Phase 3
N=716
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)
Brain Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT02667587 ↗Enrolled (actual)
716
Serious AEs
67.1%
Results posted
Feb 2022
Primary outcome: Primary: Progression-free Survival (PFS) Determined by BICR — 10.64; 10.32 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nivolumab (Drug); Temozolomide (Drug); Radiotherapy (Radiation); Nivolumab Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) Determined by BICR |
10.64; 10.32 | — |
| PRIMARY Overall Survival (OS) |
28.91; 32.07; 31.34; 32.99 | 0.3402 |
| SECONDARY Overall Survival (OS) Rates at 12 Months |
82.7; 87.7 | — |
| SECONDARY Overall Survival (OS) Rates at 24 Months |
55.9; 63.3 | — |
| SECONDARY Progression Free Survival (PFS) Based on Investigator Assessment |
14.09; 15.18 | — |
Summary
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.
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
Data sourced from ClinicalTrials.gov (NCT02667587). 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.