A Trial of Pembrolizumab for Refractory Atypical and Anaplastic Meningioma (NCT03016091) | Clinical Trial Compass
TerminatedPhase 2
A Trial of Pembrolizumab for Refractory Atypical and Anaplastic Meningioma
Stopped: Slow accrural, dismal results
Israel18 participantsStarted 2018-01-01
Plain-language summary
A Phase II, Open-label, Single Arm Trial of Pembrolizumab for Refractory Atypical and Anaplastic Meningioma
Who can participate
Age range18 Years β 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
β. Be willing and able to provide written informed consent/assent for the trial.
β. Be 18 years of age on day of signing informed consent.
β. Have measurable disease based on RECIST 1.1.
β. Histologically, previously proven, grade II or III meningioma, HPC or classic radiographic features of a recurrent surgically inaccessible atypical or anaplastic meningioma.
β. All patients would have to have recurrence despite radiotherapy, unless radiotherapy is contraindicated.
β. No limit on the number of prior surgeries, radiation or radiosurgery treatments.
β. No limit on prior systemic therapies - chemotherapy or biological agents.
β. Patients who received stereotactic radiosurgery (SRS) are eligible without histologic documentation of recurrence if at least 6 months have passed from previous SRS treatment, and preferably, but not necessarily a 2-ο¬uoro-2-deoxy-D-glucose PET imaging demonstrated hypermetabolism.
Exclusion criteria
β. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
β. Has a diagnosis of immunodeficiency or is receiving other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
. Patients who are steroid dependent and cannot reduce the dexamethasone dose to a maximal dose of 2mg per day.
β. Has a known history of active TB (Bacillus Tuberculosis)
β. Hypersensitivity to pembrolizumab or any of its excipients.
β. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., β€ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
β. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., β€ Grade 1 or at baseline) from adverse events due to a previously administered agent.
β. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.