At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 560 enrolled
Drug / intervention
Nivolumab +2 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 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT (Tumor O-6-methylguanine DNA Methyltransferase) Glioblastoma (CheckMate 498: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 498)
In Brief
A Phase 3 clinical trial evaluating Nivolumab, Temozolomide, and 1 other intervention for Brain Cancer. Completed, enrolled 560 participants across 125 sites in 19 countries.
Detailed Summary
The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Cancer
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 PostedDec 2015
Enrollment StartMar 2016
Primary CompletionJan 2019
Study CompletionMar 2022
TodayJul 2026
First PostedDec 1, 2015
Enrollment StartMar 1, 2016
Primary CompletionJan 17, 2019
Study CompletionMar 4, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 10.6 years ago
Interventions
Nivolumabdrug
Temozolomidedrug
Radiotherapyradiation