Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Recurrence

Meningioma

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Multisession radiosurgery (hypofractionated radiotherapy) with Cyberknife

Radiosurgery

Renato Mantegazza, MD

Laura Fariselli, MD

Fractionated radiosurgery will be delivered to atypical meningioma lesions in salvage setting for patients who present post-surgical residual lesion or develop recurrence.

Meningioma is the most common intracranial tumor (1). World Health Organization (WHO) grade II (atypical) meningioma recurs more frequently than WHO grade I (benign) meningioma, and patients with subtotally resected atypical meningioma should be treated with adjuvant radiation therapy (2). However, many atypical meningiomas can be gross totally resected, and whether to administer radiation to this population remains unclear. Apart from extent of resection, clinical characteristics such as age and gender and tumor-related characteristics such as tumor size and location have poor predictive capacity to determine which lesions will recur.

The lack of professional consensus on the role of adjuvant radiation therapy (RT) derived from the heterogeneity and retrospective nature of the published data: standard fractionation fails to demonstrate a benefit in term of local control and survival.

Recent advances in radiotherapy technology (staged radiosurgery) give the possibility to reach high dose levels only in tumor volume and in the same time to save the surrounding healthy tissues.

The purpose of this study is to verify the related toxicity of a new radiotherapy protocol and as second end point to evaluate the efficacy on disease local control at 3 years.

Multisession Radiosurgery in Residual/Recurrent Grade II Meningiomas.

Hypofractionated Stereotactic Radiotherapy (Multisession Radiosurgery) in Residual/Recurrent Grade II Meningiomas: Feasibility Study.

Frequency of neurological side effects related to the radiosurgical treatment, evaluated according with CTCAE scale at every follow-up (4 months post-treatment, then every 6 months).

The rate of tumor response defined as follow on the basis of modification of MRI imaging evaluated also with advanced RM techniques:Partial response (PR) is defined as 20%, decrease in the volumetric size of the lesion on MRI; stable disease (SD) as no change in the size of the lesion; progressive disease (PD) increase in any volumetric size of the lesion, confirmed at least a the following two consecutive MR

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Glioblastoma

Glioma

Medulloblastoma

Pinealoma

Astrocytoma

Ependymoma

Oligodendroglioma

Rhabdoid Tumor

Gliosarcoma

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Choroid Plexus Neoplasms

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Brain Neoplasms

Brain Diseases

Central Nervous System Diseases

Cerebral Ventricle Neoplasms

Pineocytoma

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Neuroepithelioma

Diffuse Astrocytoma

Pilocytic Astrocytoma

Pleomorphic Xanthoastrocytoma

Gliomatosis Cerebri

Anaplastic Pleomorphic Xanthoastrocytoma

ONC206 is a member of the imipridone class of anti-cancer small molecules that share a unique tri-heterocyclic core chemical structure and target G protein-coupled receptors.

ONC206

Chris Tedesco

Marion Morrison, MD

Referrals

Kelly Mentges, RN

Mark Gilbert, MD

The primary objective of this Phase 1, open-label, dose-escalation, and exploratory study is to evaluate the safety and tolerability profile (establish the maximum-tolerated dose) and evaluate the occurrence of dose-limiting toxicities (DLTs) following single weekly or multiple-day weekly dose regimens of single-agent, oral ONC206 in patients with recurrent, primary central nervous system (CNS) neoplasms.

This is a Phase I, open-label, dose-escalation, and exploratory study of ONC206 in patients with recurrent, primary CNS neoplasms. All patients will be informed about the study and potential risks and required to provide written informed consent prior to undergoing study-related procedures.

There will be a total of 11 Dose Levels. Dose-escalation for Dose Levels 1 through 5 proceeded according to standard 3+3 design using a 28-day DLT window. The first cohort of 3 patients enrolled into the study received Dose Level 1 followed by increments as per the modified Fibonacci sequence. It is anticipated that approximately 46 patients will be enrolled in order to determine the MTD of ONC206.

For Dose Levels 1 through 5, a safety evaluation was conducted when 3 evaluable patients have completed 1 cycle (28 days) of therapy. After Protocol Amendment 6, all available PK data will also be considered for dose escalation decisions. Dose levels may be adjusted based on review of PK data but will not exceed maximum dose levels described in Table 6. Additionally, dose frequencies (e.g., once daily or 3 times daily) may be added and/or removed based on emerging PK data and concentration projections.

