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)

• Status: Active, not recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

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.

• 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 BMS 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

• Tumor test result shows MGMT unmethylated type

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

Exclusion Criteria:

• 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

• Biopsy with less than 20% of tumor removed