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BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

Trial ID CA209-548  |   NCT02667587

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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Sorry, this study is no longer accepting new participants, but is still ongoing.
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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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 Eligibility Criteria

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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Nivolumab + Temozolomide + Radiotherapy

ASSIGNED INTERVENTION
  • Drug: Nivolumab, Temozolomide
  • Radiation: Radiotherapy

Study Arms

Placebo Comparator: Nivolumab placebo + Temozolomide + Radiotherapy

ASSIGNED INTERVENTION
  • Drug: Temozolomide
  • Other: Nivolumab Placebo
  • Radiation: Radiotherapy

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Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com