Phase II Trial of Pembrolizumab in Recurrent or Residual High Grade Meningioma
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|ClinicalTrials.gov Identifier: NCT03279692|
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : September 7, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|High Grade Meningioma||Drug: Pembrolizumab||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Pembrolizumab in Recurrent or Residual High Grade Meningioma|
|Actual Study Start Date :||November 7, 2017|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2025|
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
Other Name: Keytruda
- Progression Free Survival [ Time Frame: Every 6 weeks, up to 6 months ]Contrast-enhanced cranial MRI will be performed every 6 weeks. PFS6 is defined as not having progressive disease or death within six months of the first day of treatment. Contrast-enhanced cranial magnetic resonance imaging (MRI) will be performed every 6 weeks.
- Overall Survival [ Time Frame: 3 months and 6 months ]The distributions of overall survival will be summarized using the method of Kaplan-Meier. The follow-up of patients who are alive at the time of analysis will be censored at the date of last assessment of vital status. Median OS will be presented and accompanied by 90% confidence intervals estimated using log(-log(survival)) methodology. Survival point estimates at 3 and 6 months will also be presented with confidence intervals.
- Toxicity [ Time Frame: Baseline to 21 days ]All adverse events recorded during the trial will be summarized for all patients having received one or more doses of pembrolizumab. The proportions of patients with grade-3 or higher hematologic toxicities or grade-3 or higher neurologic toxicities will be presented with 90% exact binomial confidence intervals.
- Intracranial response [ Time Frame: 6 months ]The proportion of patients with intracranial response (CR, PR or SD by RANO) will be presented with a two-sided, 90% exact binomial confidence interval.
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): NCT03279692
|Contact: Nicola Gribbin||617-726-9579||NGRIBBIN@PARTNERS.ORG|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Eudocia Lee, MD 617-632-2166|
|Principal Investigator: Eudocia Lee, MD|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02214|
|Contact: Priscilla K Brastianos, MD 617-724-8770 firstname.lastname@example.org|
|Principal Investigator: Priscilla Brastianos, MD|
|Principal Investigator:||Priscilla Brastianos, MD||Massachusetts General Hospital|