Clinique Neuro-Outaouais

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 Objectives and Endpoints:
Objective:
The primary objective of the study is to evaluate the feasibility and test-retest reliability of MEP's and (SSEP's) in a multicenter clinical trial in healthy subjects and subjects with MS.
Endpoints:
The primary reliability endpoint will be the intraclass correlation coefficient (ICC) of the following evoked potential parameters

Study Design:
Phase 4, pilot, single center, observational study. MEP's will be obtained twice, two weeks apart at baseline and every 6 months for 36 months (total of 14 sessions of MEP's)
MEP's will include:
Onset latencies and CMCT to bilateral abductor pollicis brevis and tibialis anterior muscles
MEP amplitudes and the ratio of the central to peripherally obtained motor amplitudes (MEP-M ratio) to bilateral abductor pollicis brevis and tibialis anterior muscles Clinical measures (EDSS, MEP's, T25FWT, 6MWT, 9HPT) will be obtained at baseline and every 6 months for 36 months.
Study location: Single center in Canada
Study Objectives:
Primary: To evaluate the reliability of MEP's in Alemtuzumab treated MS patients over a 36 month period.
Secondary: To determine the degree of correlation between MEP's and presently used clinical measures of efficacy (EDSS, 6MWT, T25FWT, 9HPT) and to determine if MEP's can predict who will require a third cycle of Alemtuzumab.