CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
avelumabbiological
Likely dose
Avelumab 10 mg/kg intravenouslyAI-extracted
Key inclusion· 7
  • Newly diagnosed supratentorial glioblastoma with tissue diagnosis from resection or biopsy, including prior low-grade astrocytoma upgraded to GBM
  • Age 18 years or older
  • Karnofsky performance score 70 or higher
  • Completed standard chemoradiation (60 Gy in 30 fractions with concurrent temozolomide 75 mg/m² daily) within the last 21 days
Key exclusion· 10
  • Leptomeningeal disease
  • Prior treatment with bevacizumab or any checkpoint immune blockade therapies
  • Radiotherapy completed more than 3 weeks prior to baseline
  • Prior organ transplantation including allogeneic stem cell transplantation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03047473
NCT03047473Phase 2Completed

Avelumab in Patients With Newly Diagnosed Glioblastoma Multiforme

Clinique Neuro-Outaouais·interventional·Posted Feb 9, 2017·Updated May 25, 2025

In Brief

A Phase 2 clinical trial evaluating avelumab for Glioblastoma Multiforme of Brain. Completed, enrolled 38 participants across 1 site.

Detailed Summary

This is a safety and tolerability study looking at the addition of avelumab, an immune checkpoint inhibitor, to standard therapy of temozolomide and radiotherapy in patients with newly diagnosed glioblastoma multiforme. All patients will be receiving active therapy. Patients will begin the avelumab within 3 weeks of finishing their radiotherapy. Avelumab will be given at a dose of 10mg/kg IV every 2 weeks concomitantly with the monthly temozolomide. Avelumab will be continued for a total of 52 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 9, 2017
Enrollment StartMay 19, 2017
Primary CompletionAug 9, 2021
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 9.4 years ago

Interventions

avelumabbiological

add on of avelumab 10mg/kg IV to standard therapy