Avelumab in Patients With Newly Diagnosed Glioblastoma Multiforme (SEJ)
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|ClinicalTrials.gov Identifier: NCT03047473|
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : February 6, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme of Brain||Biological: avelumab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||single center, add on, open label, single dose, single arm|
|Masking:||None (Open Label)|
|Official Title:||Avelumab in Patients With Newly Diagnosed Glioblastoma Multiforme|
|Actual Study Start Date :||March 10, 2017|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||March 2020|
Experimental: Newly diagnosed GBM
single arm, open label Addition of Avelumab to standard treatment
add on of avelumab 10mg/kg IV to standard therapy
- Safety and tolerability according to emergent adverse event leading to avelumab interruption or termination [ Time Frame: over the course of the 52 weeks stsudy ]
Safety and tolerability based on avelumab related adverse events leading to permanent or transient discontinuation of avelumab Treatment related adverse events of special interest will include those of autoimmune origin (irAE).
The adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0
- iRANO criteria [ Time Frame: over the course of the 52 weeks study ]Radiological tumor response will be graded according to the Immunotherapy Response Assessment for Neuro-Oncology (iRANO) criteria by a single study radiologist based on the gadolinium enhanced brain MRI performed at the study center at baseline and at the final visit (week 52) or within 2 weeks of the end of avelumab treatment visit and evaluations of locally obtained MRI's Clinical tumor response as per the iRANO criteria will be evaluated by the principal investigator based on the protocol specified neurological exams The OS and PFS will be stratified according to MGMT status, baseline age (>50yrs), baseline Karnofsky performance score (score of 100), whether the patient had a radical tumor resection vs biopsy and according to histopathological diagnosis of primary versus secondary GBM
- potential biomarkers of response [ Time Frame: over the course of the 52 weeks study ]
The correlation between OS and PFS and the prevalence of PD-L1 expression on tumor cells and microglia/macrophages within the tumor, the histological immunoscore.
The correlation between OS and PFS in relation the baseline corticosteroid dose, the average daily corticosteroid dose over the whole study duration, inability because of temozolomide related tolerability issues to complete the 6 month temozolomide cycles, the change from baseline to end of study neurocognitive function as measured by the evoked potential P300 and the incidence and severity of irAE's.
The change between baseline biomarker results and those obtained from biomarkers in tissue samples from patients with second surgical resection ie treatment failures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047473
|Contact: Francois Jacques, MDfirstname.lastname@example.org|
|Contact: Victorine Sikati Foko||819-777-2500 ext email@example.com|
|Gatineau, Quebec, Canada, J8Y 1W2|
|Contact: Victorine Sikati-Foko, RN Msc 819-777-2500 ext 3 firstname.lastname@example.org|
|Principal Investigator:||François Jacques, MD||Clinique Neuro-Outaouais|