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Monoclonal Antibodies

Pembrolizumab for High-Grade Meningioma

Phase 2
Waitlist Available
Led By Priscilla Brastianos, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with measurable and progressive meningioma who have received radiation and show evidence of progressive disease in the radiated field after completion of radiation
ECOG Performance Status < 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 35 months
Awards & highlights

Study Summary

This trial is studying pembrolizumab to see how well it works in treating patients with high grade meningioma.

Who is the study for?
This trial is for adults with recurrent or residual high-grade meningioma. Candidates can have had previous treatments but must show measurable disease progression post-radiation, if applicable. They should be in good physical condition (ECOG Performance Status < 2), not pregnant or nursing, and on a stable low dose of dexamethasone. People with brainstem lesions, active infections, certain psychiatric conditions, recent immunosuppressive treatments, known hypersensitivity to pembrolizumab or its components are excluded.Check my eligibility
What is being tested?
The study tests Pembrolizumab's effectiveness for treating high-grade meningioma that has recurred after treatment or remains after surgery. Participants will receive this immunotherapy drug to see how it affects their cancer compared to the standard care they would otherwise receive.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver problems, skin reactions, hormone gland issues (like thyroid dysfunction), and could potentially worsen pre-existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My meningioma has grown after I completed radiation therapy.
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I can do most of my daily activities without help.
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My meningioma has come back or spread beyond its original location.
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I have had multiple treatments for my condition.
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I've been on a stable dose of dexamethasone (2mg or less) for the last week.
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I have stable brain tumors for 6 months due to NF.
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My cancer has grown by 25% or more in less than 2 years.
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I have a Grade II or III meningioma with measurable disease after surgery.
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I may or may not have had previous medical treatments.
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I agree to use contraception during the study.
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My meningioma has come back or spread beyond its original location.
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My meningioma has spread beyond the brain.
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My recent tests show my organs and bone marrow are functioning well.
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My MRI shows a tumor in my brain that's at least 10mm big after surgery.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 35 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 35 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival at 6 Months (PFS6)
Secondary outcome measures
Number of Participants With Intracranial Response
Overall Survival (OS)
Overall Survival (OS) at 3 Months
+2 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: PembrolizumabExperimental Treatment1 Intervention
Pembrolizumab will be administered every 3 weeks Pembrolizumab will be administered through IV infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,918 Previous Clinical Trials
13,192,809 Total Patients Enrolled
5 Trials studying Meningioma
184 Patients Enrolled for Meningioma
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,674 Total Patients Enrolled
1 Trials studying Meningioma
37 Patients Enrolled for Meningioma
Priscilla Brastianos, MDPrincipal InvestigatorMassachusetts General Hospital
6 Previous Clinical Trials
479 Total Patients Enrolled
1 Trials studying Meningioma
124 Patients Enrolled for Meningioma

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03279692 — Phase 2
Meningioma Research Study Groups: Pembrolizumab
Meningioma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03279692 — Phase 2
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03279692 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been accepted into the experiment thus far?

"Unfortuantely, the aforementioned trial has closed its enrollment window; it was initially posted on November 7th 2017 and last updated July 29 2021. However, there are currently 46 medical studies recruiting patients with high grade meningioma and 961 trials for Pembrolizumab in progress."

Answered by AI

What risk factors should be taken into account when utilizing Pembrolizumab?

"Pembrolizumab's safety rating is 2, as it has been trialled in Phase 2 but efficacy data is still lacking."

Answered by AI

For what maladies can Pembrolizumab be prescribed?

"Pembrolizumab is regularly prescribed to those with malignant neoplasms, yet it can also assist patients dealing with advanced melanoma, microsatellite instability high tumours, and chemo-resistance."

Answered by AI

Are there any vacancies remaining for this investigation?

"Clinicaltrials.gov stipulates that this clinical trial is not enrolling any further patients at this time, which was last updated on July 29th 2021 and originally posted November 7th 2017. Nevertheless, there are over one thousand other medical trials currently in need of participants."

Answered by AI

Is there prior research on Pembrolizumab that can inform our current understanding?

"Currently, there are 961 active studies involving pembrolizumab; 122 of which have reached the third phase. Houston has several locations running this trial, but overall 35727 medical centres worldwide have started trials utilizing pembrolizumab."

Answered by AI

Who else is applying?

What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have had two surgeries and two courses of radiation for high grade meningioma with metastasis to spine.
PatientReceived 1 prior treatment
~4 spots leftby Mar 2025