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Monoclonal Antibodies
Pembrolizumab for High-Grade Meningioma
Phase 2
Waitlist Available
Led By Priscilla Brastianos, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with measurable and progressive meningioma who have received radiation and show evidence of progressive disease in the radiated field after completion of radiation
ECOG Performance Status < 2
Must not have
Participants with brainstem lesions
Participants who have had chemotherapy, targeted small molecule therapy or study therapy within 14 days of protocol treatment, or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 35 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is studying pembrolizumab to see how well it works in treating patients with high grade meningioma.
Who is the study for?
This trial is for adults with recurrent or residual high-grade meningioma. Candidates can have had previous treatments but must show measurable disease progression post-radiation, if applicable. They should be in good physical condition (ECOG Performance Status < 2), not pregnant or nursing, and on a stable low dose of dexamethasone. People with brainstem lesions, active infections, certain psychiatric conditions, recent immunosuppressive treatments, known hypersensitivity to pembrolizumab or its components are excluded.
What is being tested?
The study tests Pembrolizumab's effectiveness for treating high-grade meningioma that has recurred after treatment or remains after surgery. Participants will receive this immunotherapy drug to see how it affects their cancer compared to the standard care they would otherwise receive.
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver problems, skin reactions, hormone gland issues (like thyroid dysfunction), and could potentially worsen pre-existing autoimmune diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My meningioma has grown after I completed radiation therapy.
Select...
I can do most of my daily activities without help.
Select...
My meningioma has come back or spread beyond its original location.
Select...
I've been on a stable dose of dexamethasone (2mg or less) for the last week.
Select...
My cancer has grown by 25% or more in less than 2 years.
Select...
I have a Grade II or III meningioma with measurable disease after surgery.
Select...
My meningioma has come back or spread beyond its original location.
Select...
My meningioma has spread beyond the brain.
Select...
My MRI shows a tumor in my brain that's at least 10mm big after surgery.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a lesion in my brainstem.
Select...
I haven't had cancer treatment or recovered from its side effects in the last 2 weeks.
Select...
I have been diagnosed with an immunodeficiency.
Select...
I need to take more than 2mg/day of dexamethasone before starting therapy.
Select...
I have an active tuberculosis infection.
Select...
I do not have any unmanaged ongoing illnesses.
Select...
I have an autoimmune disease treated with medication in the last 2 years.
Select...
I have a history of lung inflammation not caused by an infection.
Select...
I am currently being treated for an infection.
Select...
I have been diagnosed with HIV.
Select...
I have an active Hepatitis B or C infection.
Select...
I have not received a live vaccine in the last 30 days.
Select...
I have another cancer that is getting worse or needs treatment.
Select...
I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 35 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 35 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free Survival at 6 Months (PFS6)
Secondary study objectives
Number of Participants With Intracranial Response
Overall Survival (OS)
Overall Survival (OS) at 3 Months
+2 moreSide effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PembrolizumabExperimental Treatment1 Intervention
* Pembrolizumab will be administered every 3 weeks
* Pembrolizumab will be administered through IV infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
4,015 Previous Clinical Trials
5,186,307 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
3,015 Previous Clinical Trials
13,309,334 Total Patients Enrolled
Priscilla Brastianos, MDPrincipal InvestigatorMassachusetts General Hospital
6 Previous Clinical Trials
479 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received treatment before.My meningioma has grown after I completed radiation therapy.I can do most of my daily activities without help.I have not taken drugs that weaken my immune system in the last 3 months.My meningioma has come back or spread beyond its original location.I have a lesion in my brainstem.You have a measurable main lesion that is at least 10 millimeters in size and can be clearly seen on MRI or CT scans.I have had multiple treatments for my condition.I've been on a stable dose of dexamethasone (2mg or less) for the last week.I have stable brain tumors for 6 months due to NF.My cancer has grown by 25% or more in less than 2 years.I have a growing meningioma after radiation, and it's been 24 weeks or my tumor is growing outside the treated area.I have a tumor that can be clearly seen and measured on an MRI or CT scan.I may or may not have had previous medical treatments.My meningioma was caused by previous radiation treatments.I haven't had cancer treatment or recovered from its side effects in the last 2 weeks.I have been diagnosed with an immunodeficiency.I have an autoimmune disease treated with medication in the last 2 years.I have a history of lung inflammation not caused by an infection.I am currently being treated for an infection.I have been diagnosed with HIV.I have an active Hepatitis B or C infection.I have not received a live vaccine in the last 30 days.I have a Grade II or III meningioma with measurable disease after surgery.I may or may not have had previous medical treatments.I agree to use contraception during the study.I need to take more than 2mg/day of dexamethasone before starting therapy.I have an active tuberculosis infection.I do not have any unmanaged ongoing illnesses.I have another cancer that is getting worse or needs treatment.My meningioma has come back or spread beyond its original location.You are allergic to pembrolizumab or any of its ingredients.I have had multiple treatments for my condition.You cannot have a brain MRI scan.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.My meningioma has spread beyond the brain.You have a diagnosed mental health condition or issues with substance abuse.My recent tests show my organs and bone marrow are functioning well.My MRI shows a tumor in my brain that's at least 10mm big after surgery.Your main tumor has gotten at least 25% bigger on imaging.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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