Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer).
Basic Trial Information
Trial Description
Summary
The main purpose of this study is to compare how long patients with glioblastoma (GBM, a
malignant brain cancer) live after receiving temozolomide plus radiation therapy compared
with patients receiving nivolumab in addition to temozolomide plus radiation therapy.
Eligibility Criteria
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)
Full recovery from surgical resection
Tumor test result shows MGMT methylated, partially 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
Trial Contact Information
Trial Lead Organizations / Sponsors / Collaborators
Bristol-Myers Squibb
- Ono Pharmaceutical Company Limited
Trial Sites
U.S.A.
Ohio
Cleveland
Case Comprehensive Cancer Center
Manmeet Singh Ahluwalia
Principal Investigator
Principal Investigator
Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.
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