Prior to advancing/changing dose levels, a cohort summary must be completed and submitted to the sponsor Medical Monitor, for review and approval. Dose escalation for subsequent patients will proceed as follows:

* If no DLT is reported at a dose level, that dose level will be considered safe, and patient(s) will be enrolled at the next dose level. Toxicity information will continue to be evaluated from the time of the first protocol specific intervention, until 30 days from the last dose of study drug.
* If 1 patient in a cohort of 1 experiences a DLT, the dose level will be expanded to obtain an additional 2 evaluable patients.
* If 1 patient in a cohort at a dose level experiences a DLT, the dose level will be expanded to obtain an additional 3 evaluable patients.
* If 2 of 3 patients in a cohort at a dose level experience a DLT, that dose level will not be considered safe, no further dose escalation will take place, and the MTD will have been exceeded\*.
* If 1 patient experiences a DLT among the expanded cohort of evaluable patients, a cohort of 3 patients will be enrolled in the next higher dose level.
* If 2 or more patients experience a DLT among the expanded cohort of evaluable patients, that dose level will not be considered safe, no further dose escalation will take place, and the MTD will have been exceeded\*. The previous dose level at which ≤1 patients experienced a DLT will be declared the MTD.

  * When the MTD has been exceeded:

If less than 6 patients have been treated in the next lower dose level (the possible MTD level), additional patients will be entered into this dose level until there are 6 patients treated. If ≤1 of these 6 patients encountered DLT, then this dose level will be declared to be the MTD. If 2 or more of the 6 patients encounter DLT, then the MTD has been exceeded.

Given the experience with ONC201, it is possible a MTD may not be reached through the planned dose escalation cohorts. If the therapeutic target concentrations have been achieved in the dose escalation cohorts, and no DLT has been identified, then analysis of the safety and PK data will be evaluated by the Investigators and the Sponsor. Further dose levels may then be considered at higher intermittent dosing schedules and will be added by protocol amendment with review by the Institutional Review Board (IRB) before implementation.

Toxicities will be graded using the Common Terminology Criteria for Adverse Events Version 24.0 (CTCAE 24.0). If the CTCAE 24.0 does not apply to an adverse event, it will be graded as mild, moderate, or severe.

DLTs will be assessed during the first course of each cohort (28 days), and refers to a study drug related or possibly related event that meets 1 of the following criteria using the NCI CTCAE version 5.0:

* Grade 3 or higher non-hematologic toxicity.
* Grade 4 hematologic toxicity (ANC \<0.5 × 109/L and platelet count \<25 × 109/L). Lymphopenia is not considered a DLT. A confirmed DLT requires 2 consecutive measurements separated by 48 hours.
* Grade 3 neutropenia (ANC \<1.0 × 109/L) with elevated fever (\>101°F). A confirmed DLT requires 2 consecutive measurements.
* Grade 3 thrombocytopenia with clinically significant bleeding.
* Inability to receive the scheduled Cycle 2, Day 1 dose of study drug within 14 days due to study drug-related toxicity persisting from Cycle 1 or study drug-related toxicity newly encountered on Day 1 of Cycle 2.

Safety and tolerability will be monitored by assessing physical examinations including height (at Screening only) and weight, KPS, vital signs, ECG, laboratory assessments including hematology, chemistry, and coagulation, as well as collecting of the AEs at every visit.

Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms

A First-in-human Phase I Single-agent Dose-escalation, Food Effect and Dose Expansion Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms

MTD was determined by testing increasing doses up to 200 mg twice daily for 3 successive days a week.

MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in \>33% of participants. DLTs will be assessed in the first course of each cohort (28 days), and refer to a study drug-related or possibly related event that meets 1 of the following criteria defined in the subsequent Primary Outcome Measure using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE 5.0).

DLTs will be assessed in the first course of each cohort (28 days), and refer to a study drug-related or possibly related event that meets 1 of the following criteria using NCI CTCAE 5.0:

* Grade 3 or higher non-hematologic toxicity.
* Grade 4 hematologic toxicity (ANC \<0.5 × 109/L and platelet count \<25 × 109/L). Lymphopenia is not considered a DLT. A confirmed DLT requires 2 consecutive measurements separated by 48 hours.
* Grade 3 neutropenia (absolute neutrophil count \[ANC\] \<1.0 × 109/L) with elevated fever (\>101°F). A confirmed DLT requires 2 consecutive measurements.
* Grade 3 thrombocytopenia with clinically significant bleeding.
* Inability to receive the scheduled Cycle 2, Day 1 dose of study drug within 14 days due to study drug-related toxicity persisting from Cycle 1 or study drug-related toxicity newly encountered on Day 1 of Cycle 2.

