Pembrolizumab for High-Grade Meningioma

Recruiting in Palo Alto (17 mi)

+1 other location

Priscilla Brastianos | Breast Cancer ...

Overseen ByPriscilla K. Brastianos

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?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

Eligibility Criteria

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.

Inclusion Criteria

My meningioma has grown after I completed radiation therapy.

I can do most of my daily activities without help.

My meningioma has come back or spread beyond its original location.

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

My cancer has grown by 25% or more in less than 2 years.

I have a Grade II or III meningioma with measurable disease after surgery.

My meningioma has come back or spread beyond its original location.

My meningioma has spread beyond the brain.

My MRI shows a tumor in my brain that's at least 10mm big after surgery.

I am 18 years old or older.

Exclusion Criteria

I have a lesion in my brainstem.

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

I have been diagnosed with an immunodeficiency.

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

I have an active tuberculosis infection.

I do not have any unmanaged ongoing illnesses.

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

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

I am currently being treated for an infection.

I have been diagnosed with HIV.

I have an active Hepatitis B or C infection.

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

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

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

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: PembrolizumabExperimental Treatment1 Intervention

* Pembrolizumab will be administered every 3 weeks * Pembrolizumab will be administered through IV infusion

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: