Phase 3
N=560
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)
Brain Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02617589 ↗Enrolled (actual)
560
Serious AEs
62.7%
Results posted
Feb 2021
Primary outcome: Primary: Overall Survival (OS) — 13.40; 14.88 Months — p=0.0037
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nivolumab (Drug); Temozolomide (Drug); Radiotherapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
13.40; 14.88 | 0.0037 sig |
| SECONDARY Kaplan-Meier Plot of Progression Free Survival |
6.01; 6.21 | — |
| SECONDARY Overall Survival Rate at 24 Months |
10.6; 21.2 | — |
| SECONDARY Overall Survival in Tumor Mutational Burden (TMB) High Population |
— | — |
| SECONDARY Progression Free Survival in Tumor Mutational Burden (TMB) High Population |
— | — |
Summary
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.
Eligibility Criteria
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
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02617589). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.