Anaplastic Meningioma Clinical Trial
Official title:
A Phase II, Open-label, Single Arm Trial of Pembrolizumab for Refractory Atypical and Anaplastic Meningioma
A Phase II, Open-label, Single Arm Trial of Pembrolizumab for Refractory Atypical and Anaplastic Meningioma
This is a multicenter, prospective, single arm, open label, interventional study. The goal of
this study, is to evaluate feasibility and efficacy of pembrolizumab for the treatment of
recurrent or progressive meningioma (WHO grades II-III) or hemangiopericytoma (HPC). All
patients will receive IV pembrolizumab, at a dose of 200mg, every 3 weeks. Patients will be
treated until disease progression or intolerable toxicity. Treatment can be stopped after one
year of treatment in case of stable disease or completer response, with re-initiation of
treatment upon progression. Expression of PD1 and PD-L1 will be tested, on tumor cells, using
IHC staining on biopsy material obtained from previous surgeries.
All patients will have a baseline neurologic and clinical exam, MRI scan, a brain dedicated
CT-PET scan, a baseline cognitive exam and QOL assessment with a dedicated questionnaire.
Patients will have a clinical and neurological exam every treatment cycle. MRI scan will be
repeated after 2 months from the beginning of the trial drug administration and then every
2-3 months. There are no designated and specific criteria for response assessment in the
treatment of meningioma. Therefore, response evaluation will be made using the RECIST 1.1
criteria, as used for solid tumors. The trial will allow the continuation of pembrolizumab in
case of stable or improved clinical response, when pseudo-progression is suspected in the
MRI. In addition, response assessment will also be made according to the RANO criteria, as
used for high grade glioma. This will be compared to the RECIST evaluation, but will not be
used for treatment decision making.
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