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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

Must not have

Participants with brainstem lesions

Participants who have had chemotherapy, targeted small molecule therapy or study therapy within 14 days of protocol treatment, or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 35 months

Awards & highlights

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.

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.

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've been on a stable dose of dexamethasone (2mg or less) for the last week.

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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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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a lesion in my brainstem.

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I haven't had cancer treatment or recovered from its side effects in the last 2 weeks.

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I have been diagnosed with an immunodeficiency.

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I need to take more than 2mg/day of dexamethasone before starting therapy.

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I have an active tuberculosis infection.

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I do not have any unmanaged ongoing illnesses.

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I have an autoimmune disease treated with medication in the last 2 years.

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I have a history of lung inflammation not caused by an infection.

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I am currently being treated for an infection.

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I have been diagnosed with HIV.

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I have an active Hepatitis B or C infection.

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I have not received a live vaccine in the last 30 days.

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I have another cancer that is getting worse or needs treatment.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 35 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival at 6 Months (PFS6)

Secondary study objectives

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

Diarrhea

Anemia

Shortness of Breath

Abdominal pain

Kidney Injury and/or Infection

Pneumonia

Weight Loss

Dyspnea

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Atrial fibrillation with rapid ventricular response

Pleural effusion

colitis

Thrombocytopenia

Respiratory failure

Skin rash

100%

80%

60%

40%

20%

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

0 / 24Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,950 Previous Clinical Trials

5,174,957 Total Patients Enrolled

1 Trials studying Meningioma

37 Patients Enrolled for Meningioma

Massachusetts General HospitalLead Sponsor

2,993 Previous Clinical Trials

13,230,695 Total Patients Enrolled

5 Trials studying Meningioma

184 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

~3 spots leftby Sep 2025

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