At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 10 enrolled
Drug / intervention
Nivolumab +2 moredrug
Likely dose
Nivolumab 3 mg/kgfrom 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 Phase II, Open-label, Single Arm Trial of Nivolumab, Ipilimumab, and Short-course Radiotherapy in Adults With Newly Diagnosed, MGMT Unmethylated Glioblastoma
In Brief
A Phase 2 clinical trial evaluating Nivolumab, Ipilimumab, and 1 other intervention for MGMT-unmethylated Glioblastoma (GBM) and GBM. Completed, enrolled 10 participants across 1 site.
Detailed Summary
This is a single arm, open-label, phase II trial of nivolumab, ipilimumab and short-course radiation therapy in adult patients with newly diagnosed, MGMT unmethylated GBM with the primary objective of determining the overall survival at 1 year.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMGMT-unmethylated Glioblastoma (GBM), GBM
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 2017
Enrollment StartFeb 2018
Primary CompletionMay 2021
Study CompletionMar 2022
TodayJul 2026
First PostedDec 11, 2017
Enrollment StartFeb 7, 2018
Primary CompletionMay 20, 2021
Study CompletionMar 17, 2022
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 8.6 years ago
Interventions
Nivolumabdrug
study treatment on Day 1 with one dose of nivolumab 3 mg/kg
Ipilimumabdrug
study treatment on Day 1 with one dose of ipilimumab 1mg/kg
Radiation Therapy (RT)radiation
total dose of 30 Gy, given in 5 consecutive fractions of 6 Gy each fraction.