Active — Not RecruitingPhase 2

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

United States35 participantsStarted 2021-03-25

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must have histologically confirmed World Health Organization (WHO) grade II or III meningioma that is progressive or with one or more recurrences following surgical resection and radiotherapy * Patients must be eligible/appropriate for treatment with radiation therapy, specifically, if radiation is given in a single session, the target volume cannot exceed 8 ccs or if given in five (consecutive business days) sessions, the target volume cannot exceed 20 ccs * Prior therapy: * There is no limit on the number of prior surgeries or systemically administered therapeutic agents * An interval of \>= 28 days and full recovery (no ongoing safety issues) from surgical resection * An interval of \> 7 days from stereotactic biopsy * For prior systemic agents, 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 * For prior radiotherapy, there are no exclusions on number of courses or prior type of radiotherapy. All modalities including prior fractionated external beam photon/proton radiotherapy, stereotactic radiosurgery, and/or or brachytherapy are permissible with a required interval of 6 months from last prior radiotherapy treatment, unless radiation given outside of the planned field, then within 2 weeks from prior radiotherapy treatment. Patients must have had one prior course of radiation therapy * Participants must have reco…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Up to 12 months

Trial details

NCT IDNCT04659811

SponsorNancy Ann Oberheim Bush, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-31

View on ClinicalTrials.gov More Grade I Meningioma, Adult trials