At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 716 enrolled
Drug / intervention
Nivolumab +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma
In Brief
A Phase 3 clinical trial evaluating Nivolumab, Temozolomide, and 2 other interventions for Brain Neoplasms. Completed, enrolled 716 participants across 123 sites in 19 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Neoplasms
CountriesAustralia, Austria, Belgium, Canada, Denmark, France, Germany, Israel, Italy, Japan, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland, United Kingdom, United States
CollaboratorsOno Pharmaceutical Co., Ltd.
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartMay 2016
Primary CompletionDec 2020
Study CompletionApr 2024
TodayJul 2026
First PostedJan 29, 2016
Enrollment StartMay 9, 2016
Primary CompletionDec 22, 2020
Study CompletionApr 9, 2024
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 10.4 years ago
Interventions
Nivolumabdrug
Temozolomidedrug
Radiotherapyradiation
Nivolumab Placeboother