NCT02617589

An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)

A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT (Tumor O-6-methylguanine DNA Methyltransferase) Glioblastoma (CheckMate 498: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 498)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 560 (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-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.

Conditions

• Brain Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab
DRUG	Temozolomide
RADIATION	Radiotherapy

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-01-17
• Completion: 2022-03-04
• First posted: 2015-12-01
• Last updated: 2023-03-28
• Results posted: 2021-02-03

Locations

125 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