Description:
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.
Title
- Brief Title: 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)
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
CA209-548
- SECONDARY ID:
2015-004722-34
- NCT ID:
NCT02667587
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | Opdivo, Nivo, N, BMS-936558 | Nivolumab + Temozolomide + Radiotherapy |
Temozolomide | Temodar, TMZ, Temodal, Temcad | Nivolumab + Temozolomide + Radiotherapy |
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Nivolumab + Temozolomide + Radiotherapy | Experimental | 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 | |
Nivolumab placebo + Temozolomide + Radiotherapy | Placebo Comparator | 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 | |
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-free survival (PFS), Blinded Independent Central Review (BICR) assessed |
Time Frame: | Approximately 35 months after first patient randomized |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall Survival (OS) |
Time Frame: | up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Progression free survival (PFS), investigator assessed |
Time Frame: | Approximately 35 months after first patient randomized |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
September 11, 2020