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OncoMatch/Clinical Trials/NCT04659811

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

Is NCT04659811 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pembrolizumab for grade i meningioma, adult.

Phase 2RecruitingNancy Ann Oberheim Bush, MDNCT04659811Data as of May 2026

Treatment: PembrolizumabThis 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.

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Extracted eligibility criteria

Disease stage

Grade: iiiii (who)

Prior therapy

Must have received: radiation therapy

Patients must have had one prior course of radiation therapy

Cannot have received: anti-PD-1 therapy (pembrolizumab)

Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent

Cannot have received: anti-PD-L1 therapy

Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent

Cannot have received: anti-PD-L2 therapy

Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent

Cannot have received: checkpoint inhibitor

agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137)

Lab requirements

Blood counts

ANC >= 1500/uL; Platelets >= 100000/uL; Hemoglobin >= 9.0 g/dL or >= 5.6 mmol/L (without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks)

Kidney function

Creatinine <= 1.5 x ULN OR measured or calculated creatinine clearance >= 30 mL/min for participant with creatinine levels > 1.5 x institutional ULN

Liver function

Total bilirubin <= 1.5 x ULN OR direct bilirubin <= ULN for participants with total bilirubin levels > 1.5 x ULN; AST and ALT <= 2.5 x ULN

ANC >= 1500/uL; Platelets >= 100000/uL; Hemoglobin >= 9.0 g/dL or >= 5.6 mmol/L (within 28 days prior to enrollment); Creatinine <= 1.5 x ULN OR measured or calculated creatinine clearance >= 30 mL/min; Total bilirubin <= 1.5 x ULN OR direct bilirubin <= ULN; AST and ALT <= 2.5 x ULN

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of California, San Francisco · San Francisco, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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