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)
Purpose
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.
Condition
- Brain Neoplasms
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Nivolumab + Temozolomide + Radiotherapy |
Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks |
|
|
Placebo Comparator Nivolumab placebo + Temozolomide + Radiotherapy |
Nivolumab Placebo: specified dose on specified days; IV infusion Temozolomide: 75 mg/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units 5x/week x 6 weeks |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Bristol-Myers Squibb