National Institutes of Health (NIH)

Chimerix

Carbon Ion Boost to the Macroscopic Tumor visible on contrast-enhanced MR-Imaging

Carbon Ion Boost 18 Gy E in single Fractions of 3 Gy E

Carbon Ion Radiotherapy

Treatment standard for patients with atypical or anaplastic meningioma is neurosurgical resection. With this approach, local control ranges between 50 and 70%, depending on resection status. A series or smaller studies has shown that postoperative radiotherapy in this patient population can increase progression-free survival, which translates into increased overall survival. However, meningiomas are known to be radioresistant tumors, and radiation doses of 60 Gy or higher have been shown to be necessary for tumor control.

Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the cell line as well as the endpoint analyzed.

First data obtained within the Phase I/II trial performed at GSI in Darmstadt on carbon ion radiotherapy for patients with high-risk meningiomas has shown safety, and treatment results are promising.

Therefore, in the current Phase II-MARCIE-Study a carbon ion boost will be applied to the macroscopic tumor (gross tumor volume, GTV) in conjunction with photon radiotherapy to the clinical target volume (CTV) in patients with atypical meningiomas after incomplete resection or biopsy.

Primary endpoint is progression-free survival rate, secondary endpoints are overall survival, safety and toxicity.

Carbon Ion Radiotherapy for Atypical Meningiomas

Treatment of Patients With Atypical Meningiomas Simpson Grade 4 and 5 With a Carbon Ion Boost in Combination With Postoperative Photon Radiotherapy: A Phase II Trial

University Hospital Heidelberg

Prof. Dr. Dr. Jürgen Debus

Disease Attributes

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Immunoglobulin G

Endothelial Growth Factors

Mitogens

Immunoglobulins, Intravenous

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immunologic Factors

Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 of courses 1-4. Beginning on day 1 of course 5, patients may choose to receive bevacizumab IV every 3 weeks or remain on the every 2-week schedule. Patients also undergo electric field therapy using Optune (formerly NovoTTF-200A System) daily over 18 hours. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Undergo electric field therapy using Optune device

Electric Field Therapy

NovoTTF-200A Device

Quality-of-Life Assessment

Study Coordinator

Santosh Kesari, MD, PhD

Seema Nagpal, MD

Minesh P. Mehta, MD

Erin Dunbar, MD

Priya Kumthekar, MD

Jeffrey Raizer, MD

Karan Dixit, MD

Orin Bloch, MD

James P. Chandler, MD

Sean Grimm, MD

Richard A. Peterson, MD

Arati S. Desai, MD

The purpose of this research study is to determine the effects bevacizumab (the study drug) combined with Optune (the study device) tumor treatment field therapy has on meningiomas. Bevacizumab is considered investigational because the US Food and Drug Administration (FDA) has not approved its use for the treatment of meningiomas. The study drug is a medication that blocks the growth of new blood vessels. It is thought that the study drug may interfere with the growth of new blood vessels and therefore might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels. Optune is also considered investigational because the US FDA has not approved its use for the treatment of meningiomas. Optune is a device that the patient will wear and use for at least 18 hours of each day. It delivers alternating electrical current to the patient's brain tumor and by doing so interrupts a process called mitosis. Mitosis needs to occur in order for cell division to occur and allows tumors to grow. By slowing this process, we hypothesize that meningioma growth may also be slowed.

PRIMARY OBJECTIVES:

I. To determine progression free survival (PFS) for 6 months (PFS-6) in patients with recurrent or progressive meningioma.

SECONDARY OBJECTIVES:

I. To determine overall survival (OS). II. To determine tumor response rate (TRR). III. To assess quality of life with treatment (QOL) using Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire.

OUTLINE:

Patients receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15 of courses 1-4. Beginning on day 1 of course 5, patients may choose to receive bevacizumab IV every 3 weeks or remain on the every 2-week schedule. Patients also undergo electric field therapy using Optune (formerly NovoTTF-200A System) daily over 18 hours. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years.

Optune Delivered Electric Field Therapy and Bevacizumab in Treating Patients With Recurrent or Progressive Grade 2 or 3 Meningioma

A Phase 2, Single Arm, Multi-center, Open Label Trial Combining Optune With Concurrent Bevacizumab in the Setting of Recurrent or Progressive Meningioma

Determine the efficacy of combination therapy of bevacizumab and Optune (TTF) as assessed by Progression Free Survival at 6 months

OS will be defined from the time of registration to death and will be assessed for up to 2 years.

Imaging (MRI or CT scan) will assess radiographic response in terms of complete response, partial response, stable disease, and progressive disease. The iRANO criteria will be used for response assessment.

To assess QOL with treatment the Functional Assessment of Cancer Therapy-Brain version 4.0 (FACT-Br) questionnaire will be administered.

NovoCure Ltd.

National Cancer Institute (NCI)

Northwestern University

Guillaume GAUCHOTTE, PU-PH

Atypical meningiomas represent 15% of meningiomas. They present a high rate of recurrence, and therapeutic strategies are limited. There is a need for novel treatment strategies, such as immuotherapy.

This is a retrospective study including 84 patients with primary diagnosis of atypical meningiomas. The presence of T cells (CD4, CD8, Treg and memory T cells) and mature dendritic cells will be quantified on whole tissue sections stained by immunohistochemistry (CD4, CD8, FOXP3, CD45RO and CD208).

This could allow us to identify novel biomarkers for survival, and facilitate the selection of patients who may benefit from immunotherapeutic modalities.

Study of the Inflammatory Microenvironment in Atypical Meningiomas

Prognostic Impact of the Inflammatory Microenvironment in Atypical Meningiomas

Central Hospital, Nancy, France

PU PH

LUC BAUCHET, MD, PhD

Frank BONNETAIN

Meningiomas with malignant components include grade II meningiomas (GIIM, the most common ones) and grade III meningiomas (GIIIM). They represent 5-35% of all meningiomas. Histological diagnosis of GIIM criteria were changed in 2007 and might be viewed by some as being quite subjective. "Standards of care" and consensus do not exist for GIIM, particularly in regards to performing, or not, radiotherapy after surgery. One other limitation in the literature is lack of data on health-related quality of life (HRQoL). Clinical trials for GIIM are very difficult to conduct. No results have been made available. Here, we propose to study clinical, pathological, radiological and therapeutic factors of an exhaustive population of GIIM and GIIIM patients, at national level. The main objective (for GIIM) is to assess the impact of postoperative radiotherapy, or the absence of postoperative radiotherapy, on overall survival and on quality of life

Meningiomas with malignant components include grade II meningiomas (GIIM, the most common ones) and grade III meningiomas (GIIIM). They represent 5-35% of all meningiomas. Histological diagnosis of GIIM criteria were changed in 2007 and might be viewed by some as being quite subjective. "Standards of care" and consensus do not exist for GIIM, particularly in regards to performing, or not, radiotherapy after surgery. One other limitation in the literature is lack of data on health-related quality of life (HRQoL). Clinical trials for GIIM are very difficult to conduct. No results have been made available.

Main objective: to assess the impact of postoperative radiotherapy after GIIM surgery on overall survival (OS) in a population-setting study.

Secondary objectives (for GIIM and GIIIM):

* Evaluate the recurrence/progression free survival (PFS), volumetric velocity of the tumor growth (VVTG) after surgery and other treatment.
* Evaluate long term HRQoL.
* Evaluate the relevance and impact of histopathological review in a population setting.
* Looking for prognostic (clinical, radiological and biological) factors.
* Proposing therapeutic decision trees in general or for certain categories of patients.
* Identifying relevant cases to conduct further studies to identify new therapeutic targets.
* Perspectives for the TUCERA network to help design specific prospective projects.
* Looking for disparities in care management, survival and HRQoL in the various regions of France.

Design of the study: nationwide population-based study analysis and patterns of care/quality of care study, for all cases of incident GIIM and GIIIM operated in Metropolitan France during the 2007-2010 period.

The methodology used is based on a multidisciplinary national network already established by the French Brain Tumor DataBase (FBTDB), with the active participation of societies involved in the French neuro-oncology and the "Inter Groupe Coopérateur en Neuro-Oncologie", labeled by the French National Cancer Institute.

