Study of Temozolomide plus Radiation Therapy with Nivolumab or placebo, for newly diagnosed patients with glioblastoma (GBM, a malignant brain cancer).
- Conditions
- MGMT-Methylated (tumor O6-methylguanine DNA methyltransferase) GlioblastomaMedDRA version: 18.1Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-004722-34-ES
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 360
- 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)
- Full recovery from surgical resection
- Tumor test result shows MGMT methylated, partially methylated, or indeterminate tumor subtype
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 288
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 72
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main purpose of this study is to compare how long patients with glioblastoma (GBM, a malignant brain cancer) live<br>after receiving temozolomide plus radiation therapy compared with patients receiving nivolumab in addition to<br>temozolomide plus radiation therapy;Secondary Objective: Progression free survival, defined as the time from randomization to the date of the first documented tumor progression or death to any cause.;Primary end point(s): Overall survival defined as time from the date of randomization to the date of death.;Timepoint(s) of evaluation of this end point: Approximately 54 months after FPFV
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Progression free survival, defined as the time from randomization to the date of the first documented tumor progression or death to any cause.;Timepoint(s) of evaluation of this end point: Approximately 54 months after FPFV