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Clinical Trial VICCNEU1404


A Randomized Phase 3 Open Label Study of Nivolumab versus Bevacizumab and a Safety Study of Nivolumab or Nivolumab in Combination with Ipilimumab in Adult Subjects with Recurrent Glioblastoma (GBM)

Principal Investigator(s)

Stephen Clark


  • Protocol No. VICCNEU1404
  • Open Date: 07/30/2014
  • Staging: Phase III
  • Age Group: Adults
  • Scope: National
  • Objective: Cohort 1 (Safety Lead-in): To evaluate the safety of nivolumab and nivolumab in combination with ipilimumab Cohort 2: To compare the overall survival (OS) of nivolumab versus bevacizumab, and of nivolumab in combination with ipilimumab versus bevacizumab.
  • Disease Sites: Neuro-Oncology
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Avastin; Bevacizumab; Ipilimumab; Nivolumab (BMS-936558)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02017717
  • Secondary Protocol No: CA209143


Patients are being asked to take part in this research study because they have recurrent glioblastoma (GBM). The study is divided into two cohorts (groups). The purpose of Cohort 1 is to test the safety and tolerability of an investigational drug called nivolumab (also known as BMS-936558), either alone or in combination with a drug called ipilimumab (also known as Yervoy) in patients diagnosed with glioblastoma (a type of brain tumor). Both nivolumab and ipilimumab are antibodies (a type of human protein) that are being tested to see if it will allow the body-s immune system to work against tumor cells. The purpose of Cohort 2, is to test the effectiveness (how well the drug works), safety, and tolerability of nivolumab and of nivolumab in combination with ipilimumab will be compared with bevacizumab (Avastin). Bevacizumab is an anti-angiogenic (tumor starving/anti-cancer) therapy. Bevacizumab blocks a protein called vascular endothelial growth factor (VEGF). Blocking VEGF may prevent the growth of new blood vessels that feed tumors.


Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No


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)
• Any recurrence of GBM (Cohorts 1, 1b and 2 only)
• First diagnosis of GBM with resectable disease (Cohorts 1c and 1d only)
• Untreated unmethylated MGMT GBM (Cohort 1d only)
• Karnofsky performance status (PS) ≥ 70
Exclusion Criteria:
• More than 1 recurrence of GBM (Cohorts 1, 1b and 2 only)
• First 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 VEGF or anti-angiogenic treatment (Cohort 2 only)