is running

• Local Institution - 0003 — Phoenix, Arizona, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Local Institution - 0010 — Los Angeles, California, United States
• Local Institution - 0128 — Sacramento, California, United States
• Local Institution - 0029 — San Diego, California, United States
• Local Institution - 0006 — San Francisco, California, United States
• Local Institution - 0004 — New Haven, Connecticut, United States
• Local Institution - 0031 — Washington D.C., District of Columbia, United States
• Local Institution - 0087 — Miami, Florida, United States
• Local Institution - 0030 — Tampa, Florida, United States
• Local Institution - 0022 — Chicago, Illinois, United States
• Local Institution - 0060 — Westwood, Kansas, United States
• Local Institution - 0018 — Louisville, Kentucky, United States
• Local Institution - 0020 — Baltimore, Maryland, United States
• Local Institution - 0011 — Boston, Massachusetts, United States
• Local Institution - 0028 — Boston, Massachusetts, United States
• Local Institution - 0035 — Detroit, Michigan, United States
• Local Institution - 0002 — St Louis, Missouri, United States
• Local Institution - 0017 — Edison, New Jersey, United States
• Local Institution - 0012 — Hackensack, New Jersey, United States
• Local Institution - 0015 — New York, New York, United States
• Local Institution - 0024 — New York, New York, United States
• Local Institution - 0032 — Charlotte, North Carolina, United States
• Preston Robert Tisch Brain Tumor Center at Duke University — Durham, North Carolina, United States
• Local Institution - 0023 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.