A Trial of Pembrolizumab for Refractory Atypical and Anaplastic Meningioma
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|ClinicalTrials.gov Identifier: NCT03016091|
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atypical Meningioma Anaplastic Meningioma Hemangiopericytoma||Drug: Pembrolizumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-label, Single Arm Trial of Pembrolizumab for Refractory Atypical and Anaplastic Meningioma|
|Actual Study Start Date :||February 20, 2018|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2022|
Experimental: Arm 1
IV Pembrolizumab 200mg, given every 3 weeks until disease progression or intolerable toxicity
- progression free survival (PFS) [ Time Frame: 6 months ]To determine the 6 months progression free survival (PFS) rate for patients with recurrent or progressive meningioma on pembrolizumab therapy, using the RECIST 1.1 criteria.
- progression free survival (PFS) [ Time Frame: 12 months ]To determine the 12 months progression free survival (PFS) rate for patients with recurrent or progressive meningioma on pembrolizumab therapy, using the RECIST 1.1 criteria.
- Overall survival (OS) [ Time Frame: 4 years ]To determine OS of patients with recurrent or progressive meningioma treated with pembrolizumab.
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): NCT03016091
|Contact: Dror Limon, Drfirstname.lastname@example.org|
|Contact: Shlomit Yust-Katz, Dremail@example.com|
|Rabin Medical Center||Recruiting|
|Petach Tikva, Israel|
|Principal Investigator: Shlomit Yust-Katz, MD|
|Tel Aviv Medical Center||Not yet recruiting|
|Tel Aviv, Israel|
|Contact: Dror Limon, MD|
|Principal Investigator: Dror Limon, MD|