For Healthcare Professionals

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)

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  • For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
  • Inclusion Criteria:


    1. Males and Females, age ≥ 18 years old
    2. Newly diagnosed brain cancer or tumor called glioblastoma or GBM
    3. Karnofsky performance status of ≥ 70 (able to take care of self)
    4. Substantial recovery from surgery resection
    5. Tumor test result shows MGMT methylated or indeterminate tumor subtype

    EXCLUSION CRITERIA

    Exclusion Criteria:


    1. Biopsy-only of GBM with less than 20% of tumor removed
    2. Prior treatment for GBM (other than surgical resection)
    3. Any known tumor outside of the brain
    4. Recurrent or secondary GBM
    5. Active known or suspected autoimmune disease

    Other protocol defined inclusion/exclusion criteria could apply


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    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply


    Contact the study center to learn if this study is a good match for you.

    Study’s details


    Contition

    Brain Neoplasms

    Age (in years)

    18+

    Phase

    Phase 3

    Participants needed

    716

    Est. Completion Date

    Feb 19, 2024

    Treatment type

    Interventional


    Sponsor

    Bristol-Myers Squibb

    ClinicalTrials.gov identifier

    NCT02667587

    Study number

    CA209548

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