Study of Nivolumab versus Temozolomide, given with radiation therapy, for newly-diagnosed patients with glioblastoma (GBM, a malignant brain cancer)
Phase 1
- Conditions
- nmethylated MGMT (tumor O-6-methylguanine DNA methyltransferase) GlioblastomaMedDRA version: 20.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-003739-37-BE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1200
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)
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 960
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method