This research study is studying a drug as a possible treatment for High Grade Meningioma. The drug involved in this study is an immunotherapy drug called pembrolizumab
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved pembrolizumab for this specific disease but it has been approved for other uses. In this research study, the investigators are studying pembrolizumab in participants with meningioma. Research studies have shown that meningioma tumor cells express a gene called PD-L1. The investigators will be looking to determine whether the study drug may may stop meningioma tumors from growing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Progression-free Survival at 6 Months (PFS6)
Progression-free survival at 6 months is defined as not having disease progression per RANO (response assessment in neuro-oncology) criteria or death from any cause within six months of the first day of treatment with pembrolizumab. Contrast-enhanced cranial magnetic resonance imaging (MRI) was performed every 6 weeks to assess patient response to treatment. Progressive disease is defined per RANO criteria as the appearance of a new lesion, an increase in the size of a patient's existing lesions, or clear clinical worsening (seizures, medication side effects, complications of therapy, cerebrovascular events, infection, etc.)
Time frame: up to 6 months
Overall Survival (OS)
OS is defined as the time from protocol registration until death due to any cause. The follow-up of patients who were alive at the time of analysis was censored at the date of last assessment of vital status. 90% confidence intervals for median OS were estimated using log(-log(survival)) methodology.
Time frame: Up to 35 months
Overall Survival (OS) at 3 Months
OS benchmarked at 3 months measures the percentage of participants who are still alive at 3 months, after study registration and receiving study therapy.
Time frame: 3 months
Overall Survival (OS) at 6 Months
OS benchmarked at 6 months measures the percentage of participants who are still alive at 6 months, after study registration and receiving study therapy.
Time frame: 6 months
Percentage of Participants With Treatment-related Adverse Events
All adverse events (AEs) recorded during the trial were summarized for all patients who received one or more doses of pembrolizumab. This outcome measure includes adverse events assessed as at least possibly related to study therapy and grade 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.
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Time frame: Up to 26 months
Number of Participants With Intracranial Response
Intracranial response is defined as complete response (CR), partial response (PR), or stable disease (SD) by RANO (response assessment for neuro-oncology) criteria. Intracranial response was assessed by contrast-enhanced cranial magnetic resonance imaging (MRI) every 6 weeks. CR: complete disappearance of all enhancing measurable and non-measurable disease sustained for 4+ weeks, no new lesions, stable/decreasing corticosteroids, and patient is stable and improved clinically. Participants with non-measurable disease cannot have a CR; the best possible response is SD. PR: greater than or equal to 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for 4+ weeks, no progression of non-measurable disease, no new lesions, stable/decreasing corticosteroids, and patient is stable or improved clinically. SD: does not qualify for CR, PR, or disease progression and patient is stable clinically.
Time frame: Up to 25 months