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.
Active, not recruiting
Phase 3
| Drug | Synonyms | Arms |
|---|---|---|
| Nivolumab | Nivolumab + Radiotherapy Arm | |
| Temozolomide | Temozolomide + Radiotherapy Arm |
| 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 |
|
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 |
| Measure: | Overall Survival (OS) |
| Time Frame: | up to 3 years |
| Safety Issue: | |
| Description: | OS is defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date. |
| Measure: | Progression Free Survival (PFS) |
| Time Frame: | up to 3 years |
| Safety Issue: | |
| Description: | PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Participants who did not have disease progression or who did not die will be censored at the date of last tumor assessment. Participants who did not have any on study tumor assessment and did not have tumor progression or die will be censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. Participants who had surgical resection post start of study treatment will be censored at the last tumor assessment date prior to initiation of surgical resection. PFS was determined by investigator reported response based on RANO criteria |
| Measure: | OS at 24 Months |
| Time Frame: | at 24 Months |
| Safety Issue: | |
| Description: | The OS rate at 24 months of nivolumab + RT and RT + TMZ was estimated as Kaplan-Meier probability of survival at 24 months. |
| Measure: | OS in Tumor Mutational Burden (TMB) High Population |
| Time Frame: | up to 3 years |
| Safety Issue: | |
| Description: | OS is defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date. |
| Measure: | PFS in Tumor Mutational Burden (TMB) High Population |
| Time Frame: | up to 3 years |
| Safety Issue: | |
| Description: | PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Participants who did not have disease progression or who did not die will be censored at the date of last tumor assessment. Participants who did not have any on study tumor assessment and did not have tumor progression or die will be censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. Participants who had surgical resection post start of study treatment will be censored at the last tumor assessment date prior to initiation of surgical resection. PFS was determined by investigator reported response based on RANO criteria |
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
February 3, 2021
