Description:
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.
Title
- Brief Title: 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)
- Official Title: 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)
Clinical Trial IDs
- ORG STUDY ID:
CA209-498
- SECONDARY ID:
2015-003739-37
- NCT ID:
NCT02617589
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | | Nivolumab + Radiotherapy Arm |
Temozolomide | | Temozolomide + Radiotherapy Arm |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Nivolumab + Radiotherapy Arm | Experimental | Nivolumab IV infusion + Radiotherapy dose as specified | |
Temozolomide + Radiotherapy Arm | Active Comparator | Temozolomide + Radiotherapy dose as specified | |
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall survival (OS) |
Time Frame: | Approximately 3 years |
Safety Issue: | |
Description: | Overall survival: Defined as the time between the date of randomization and the date of death due to any cause |
Secondary Outcome Measures
Measure: | Progression free survival (PFS) |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | Progression free survival: Defined as the time from randomization to the date of the first documented tumor progression or death due to any cause |
Measure: | Overall survival |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
February 5, 2018