NCT02667587

An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)

A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 716 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy.

Conditions

• Brain Neoplasms

Interventions

Type	Name	Description
DRUG	Nivolumab
DRUG	Temozolomide
RADIATION	Radiotherapy
OTHER	Nivolumab Placebo

Timeline

• Start date: 2016-05-09
• Primary completion: 2020-12-22
• Completion: 2024-04-09
• First posted: 2016-01-29
• Last updated: 2025-06-18
• Results posted: 2022-02-03

Locations

123 sites across 19 countries: United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Israel, Italy, Japan, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study