The FBTDB has already identified all incident cases of GIIM (n=1046) and GIIIM (n=158) operated in Metropolitan France from 2007 to 2010.

The study proposed is a retrospective study based on the medical charts of all these patients.

Furthermore, for all surviving patients not lost to follow-up, the follow-up consultations will include a prospective HRQoL evaluation (cutoff date: 2019/11/30).

It will be conducted a systematic pathological review (with eventually additional biological work-up), and a study of prognostic factors (clinical, radiological, biological), treatments administered, OS, PFS.

Primary endpoint: OS. The statistical analysis (to answer to the main question) will concern all GIIM only.

Hypothesis:

Experimental group: Group of GIIM with postoperative radiotherapy (n=314). Control group: Group of GIIM with postoperative follow-up only (n=732). With a bilateral type I error of 5% (two-sided) and a statistical power of 80% we will be able to demonstrate that postoperative radiotherapy will be associated with a Hazard ratio (mortality risk) of 0.80.

Secondary endpoints (for GIIM and GIIIM):

* PFS, VVTG after surgery and other treatment.
* HRQoL will be assessed using EORTC QLQ-C30, BN20 questionnaires, Europol EQ5D, and with a questionnaire on professional and social activities (HRQoL will be assessed for all patients alive, every six months, since inclusion, for an 18-month period).
* Mapping between HRQoL questionnaires.
* Concordance/discordance analysis between the initial histological diagnosis and the diagnosis of the pathological review.
* Conduct an inventory of cryopreserved material available for translational research.

It is expected to:

* Define subgroups of patients, according to prognostic factors, which would benefit from postoperative radiotherapy in GIIM.
* Define subgroups of patients, according to their prognostic factors, which would benefit from not having postoperative radiotherapy in GIIM.
* Propose personalized therapeutic attitudes according to prognostic factors (clinical, radiological, and biological) in general, but also for specific categories of patients such as elderly subjects.
* Define subgroups of GIIM and GIIIM that will justify conducting trials in the framework of the TUCERA network.
* Evaluate in population settings, the relevance and impact of a systematic histopathological review.
* Develop HRQoL evaluation in population settings.
* Acquire better knowledge of prognostic factors (clinical, radiological and biological) for GIIM and GIIIM, their natural history, and maybe help determine elements able to differentiate GIIM that will progress to GIIIM, from those that will remain GIIM.
* Build a clinical-biological database to identify and/or develop new therapeutic targets in GIIM and GIIIM.
* Evaluate potential disparities in terms of survival and HRQoL in the different French regions, and if some disparities are found, look for eventual causes.

Oncological Care for Patients With Meningioma

Postoperative Oncological Care for Patients With Meningioma With Malignant Components

Change from baseline in patients with a I and II grade glioma, defined by quality-of-life parameters Health related Quality of Life will be assessed using EORTC QlQ C30 and BN 20 questionnaires, Europol EQ5D, and a specific questionnaire on professional and social activities.

-EORTC QLQ-C30: Score at baseline, The change in the EORTC QLQ-C30 score from baseline to endpoint

-EORTC QLQ-BN20: Score at baseline, The change in the EORTC QLQ-C30 score from baseline to endpoint

* Europol EQ5D Score at baseline, The change in the EORTC QLQ-C30 score from baseline to endpoint
* Specific questionnaire on professional and social activities:

Score at baseline, The change in the Specific questionnaire on professional and social activities score from baseline to endpoint

Concordance/discordance analysis between the initial histological diagnosis and the diagnosis of the central pathological review.

Description: Assessing the impact of postoperative radiotherapy after surgery on overall survival (OS) in population-based study of GIIM patients. Overall survival, the primary endpoint of this study, is defined as the time from surgery (histological diagnosis) to the time of death from any cause. Alive Patients at the time of the final analysis or who became lost to follow-up will be censored at their last date of giving news

The tumor growth after surgery and other treatment (based on successive MRIs) will be determined by the volumetric velocity of the tumor growth (mm3/year)

Centre Hospitalier Universitaire de Besancon

University Hospital, Montpellier

Skin and Connective Tissue Diseases

Solitary Fibrous Tumors

Hemangiopericytoma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Pembrolizumab

Immune Checkpoint Inhibitors

IV Pembrolizumab 200mg, given every 3 weeks until disease progression or intolerable toxicity

