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)

  • Interventional
  • Not Recruiting
  • NCT02667587
Eligibility Details Visit Clinicaltrials.gov

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

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT02667587

IRB#IRB16-0260

Lead SponsorBristol-Myers Squibb

Lead PhysicianSteven Chmura

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting