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Monoclonal Antibodies

Stereotactic Radiosurgery + Immunotherapy for Meningioma

Phase 2

Recruiting

Led By Nancy Oberheim Bush, MD, PhD

Research Sponsored by Nancy Ann Oberheim Bush, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be >= 18 years of age on day of signing informed consent

Participants must be at least 4 weeks (or 5 half-lives, whichever is shorter) from other prior cytotoxic chemotherapy (6 weeks from nitrosoureas) or biologic therapies

Must not have

History of (non-infectious) pneumonitis that required steroids or has current pneumonitis

Known history of human immunodeficiency virus (HIV) (testing not required)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a single dose of radiation therapy, given with the help of special equipment to target the tumor precisely, and a laboratory-made protein that blocks the PD-1 receptor, may improve progression-free survival for patients with meningioma that has come back.

Who is the study for?

Adults with recurrent grade II or III meningioma, previously treated with surgery and radiotherapy. Participants must be in good health otherwise, not pregnant or breastfeeding, willing to use contraception, and have no other active cancers or severe psychiatric issues. They should not have had recent immunosuppressive treatments or live vaccines.

What is being tested?

The trial is testing the combination of stereotactic radiosurgery (precise radiation therapy) and pembrolizumab (an immune system-boosting drug) to see if it can improve survival without cancer growth in patients with recurring brain tumors called meningiomas.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in various organs, infusion reactions, fatigue, skin rash, hormone gland problems like thyroid disorders, and could 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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I am 18 years old or older.

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I haven't had chemotherapy or biologic therapy for at least 4 weeks.

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I had an MRI within the last 28 days and have been on a low, stable dose of steroids.

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My meningioma is grade II or III, has grown or returned after surgery and radiation.

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I am eligible for radiation therapy with specific volume limits based on the number of sessions.

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My kidney function, measured by creatinine or GFR, is within the required range.

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I am able to care for myself but may not be able to do active work.

Exclusion Criteria

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

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I have had pneumonitis treated with steroids or currently have it.

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I have a known history of HIV.

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I have a history of hepatitis B or active hepatitis C.

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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

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

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I have been treated with specific immune therapy drugs before.

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I have an active TB infection.

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I am currently being treated for an infection.

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I haven't taken immunosuppressive drugs like methotrexate in the last 3 months.

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My cancer has spread outside the brain and spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of participants with Progression Free Survival at 12 months (PFS12)

Secondary study objectives

Median overall survival (OS)

Median progression free survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment for recurrent meningioma (pembrolizumab, stereotactic radiosurgery)Experimental Treatment2 Interventions

Participants with recurrent grade II or III meningioma will receive stereotactic radiosurgery. in conjunction with pembrolizumab 200mg IV infusion on day 1 (to -1) of radiation and then every 3 weeks. Participants may be eligible for up to 17 additional cycles of pembrolizumab depending on disease status after completion of first course.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Stereotactic Radiosurgery

2021

Completed Phase 2

~440