NCT04659811

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

Active, enrolled Phase 2 Last updated 15 April 2026

What this trial tests

Phase 2 trial testing Pembrolizumab in Grade I Meningioma, Adult in 35 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

25 March 2021

Primary endpoint
31 March 2027

31 March 2031

Quick facts

Lead sponsor	Nancy Ann Oberheim Bush, MD
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	25 March 2021
Primary completion	31 March 2027
Estimated completion	31 March 2031
Sites	1 location across United States

Drugs / interventions tested

• Pembrolizumab (pembrolizumab) — full drug profile →
• Stereotactic Radiosurgery

Conditions studied

• Grade I Meningioma, Adult — all drugs for Grade I Meningioma, Adult →
• Grade II Meningioma, Adult — all drugs for Grade II Meningioma, Adult →
• Grade III Meningioma, Adult — all drugs for Grade III Meningioma, Adult →
• Recurrent Meningioma — all drugs for Recurrent Meningioma →

Sponsor

Nancy Ann Oberheim Bush, MD

Who can join

18 and older, any sex, with Grade I Meningioma, Adult or Grade II Meningioma, Adult. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Meningioma: A Review of Epidemiology, Pathology, Diagnosis, Treatment, and Future Directions.
   Ogasawara C, Philbrick BD, Adamson DC. · · 2021 · cited 183× · PMID 33801089 · DOI 10.3390/biomedicines9030319
2. Meningioma: International Consortium on Meningiomas consensus review on scientific advances and treatment paradigms for clinicians, researchers, and patients.
   Wang JZ, Landry AP, Raleigh DR, Sahm F, et al · · 2024 · cited 100× · PMID 38695575 · DOI 10.1093/neuonc/noae082
3. Activity of PD-1 blockade with nivolumab among patients with recurrent atypical/anaplastic meningioma: phase II trial results.
   Bi WL, Nayak L, Meredith DM, Driver J, et al · · 2022 · cited 65× · PMID 34015129 · DOI 10.1093/neuonc/noab118
4. Emerging systemic treatment options in meningioma.
   Mair MJ, Berghoff AS, Brastianos PK, Preusser M. · · 2023 · cited 47× · PMID 36181606 · DOI 10.1007/s11060-022-04148-8
5. Intracranial meningiomas: an update of the 2021 World Health Organization classifications and review of management with a focus on radiation therapy.
   Yarabarla V, Mylarapu A, Han TJ, McGovern SL, et al · · 2023 · cited 31× · PMID 37675219 · DOI 10.3389/fonc.2023.1137849
6. The integrated multiomic diagnosis of sporadic meningiomas: a review of its clinical implications.
   Robert SM, Vetsa S, Nadar A, Vasandani S, et al · · 2022 · cited 21× · PMID 34846640 · DOI 10.1007/s11060-021-03874-9
7. Benchmarking the efficacy of salvage systemic therapies for recurrent meningioma: A RANO group systematic review and meta-analysis to guide clinical trial design.
   Kotecha R, Akdemir EY, Kutuk T, Ilgın C, et al · · 2025 · cited 12× · PMID 39807850 · DOI 10.1093/neuonc/noaf009
8. Clinical Significance of Molecular Alterations and Systemic Therapy for Meningiomas: Where Do We Stand?
   Pellerino A, Bruno F, Palmiero R, Pronello E, et al · · 2022 · cited 11× · PMID 35565385 · DOI 10.3390/cancers14092256