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NCT03016091

A Trial of Pembrolizumab for Refractory Atypical and Anaplastic Meningioma

Terminated Phase 2 Results posted Last updated 18 February 2025
What this trial tests

Phase 2 trial testing Pembrolizumab in Atypical Meningioma in 18 participants. Terminated before completion.

Timeline
1 January 2018
Primary endpoint
1 July 2022
1 December 2022

Quick facts

Lead sponsorRabin Medical Center
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment18
Start date1 January 2018
Primary completion1 July 2022
Estimated completion1 December 2022
Sites2 locations across Israel

Drugs / interventions tested

Conditions studied

Sponsor

Rabin Medical Center

Who can join

Adults 18 to 85, any sex, with Atypical Meningioma or Anaplastic Meningioma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression Free Survival (PFS) Primary · 6 months after starting treatment

6 months PFS refers to the percentage of patients in a study who remain alive and whose disease has not worsened 6 months after starting treatment. To determine the 6 months PFS rate for patients with recurrent or progressive meningioma on pembrolizumab therapy we used the RANO meningioma criteria. The Response Assessment in Neuro-Oncology meningioma criteria are guidelines used to evaluate treatment response in meningioma patients, incorporating both radiological and clinical factors. Tumor response is classified into categories such as: complete response (CR), where the tumor disappears. Pa

GroupValue95% CI
Arm 12
Progression Free Survival (PFS) Primary · 12 months after starting treatment

12 months PFS refers to the percentage of patients in a study who remain alive and whose disease has not worsened 12 months after starting treatment. To determine the 12 months PFS rate for patients with recurrent or progressive meningioma on pembrolizumab therapy we used the RANO meningioma criteria. The Response Assessment in Neuro-Oncology meningioma criteria are guidelines used to evaluate treatment response in meningioma patients, incorporating both radiological and clinical factors. Tumor response is classified into categories such as: complete response (CR), where the tumor disappears.

GroupValue95% CI
Arm 12
Overall Survival (OS) Secondary · from date of diagnosis until date of death from any cause

Overall survival (OS) is a term used in reference to treatments for cancer. It refers to the time which begins at diagnosis and up to the time of death.

GroupValue95% CI
Arm 1402 – NA
Overall Progression Free Survival (PFS) Secondary · From the initiation of treatment to the occurrence of disease progression or death.

To determine the overall progression free survival (PFS) rate for patients with recurrent or progressive meningioma on pembrolizumab therapy we used the RANO meningioma criteria. The Response Assessment in Neuro-Oncology meningioma criteria are guidelines used to evaluate treatment response in meningioma patients, incorporating both radiological and clinical factors. Tumor response is classified into categories such as: complete response (CR), where the tumor disappears. Partial response (PR) with a 50% or more reduction in tumor size. Minor response (MR) between 25% to 50% reduction in tumor

GroupValue95% CI
Arm 12.21.9 – 27

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious and other (Not Including Serious) Adverse Events were assessed from the beginning of treatment for up to two year, and all-cause mortality were assessed from the diagnosis until 1/12/2022.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm 1
Serious: 0/18 (0%)
Deaths: 4/18
Other adverse events (3 terms — click to expand)

ReactionSystemArm 1
FatigueGeneral disorders
HyperglycemiaMetabolism and nutrition disorders
DiarrheaGastrointestinal disorders

Data from ClinicalTrials.gov NCT03016091 adverse events section.

Sponsor's own description

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

Publications & conference data

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

  1. An overview of meningiomas.
    Buerki RA, Horbinski CM, Kruser T, Horowitz PM, et al · · 2018 · cited 325× · PMID 30084265 · DOI 10.2217/fon-2018-0006
  2. 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
  3. Meningioma: not always a benign tumor. A review of advances in the treatment of meningiomas.
    Maggio I, Franceschi E, Tosoni A, Nunno VD, et al · · 2021 · cited 100× · PMID 34015955 · DOI 10.2217/cns-2021-0003
  4. Meningioma: A Review of Clinicopathological and Molecular Aspects.
    Huntoon K, Toland AMS, Dahiya S. · · 2020 · cited 96× · PMID 33194703 · DOI 10.3389/fonc.2020.579599
  5. 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
  6. Basis for Immunotherapy for Treatment of Meningiomas.
    Garzon-Muvdi T, Bailey DD, Pernik MN, Pan E. · · 2020 · cited 46× · PMID 32982948 · DOI 10.3389/fneur.2020.00945
  7. Identification of PD-L2, B7-H3 and CTLA-4 immune checkpoint proteins in genetic subtypes of meningioma.
    Proctor DT, Patel Z, Lama S, Resch L, et al · · 2019 · cited 42× · PMID 30546952 · DOI 10.1080/2162402x.2018.1512943
  8. Recent Advances in Meningioma Immunogenetics.
    Al-Rashed M, Foshay K, Abedalthagafi M. · · 2019 · cited 39× · PMID 31970090 · DOI 10.3389/fonc.2019.01472

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing