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Checkpoint Inhibitor
Pembrolizumab for Brain Tumor
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months and 6 months
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
This trial is testing a drug that may treat cancer spread to the brain/spine.
Who is the study for?
This trial is for adults with confirmed solid tumor metastases in the brain or spinal cord. Participants must have a measurable lesion, be in good physical condition (ECOG ≤2), and have a life expectancy over 6 weeks. Specific cohorts include untreated asymptomatic brain metastases, carcinomatous meningitis, and melanoma with limited brain metastases suitable for radiosurgery.
What is being tested?
The study tests Pembrolizumab's effectiveness on central nervous system metastases from various tumors. It includes MRI and PET/CT imaging to track changes, along with Stereotactic Radiosurgery for certain patients. The trial has multiple cohorts based on different disease characteristics.
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation of organs, infusion reactions like fever or chills, fatigue, skin rash, digestive issues including diarrhea or liver problems, hormonal gland problems leading to hormone imbalances.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months and 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Extracranial Overall Response Rate
Objective Response Rate
Secondary study objectives
Extracranial Response Rate
Intracranial Response Rate
Overall Survival Rate
Side 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%
Clostridium difficile colitis
1%
Systemic infection
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
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Progressive Brain Metastases-Cohort BExperimental Treatment3 Interventions
- Progressive Brain Metastases
* Baseline Brain MRI and PET CT
* For all cohorts, pembrolizumab will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle. Treatment will be administered on an outpatient basis.
* Brain MRI and PET/CT
Group II: Previously Untreated Brain Metastases-Cohort AExperimental Treatment3 Interventions
- Previously Untreated Brain Metastases
* Baseline Brain MRI and PET CT
* For all cohorts, pembrolizumab will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle. Treatment will be administered on an outpatient basis.
* Brain MRI and PET/CT
Group III: Neoplastic Meningitis-Cohort CExperimental Treatment3 Interventions
* Neoplastic Meningitis
* Histologically confirmed solid malignancy
* Positive Cytology
* Baseline Brain MRI
* For all cohorts, pembrolizumab will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle. Treatment will be administered on an outpatient basis.
* Brain MRI and PET/CT
Group IV: 1-4 Brain Metastases from Melanoma Cohort DExperimental Treatment4 Interventions
* 1-4 Brain Metastases from Melanoma
* Clinical indication for stereostatic radiosurgery
* Evaluable extracranial focus
* For all cohorts, pembrolizumab will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle. In Cohort D, cycle 1 and 2 of pembrolizumab will be administered 3 weeks apart and stereotactic radiosurgery will be administered between cycles. Treatment will be administered on an outpatient basis.
* Brain MRI and PET CT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Stereotactic Radiosurgery
2021
Completed Phase 2
~440
PET/CT
2022
Completed Phase 3
~1300
MRI
2009
Completed Phase 2
~2810
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,181 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,001 Previous Clinical Trials
5,184,810 Total Patients Enrolled
Priscilla Brastianos, MDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
6 Previous Clinical Trials
404 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have surgery or radiation treatment for brain metastases right away.You have had chemotherapy or other specific treatments within the last 14 days, or you have not fully recovered from side effects of previous treatments.You have a condition that weakens your immune system.You have taken a high dose of dexamethasone (more than 2mg per day) in the past week.You have known mental health or drug abuse problems.You recently had bleeding in your brain and are experiencing symptoms.You have another type of cancer that is getting worse or needs ongoing treatment.You have a condition where your immune system attacks your own body and needed strong medication for it in the past 2 years.You have a history of lung inflammation that is not caused by an infection.You have a current infection that needs strong medication to treat.You have received treatment with a specific type of medication that targets the PD-1, PD-L1, or PD-L2 proteins before.You currently have active Hepatitis B or Hepatitis C.You cannot have a brain MRI.You are currently getting other types of treatment for your cancer, like chemotherapy or immunotherapy.You must have a confirmed diagnosis of cancer from a tissue sample or cells.You must have a detectable brain tumor that can be accurately measured and is at least 5 millimeters in size.You have HIV and are taking multiple medications to treat it.You have not received treatment for brain tumors and do not show any symptoms related to them for Cohort A.You have a measurable brain lesion that is at least 5 millimeters in size.You have cancer that has spread to the covering of the brain and spinal cord.You have between 1 to 4 brain metastases, and your doctor may recommend a treatment called stereotactic radiosurgery for them.You have been diagnosed with melanoma through a tissue sample.You have taken medication that weakens your immune system in the past three months.You are allergic to pembrolizumab or any of the ingredients in it.You are able to perform everyday activities without help, or with a little help.You are expected to live for at least 6 more weeks.Your organs and bone marrow are working normally based on recent tests.You have been taking 2mg or less of dexamethasone each day for the past week.Patients with worsening overall health may not participate.You can join the study even if you have cancer that has spread to your spine, as long as it's not causing any symptoms.You can participate if you have small and symptom-free brainstem metastases that have not been treated yet.You have a brain lesion that is at least 5 millimeters in size.You have brain tumors that have gotten worse after getting treatment like radiation or surgery.You have a current case of tuberculosis.
Research Study Groups:
This trial has the following groups:- Group 1: 1-4 Brain Metastases from Melanoma Cohort D
- Group 2: Previously Untreated Brain Metastases-Cohort A
- Group 3: Progressive Brain Metastases-Cohort B
- Group 4: Neoplastic Meningitis-Cohort C
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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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