Dror Limon, Dr

Shlomit Yust-Katz, Dr

Shlomit Yust-Katz, MD

Dror Limon, MD

A Phase II, Open-label, Single Arm Trial of Pembrolizumab for Refractory Atypical and Anaplastic Meningioma

This is a multicenter, prospective, single arm, open label, interventional study. The goal of this study, is to evaluate feasibility and efficacy of pembrolizumab for the treatment of recurrent or progressive meningioma (WHO grades II-III) or hemangiopericytoma (HPC). All patients will receive IV pembrolizumab, at a dose of 200mg, every 3 weeks. Patients will be treated until disease progression or intolerable toxicity. Treatment can be stopped after one year of treatment in case of stable disease or completer response, with re-initiation of treatment upon progression. Expression of PD1 and PD-L1 will be tested, on tumor cells, using IHC staining on biopsy material obtained from previous surgeries.

All patients will have a baseline neurologic and clinical exam, MRI scan, a brain dedicated CT-PET scan, a baseline cognitive exam and QOL assessment with a dedicated questionnaire. Patients will have a clinical and neurological exam every treatment cycle. MRI scan will be repeated after 2 months from the beginning of the trial drug administration and then every 2-3 months. There are no designated and specific criteria for response assessment in the treatment of meningioma. Therefore, response evaluation will be made using the RECIST 1.1 criteria, as used for solid tumors. The trial will allow the continuation of pembrolizumab in case of stable or improved clinical response, when pseudo-progression is suspected in the MRI. In addition, response assessment will also be made according to the RANO criteria, as used for high grade glioma. This will be compared to the RECIST evaluation, but will not be used for treatment decision making.

A Trial of Pembrolizumab for Refractory Atypical and Anaplastic Meningioma

To determine the 6 months progression free survival (PFS) rate for patients with recurrent or progressive meningioma on pembrolizumab therapy, using the RECIST 1.1 criteria.

To determine the 12 months progression free survival (PFS) rate for patients with recurrent or progressive meningioma on pembrolizumab therapy, using the RECIST 1.1 criteria.

To determine OS of patients with recurrent or progressive meningioma treated with pembrolizumab.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Multisession Radiosurgery in Residual/Recurrent Grade II Meningiomas.	NCT05081908	Meningioma Atyp...	Radiosurgery	18 Years -	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Multisession Radiosurgery in Residual/Recurrent Grade II Meningiomas.	NCT05081908	Meningioma Atyp...	Radiosurgery	18 Years -	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms	NCT04541082	Central Nervous... Glioblastoma Gliosarcoma, Ad... Anaplastic Olig... Anaplastic Astr... Pilocytic Astro... Oligodendroglio... Gliomatosis Cer... Pleomorphic Xan... Anaplastic Pleo... Diffuse Midline... Ependymoma Ependymoma, Ana... Medulloblastoma Teratoid Rhabdo... Neuroectodermal... Neuroectodermal... Anaplastic Meni... Atypical Mening... Choroid Plexus ... Pineal Tumor Diffuse Astrocy... Glial Tumor	ONC206	18 Years -	Chimerix
Carbon Ion Radiotherapy for Atypical Meningiomas	NCT01166321	Meningioma	Carbon Ion Radi...	18 Years -	University Hospital Heidelberg
Optune Delivered Electric Field Therapy and Bevacizumab in Treating Patients With Recurrent or Progressive Grade 2 or 3 Meningioma	NCT02847559	Anaplastic (Mal... Atypical Mening... Grade II Mening... Grade III Menin... Recurrent Menin... Supratentorial ...	Bevacizumab Electric Field ... NovoTTF-200A De... Quality-of-Life...	18 Years -	Northwestern University
Study of the Inflammatory Microenvironment in Atypical Meningiomas	NCT04761653	Atypical Mening...		18 Years -	Central Hospital, Nancy, France
Oncological Care for Patients With Meningioma	NCT02973256	Atypical Mening... Clear-cell Meni... Chordoid Mening... Anaplastic Meni... Rhabdoid Mening... Papillary Menin...		-	University Hospital, Montpellier
A Trial of Pembrolizumab for Refractory Atypical and Anaplastic Meningioma	NCT03016091	Atypical Mening... Anaplastic Meni... Hemangiopericyt...	Pembrolizumab	18 Years -	Rabin Medical Center

Spots Global Cancer Trial Database for atypical meningioma