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Active, Not Recruiting

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) - CA209-548

Updated: 26 February, 2024   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Nivolumab + Temozolomide + Radiotherapy
Radiation: Radiotherapy Drug: Temozolomide, Nivolumab
Placebo Comparator: Nivolumab placebo + Temozolomide + Radiotherapy
Other: Nivolumab Placebo Radiation: Radiotherapy Drug: Temozolomide

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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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