This study is in progress, not accepting new patients

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

a study on Astrocytoma Glioblastoma Glioma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study start
estimated completion
Principal Investigator
by Nicholas Butowski
Headshot of Nicholas Butowski
Nicholas Butowski

Description

Summary

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.

Official Title

A Randomized Phase 3 Open Label Study of Nivolumab Versus Bevacizumab and Multiple Phase 1 Safety Cohorts of Nivolumab or Nivolumab in Combination With Ipilimumab Across Different Lines of Glioblastoma

Details

Allocation: Randomized (Cohorts 1, 2 and Part B of 1c/1d), Non-Randomized (Cohorts 1b, and Part A of 1c/1d)

Keywords

Recurrent Glioblastoma, Glioblastoma, Bevacizumab, Nivolumab, Ipilimumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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)

Locations

  • Local Institution - 0014
    San Francisco California 94143-0372 United States
  • The Regents of the UCSF
    San Francisco California 94143-0372 United States

Lead Scientist at UCSF

  • Nicholas Butowski
    Dr. Nicholas Butowski is a neuro-oncologist who specializes in brain tumors, neuroimaging, cognitive and rehabilitative neurology, and complementary therapies for neurological disorders. He is director of clinical services in neuro-oncology and a researcher at the Brain Tumor Center.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting FDA Safety Alerts and Recalls
ID
NCT02017717
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 529 people participating
Last Updated