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RECRUITING
NCT04659811
PHASE2

Stereotactic Radiosurgery and Immunotherapy (Pembrolizumab) for the Treatment of Recurrent Meningioma

Sponsor: Nancy Ann Oberheim Bush, MD

View on ClinicalTrials.gov

Summary

This phase II trial studies the effect of stereotactic radiosurgery and pembrolizumab in treating patients with meningioma that has come back (recurrent). Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. It is used to treat brain tumors and other brain disorders that cannot be treated by regular surgery. Pembrolizumab is a humanized monoclonal antibody. An antibody is a common type of protein made in the body in response to a foreign substance. Antibodies attack foreign substances and protect against infection. Antibodies can also be produced in the laboratory for use in treating patients; an antibody that is made in the lab is also known as a humanized monoclonal antibody. Pembrolizumab is a highly selective humanized monoclonal antibody that is designed to block the action of the receptor PD-1. It has been studied in lab experiments and in other types of cancer. The PD-1 receptor works to keep the immune system from noticing tumor cells. The addition of pembrolizumab to stereotactic radiosurgery may improve the progression free survival of patients with meningioma.

Official title: A Phase II Study of Stereotactic Radiosurgery in Conjunction With the PD-1 Inhibitor, Pembrolizumab for the Treatment of Recurrent Meningioma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

37

Start Date

2021-03-25

Completion Date

2030-04-30

Last Updated

2025-04-17

Healthy Volunteers

No

Interventions

DRUG

Pembrolizumab

200mg given intravenously (IV) on day 1 (to -1) of radiation and then every 3 weeks until progression or unacceptable toxicity

PROCEDURE

Stereotactic Radiosurgery

Given in (a) single session treatment with margin dose of 15-20 Gy to the target for a maximum target volume of 8 cc or (b) five consecutive business days treatment to total dose of 25-30 Gy to the target for a maximum target volume of 20 cc when the target volume exceeds 8 cc or the target is in proximity to critical structures

Locations (1)

University of California, San Francisco

San Francisco, California, United States