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)

• Status: Active, not recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Ono Pharmaceutical Co. Ltd
• Treatments: Antibodies, Monoclonal; Dacarbazine; Nivolumab; Temozolomide

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Males and Females, age ≥ 18 years old

• Newly diagnosed brain cancer or tumor called glioblastoma or GBM

• Karnofsky performance status of ≥ 70 (able to take care of self)

• Substantial recovery from surgery resection

• Tumor test result shows MGMT methylated or indeterminate tumor subtype

Exclusion Criteria:

• Biopsy-only of GBM with less than 20% of tumor removed

• Prior treatment for GBM (other than surgical resection)

• Any known tumor outside of the brain

• Recurrent or secondary GBM

• Active known or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply