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

Status: Recruiting
Phase: Phase 2
Diagnosis: Brain/Neuro Cancer: Recurrent Glioblastoma
NCT ID: NCT02017717 (View complete trial on
DFCI Protocol ID: 13-630


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.


Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
David Reardon, MD, Dana Farber Cancer Institute

Site-responsible Investigators:
Jorg Dietrich, M.D., Massachusetts General Hospital
Eric Wong, MD, Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute: Lisa Doherty,
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit Inclusion Criteria: - Subjects 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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