Trial · NCT03016091
A Trial of Pembrolizumab for Refractory Atypical and Anaplastic Meningioma
NCT03016091, Phase 2, Terminated, Rabin Medical Center; results first posted 2025-01-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial of Pembrolizumab for Refractory Atypical and Anaplastic Meningioma. Trials, record NCT03016091. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03016091
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of Pembrolizumab for Refractory Atypical and Anaplastic Meningioma
- NCT number
- NCT03016091
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Rabin Medical Center
- Conditions
- Atypical Meningioma, Anaplastic Meningioma, Hemangiopericytoma
- Interventions
- Pembrolizumab
- First posted
- 2017-01-10
- Last updated
- 2025-02-18
- Results first posted
- 2025-01-22
- Limitations and caveats
Twenty-five patients were required for the analysis to have 80% power to detect improvement in PFS-6 from 5% to 25% with a significance level of 0.05, and accounting for a 10% drop-out rate. The study was terminated after accrual of 18 patients, due to slow accrual and lack of efficacy
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | 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. Partial response (PR) with a 50% or more reduction in tumor size. Minor response (MR) between 25% to 50% reduction in tumor size. Stable disease (SD) indicating minimal change, and progressive disease (PD) defined by at least a 25% increase in tumor size, new lesions, or worsening clinical symptoms. these criteria emphasize the use of consistent imaging techniques such as MRI. |
| Primary | Progression Free Survival (PFS) | 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. Partial response (PR) with a 50% or more reduction in tumor size. Minor response (MR) between 25% to 50% reduction in tumor size. Stable disease (SD) indicating minimal change, and progressive disease (PD) defined by at least a 25% increase in tumor size, new lesions, or worsening clinical symptoms. these criteria emphasize the use of consistent imaging techniques such as MRI. |
| Secondary | Overall Survival (OS) | 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. |
| Secondary | Overall Progression Free Survival (PFS) | 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 size. Stable disease (SD) indicating minimal change, and progressive disease (PD) defined by at least a 25% increase in tumor size, new lesions, or worsening clinical symptoms. these criteria emphasize the use of consistent imaging techniques such as MRI. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | 6 months after starting treatment | all participants who were assigned to the group | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Progression Free Survival (PFS) | 12 months after starting treatment | all participants who were assigned to the group | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | from date of diagnosis until date of death from any cause | all participants who were assigned to the group | month | MEDIAN |
| SECONDARY | Overall Progression Free Survival (PFS) | From the initiation of treatment to the occurrence of disease progression or death. | all participants who were assigned to the group | month | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Arm 1 | 2 | Participants | ||
| Progression Free Survival (PFS) | Arm 1 | 2 | Participants | ||
| Overall Survival (OS) | Arm 1 | 40 | Full Range 2 to NA | month | |
| Overall Progression Free Survival (PFS) | Arm 1 | 2.2 | Full Range 1.9 to 27 | month |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 | 18 | |
| Overall Study | COMPLETED | Arm 1 | 18 | |
| Overall Study | NOT COMPLETED | Arm 1 | 0 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Arm 1 | 1 | 18 | |
| other | Hyperglycemia | Metabolism and nutrition disorders | Arm 1 | 1 | 18 | |
| other | Diarrhea | Gastrointestinal disorders | Arm 1 | 1 | 18 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 | 4 | 18 |
| Total, other adverse events | Arm 1 | 3 | 18 |
| Total, serious adverse events | Arm 1 | 0 | 18 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03016091
GET https://conductscience.org/api/trials/v1/NCT03016091/registered