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Active, Not Recruiting

A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients - CA209-143

Updated: 2 June, 2022   |   ClinicalTrials.gov

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Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Active Comparator: Arm B: Bevacizumab
Biological: Bevacizumab
Experimental: Arm N + I:Nivolumab + Ipilimumab
Biological: Nivolumab Biological: Ipilimumab
Experimental: Arm N:Nivolumab
Biological: Nivolumab

Key Eligibility Criteria

Inclusion Criteria: - Participants with histologically confirmed Grade IV malignant glioma - Previous treatment with radiotherapy and temozolomide (Cohorts 1, 1b and 2 only) - First recurrence of GBM (Cohorts 1, 1b and 2 only) - First diagnosis of GBM with resectable disease (Cohorts 1c Part A only) - First diagnosis of unmethylated MGMT GBM (Cohort 1d and Cohort 1c Part B only) - Karnofsky performance score of 70 or higher Exclusion Criteria: - More than 1 recurrence of GBM (Cohorts 1, 1b and 2 only) - Any recurrence of GBM (Cohorts 1c and 1d only) - Presence of extracranial metastatic or leptomeningeal disease - Active, known or suspected autoimmune disease - Clinically significant cardiovascular disease - Prior bevacizumab or other Vascular Endothelial Growth Factor (VEGF) or anti-angiogenic treatment (Cohort 2 only)

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