Trial · NCT03279692
Phase II Trial of Pembrolizumab in Recurrent or Residual High Grade Meningioma
NCT03279692, Phase 2, Active not recruiting, Massachusetts General Hospital; results first posted 2023-06-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Trial of Pembrolizumab in Recurrent or Residual High Grade Meningioma. Trials, record NCT03279692. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03279692
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Trial of Pembrolizumab in Recurrent or Residual High Grade Meningioma
- NCT number
- NCT03279692
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- High Grade Meningioma
- Interventions
- Pembrolizumab
- First posted
- 2017-09-12
- Last updated
- 2026-10-21
- Results first posted
- 2023-06-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival at 6 Months (PFS6) | up to 6 months | Progression-free survival at 6 months is defined as not having disease progression per RANO (response assessment in neuro-oncology) criteria or death from any cause within six months of the first day of treatment with pembrolizumab. Contrast-enhanced cranial magnetic resonance imaging (MRI) was performed every 6 weeks to assess patient response to treatment. Progressive disease is defined per RANO criteria as the appearance of a new lesion, an increase in the size of a patient's existing lesions, or clear clinical worsening (seizures, medication side effects, complications of therapy, cerebrovascular events, infection, etc.) |
| Secondary | Overall Survival (OS) | Up to 35 months | OS is defined as the time from protocol registration until death due to any cause. The follow-up of patients who were alive at the time of analysis was censored at the date of last assessment of vital status. 90% confidence intervals for median OS were estimated using log(-log(survival)) methodology. |
| Secondary | Overall Survival (OS) at 3 Months | 3 months | OS benchmarked at 3 months measures the percentage of participants who are still alive at 3 months, after study registration and receiving study therapy. |
| Secondary | Overall Survival (OS) at 6 Months | 6 months | OS benchmarked at 6 months measures the percentage of participants who are still alive at 6 months, after study registration and receiving study therapy. |
| Secondary | Percentage of Participants With Treatment-related Adverse Events | Up to 26 months | All adverse events (AEs) recorded during the trial were summarized for all patients who received one or more doses of pembrolizumab. This outcome measure includes adverse events assessed as at least possibly related to study therapy and grade 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE) version 4. |
| Secondary | Number of Participants With Intracranial Response | Up to 25 months | Intracranial response is defined as complete response (CR), partial response (PR), or stable disease (SD) by RANO (response assessment for neuro-oncology) criteria. Intracranial response was assessed by contrast-enhanced cranial magnetic resonance imaging (MRI) every 6 weeks. CR: complete disappearance of all enhancing measurable and non-measurable disease sustained for 4+ weeks, no new lesions, stable/decreasing corticosteroids, and patient is stable and improved clinically. Participants with non-measurable disease cannot have a CR; the best possible response is SD. PR: greater than or equal to 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for 4+ weeks, no progression of non-measurable disease, no new lesions, stable/decreasing corticosteroids, and patient is stable or improved clinically. SD: does not qualify for CR, PR, or disease progression and patient is stable clinically. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival at 6 Months (PFS6) | up to 6 months | percent of participants | NUMBER | |
| SECONDARY | Overall Survival (OS) | Up to 35 months | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) at 3 Months | 3 months | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival (OS) at 6 Months | 6 months | percent of patients | NUMBER | |
| SECONDARY | Percentage of Participants With Treatment-related Adverse Events | Up to 26 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Intracranial Response | Up to 25 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival at 6 Months (PFS6) | Pembrolizumab | 48 | 90% Confidence Interval 31 to 66 | percent of participants | |
| Overall Survival (OS) | Pembrolizumab | 20.2 | 90% Confidence Interval 14.8 to 25.8 | months | |
| Overall Survival (OS) at 3 Months | Pembrolizumab | 92 | 90% Confidence Interval 77 to 97 | percentage of participants | |
| Overall Survival (OS) at 6 Months | Pembrolizumab | 84 | 90% Confidence Interval 67 to 93 | percent of patients | |
| Percentage of Participants With Treatment-related Adverse Events | Pembrolizumab | 20 | Participants | ||
| Number of Participants With Intracranial Response | Pembrolizumab | Complete Response | 0 | Participants | |
| Number of Participants With Intracranial Response | Pembrolizumab | Partial Response | 0 | Participants | |
| Number of Participants With Intracranial Response | Pembrolizumab | Stable Disease | 18 | Participants |
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 | Pembrolizumab | 26 | |
| Overall Study | COMPLETED | Pembrolizumab | 25 | |
| Overall Study | NOT COMPLETED | Pembrolizumab | 1 |
Source ClinicalTrials.gov
Adverse events192
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 | Adrenal Insufficiency | Endocrine disorders | Pembrolizumab | 1 | 25 | 1 |
| other | Alanine aminotransferase increased | Investigations | Pembrolizumab | 4 | 25 | 4 |
| other | Alkaline phosphatase increased | Investigations | Pembrolizumab | 4 | 25 | 4 |
| other | Alopecia | Investigations | Pembrolizumab | 1 | 25 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Pembrolizumab | 7 | 25 | 11 |
| other | Anorexia | Metabolism and nutrition disorders | Pembrolizumab | 2 | 25 | 2 |
| other | Anxiety | Psychiatric disorders | Pembrolizumab | 3 | 25 | 3 |
| other | Aspartate Aminotransferase Increased | Investigations | Pembrolizumab | 3 | 25 | 3 |
| other | Ataxia | Nervous system disorders | Pembrolizumab | 1 | 25 | 1 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Pembrolizumab | 4 | 25 | 7 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab | 15 | 25 |
| Total, other adverse events | Pembrolizumab | 25 | 25 |
| Total, serious adverse events | Pembrolizumab | 10 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35289329 | DERIVED |
Source PubMed
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/NCT03279692
GET https://conductscience.org/api/trials/v1/NCT03279692/events?page=2