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

Completed · Phase 3

Conditions studied: Recurrent Glioblastoma

In brief

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.

Key facts

Study ID

NCT02017717

Run by

Bristol-Myers Squibb

People needed

529

Starts

2014-02-07

Expected to finish

2024-06-21

Last updated by the study team

2025-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States
• Local Institution - 0055 — Los Angeles, California, United States
• Local Institution - 0009 — Los Angeles, California, United States
• UCLA Neuro-Oncology Program — Los Angeles, California, United States
• Local Institution - 0014 — San Francisco, California, United States
• The Regents of the University of California, San Francisco — San Francisco, California, United States
• Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Local Institution - 0021 — Aurora, Colorado, United States
• Local Institution - 0001 — New Haven, Connecticut, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Local Institution - 0002 — Atlanta, Georgia, United States
• Winship Cancer Institute — Atlanta, Georgia, United States
• Johns Hopkins University School Of Medicine — Baltimore, Maryland, United States
• Local Institution - 0008 — Baltimore, Maryland, United States
• Beth Israel Deaconess Med Ctr — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Local Institution - 0006 — Boston, Massachusetts, United States
• Local Institution - 0043 — Boston, Massachusetts, United States
• Local Institution - 0056 — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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