Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04659811 · ClinicalTrials.gov registry record · Phase 2
Stereotactic Radiosurgery and Immunotherapy (Pembrolizumab) for the Treatment of Recurrent Meningioma
A Phase 2 study of Recurrent Meningioma and Grade I Meningioma, Adult, sponsored by Nancy Ann Oberheim Bush, MD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT04659811: Recruiting Phase 2 study of Recurrent Meningioma and Grade I Meningioma, Adult, sponsored by Nancy Ann Oberheim Bush, MD.
NCT04659811 is a Phase 2 study of Recurrent Meningioma and Grade I Meningioma, Adult that is actively recruiting participants, run by Nancy Ann Oberheim Bush, MD. The registered enrollment target is 37 participants, below the 47-participant average among 6 other Recurrent Meningioma trials with a reported enrollment target (21% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04659811, a Phase 2 study of Recurrent Meningioma and Grade I Meningioma, Adult, is actively recruiting participants, sponsored by Nancy Ann Oberheim Bush, MD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Percentage of patients who are progression-free at the landmark of 12 months from start of treatment based on the target lesion(s) that are receiving radiation treatment will be reported. Tumor progression will be assessed using Immunotherapy Radiologic Assessment in Neuro-oncology Criteria (iRANO) and defined as \> 25% increase in sum of the products of perpendicular diameters of enhancing lesions (over baseline if no decrease) on stable or increasing doses of corticosteroids and/or a significa
Conditions Studied
Interventions
- DRUG Pembrolizumab
- PROCEDURE Stereotactic Radiosurgery
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2021-03-25 |
| Est. Completion | 2030-04-30 |
| Phase | Phase 2 |
What NCT04659811 shows while recruiting
NCT04659811 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 47-participant average among 6 other Recurrent Meningioma trials with a reported enrollment target (21% lower).
The record links to 4 conditions, with Recurrent Meningioma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04659811 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04659811 about?
NCT04659811 is a clinical study titled "Stereotactic Radiosurgery and Immunotherapy (Pembrolizumab) for the Treatment of Recurrent Meningioma". 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...
What is the current status of trial NCT04659811?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2021-03-25. Estimated completion is 2030-04-30.
What conditions does trial NCT04659811 study?
This clinical trial studies the following conditions: Recurrent Meningioma, Grade I Meningioma, Adult, Grade II Meningioma, Adult, Grade III Meningioma, Adult.
What interventions are being tested in trial NCT04659811?
The interventions under investigation include: Pembrolizumab (DRUG), Stereotactic Radiosurgery (PROCEDURE).
Who is sponsoring clinical trial NCT04659811?
This trial is sponsored by Nancy Ann Oberheim Bush, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04659811 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Meningioma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy
RECRUITING · Phase 2
-
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas
RECRUITING · Phase 2
-
Optune Delivered Electric Field Therapy and Bevacizumab in Treating Patients With Recurrent or Progressive Grade 2 or 3 Meningioma
RECRUITING · Phase 2
-
Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma
RECRUITING · NA
-
RYZ101 for the Treatment of Progressive or Recurrent Intracranial Meningioma
RECRUITING · Phase 1
-
Nivolumab and Multi-fraction Stereotactic Radiosurgery With or Without Ipilimumab in Treating Patients With Recurrent Grade II-III Meningioma
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02800486 · 37 participants · Phase 2
Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA
- NCT03173937 · 37 participants · Phase 1
Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome
- NCT03295227 · 37 participants · Phase 1
Pembrolizumab in Treating Participants With Unresectable Thymoma or Thymic Cancer
- NCT03401047 · 37 participants · Early Phase 1
Study to Assess Potential Impairments in Estradiol Augmentation of Gonadotropin Secretion in Polycystic Ovary Syndrome
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI