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Trial ID CA209-143  |   NCT02017717

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

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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 the study is to compare the efficacy and safety of nivolumab administered alone versus bevacizumab in patients diagnosed with recurrent glioblastoma (a type of brain cancer, also known as GBM), and to evaluate the safety and tolerability of nivolumab administered alone or in combination with ipilimumab in patients with different lines of GBM therapy.

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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)

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Active Comparator: Arm B: Bevacizumab

ASSIGNED INTERVENTION
  • Biological: Bevacizumab

Study Arms

Experimental: Arm N + I:Nivolumab + Ipilimumab

ASSIGNED INTERVENTION
  • Biological: Nivolumab, Ipilimumab

Study Arms

Experimental: Arm N:Nivolumab

ASSIGNED INTERVENTION
  • Biological: Nivolumab