NCT02017717

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 529 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	specified dose on specified days
BIOLOGICAL	Bevacizumab	specified dose on specified days
BIOLOGICAL	Ipilimumab	specified dose on specified days

Timeline

• Start date: 2014-02-07
• Primary completion: 2019-06-17
• Completion: 2024-06-21
• First posted: 2013-12-23
• Last updated: 2025-04-04
• Results posted: 2022-06-29

Locations

112 sites across 12 countries: United States, Australia, Belgium, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study