A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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)
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Recurrent Glioblastoma
Age (in years)
18+
Phase
Phase 3
Participants needed
529
Est. Completion Date
Apr 8, 2024
Treatment type
Interventional
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT02017717
Study number
CA209143
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