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)

  • Interventional
  • Not Recruiting
  • NCT02617589
Eligibility Details Visit Clinicaltrials.gov

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)

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT02617589

IRB#IRB16-0259

Lead SponsorBristol-Myers Squibb

Lead PhysicianSteven Chmura

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting