Trial Outcomes & Findings for A Trial of Pembrolizumab for Refractory Atypical and Anaplastic Meningioma (NCT NCT03016091)
NCT ID: NCT03016091
Last Updated: 2025-02-18
Results Overview
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.
TERMINATED
PHASE2
18 participants
6 months after starting treatment
2025-02-18
Participant Flow
18 adult patients with histologically or radiologically proven recurrent or progressive meningioma (grade I to III) or anaplastic SFT who were treated in a single institution from 2018 to 2022 (15 patients with recurrent meningioma and 3 with anaplastic SFT). Patients were recruited at least 6 months after treatment with stereotactic radiosurgery.
Participant milestones
| Measure |
Arm 1
IV Pembrolizumab 200mg, given every 3 weeks until disease progression, intolerable toxicity or up to 2 years of treatment.
Pembrolizumab: anti PD-L1 18 patients received treatment
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of Pembrolizumab for Refractory Atypical and Anaplastic Meningioma
Baseline characteristics by cohort
| Measure |
Arm 1
n=18 Participants
IV Pembrolizumab 200mg, given every 3 weeks until disease progression, intolerable toxicity or up to 2 years of treatment.
Pembrolizumab: anti PD-L1 18 patients received treatment
|
|---|---|
|
Age, Customized
|
64.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
KPS at baseline
|
60 units on a scale
n=5 Participants
|
|
Tumor type
Recurrent grade I meningioma
|
3 Participants
n=5 Participants
|
|
Tumor type
Atypical meningioma
|
11 Participants
n=5 Participants
|
|
Tumor type
Anaplastic meningioma
|
1 Participants
n=5 Participants
|
|
Tumor type
Anaplastic solitary fibrous tumor
|
3 Participants
n=5 Participants
|
|
Multifocal disease
|
14 Participants
n=5 Participants
|
|
Number of previous surgeries
|
3 surgeries
n=5 Participants
|
|
Number of previous radiation therapy courses
|
2 radiation therapy courses
n=5 Participants
|
|
Number of previous systemic therapies
|
0 systemic therapies
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months after starting treatmentPopulation: all participants who were assigned to the group
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.
Outcome measures
| Measure |
Arm 1
n=18 Participants
IV Pembrolizumab 200mg, given every 3 weeks until disease progression, intolerable toxicity or up to 2 years of treatment.
Pembrolizumab: anti PD-L1 18 patients received treatment
|
|---|---|
|
Progression Free Survival (PFS)
|
2 Participants
|
PRIMARY outcome
Timeframe: 12 months after starting treatmentPopulation: all participants who were assigned to the group
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.
Outcome measures
| Measure |
Arm 1
n=18 Participants
IV Pembrolizumab 200mg, given every 3 weeks until disease progression, intolerable toxicity or up to 2 years of treatment.
Pembrolizumab: anti PD-L1 18 patients received treatment
|
|---|---|
|
Progression Free Survival (PFS)
|
2 Participants
|
SECONDARY outcome
Timeframe: from date of diagnosis until date of death from any causePopulation: all participants who were assigned to the group
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.
Outcome measures
| Measure |
Arm 1
n=18 Participants
IV Pembrolizumab 200mg, given every 3 weeks until disease progression, intolerable toxicity or up to 2 years of treatment.
Pembrolizumab: anti PD-L1 18 patients received treatment
|
|---|---|
|
Overall Survival (OS)
|
40 month
Interval 2.0 to
several patients were still alive at the end of the study
|
SECONDARY outcome
Timeframe: From the initiation of treatment to the occurrence of disease progression or death.Population: all participants who were assigned to the group
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.
Outcome measures
| Measure |
Arm 1
n=18 Participants
IV Pembrolizumab 200mg, given every 3 weeks until disease progression, intolerable toxicity or up to 2 years of treatment.
Pembrolizumab: anti PD-L1 18 patients received treatment
|
|---|---|
|
Overall Progression Free Survival (PFS)
|
2.2 month
Interval 1.9 to 27.0
|
Adverse Events
Arm 1
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1
n=18 participants at risk
IV Pembrolizumab 200mg, given every 3 weeks until disease progression, intolerable toxicity or up to 2 years of treatment.
Pembrolizumab: anti PD-L1 18 patients received treatment
|
|---|---|
|
General disorders
Fatigue
|
5.6%
1/18 • 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.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.6%
1/18 • 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.
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
1/18 • 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.
|
Additional Information
Shlomit Yust-Katz MD
Davidoff Cancer Center at Rabin Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place