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Monoclonal Antibodies
Focused Ultrasound + Immunotherapy for Brain Cancer
Phase 3
Recruiting
Led By Manmeet Ahluwalia, MD, MBA
Research Sponsored by InSightec
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female subject is confirmed NOT PREGNANT each procedure day. Male and Female subjects are utilizing highly effective contraception during the study and through 120 days (4 months) after the study
Participant is ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study Summary
This trial is testing a new way to treat brain cancer that involves breaking down the barrier that protects the brain. They will do this in patients who are also receiving immunotherapy.
Who is the study for?
Adults with non-small cell lung cancer (NSCLC) brain metastases, not pregnant, willing to use contraception and comply with study procedures. Must have EGFR/ALK-negative tumors, measurable untreated brain metastasis accessible by MRI, good performance status (Karnofsky ≥70% or ECOG 0-2), and prescribed pembrolizumab. Excludes those with bleeding risks, certain infections like hepatitis/HIV/TB, severe medical disorders, known allergies to trial substances, contraindications to MRI/gadolinium-DTPA or pembrolizumab.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of disrupting the blood-brain barrier using Exablate Focused Ultrasound in combination with standard pembrolizumab therapy for treating NSCLC brain metastases. The goal is to see if this approach can improve treatment outcomes.See study design
What are the potential side effects?
Potential side effects may include discomfort from focused ultrasound procedure, allergic reactions to contrast agents used during MRI scans or medications involved in the study. Pembrolizumab can cause immune-related adverse effects such as inflammation in organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant and will use effective birth control during and 4 months after the study.
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I am 18 years old or older.
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I am being treated with pembrolizumab for non-small cell lung cancer.
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I have a brain tumor larger than 0.5 cm that hasn't been treated yet.
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My cancer does not have EGFR or ALK markers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events
tumor lesion(s) on the MRI images
Secondary outcome measures
Time to response for brain metastases by treatment arm
evaluation of Neuro Oncology Brain Mets (RANO-BM) response
time to response for brain mets by treatment arm
Other outcome measures
Measurement of BBBD disruption
Patient reported quality of life measurement questionnaires
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab with Exablate BBBDExperimental Treatment2 Interventions
Using Exablate Model 4000 Type 2 for the treatment of NSCLC brain metastases in subjects who are undergoing planned pembrolizumab monotherapy.
Group II: Control Arm (Pembrolizumab only)Active Control1 Intervention
subjects will undergo planned pembrolizumab monotherapy.
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?
InSightecLead Sponsor
89 Previous Clinical Trials
3,694 Total Patients Enrolled
Manmeet Ahluwalia, MD, MBAPrincipal InvestigatorMiami Cancer Institute, Baptist Health South Florida
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic or cannot take pembrolizumab due to severe reactions.I am not pregnant and will use effective birth control during and 4 months after the study.I have not received a live vaccine in the last 28 days.I have an autoimmune disease treated in the last 2 years or currently have pneumonitis.I have a chronic viral infection like Hepatitis or HIV, or a history of active TB.I have an infection in my brain or elsewhere in my body.I am allergic to DEFINITY® or its ingredients like polyethylene glycol.I can take care of myself and perform normal activities.I have had an organ or stem cell transplant.I am 18 years old or older.I don't have a bleeding disorder or recent use of certain blood-thinning meds.I have another cancer that is getting worse or was treated in the last 3 years.My cancer has spread to the lining of my brain and spinal cord.I am being treated with pembrolizumab for non-small cell lung cancer.I have bleeding or significant calcifications in my brain where ultrasound treatment is planned.I am at risk for brain bleeding due to my cancer type.My kidney function is severely impaired, with low filtration rates or I am on dialysis.I have a brain tumor larger than 0.5 cm that hasn't been treated yet.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have symptoms like headaches or vision changes due to increased pressure in my brain.I am currently taking medication that increases my risk of bleeding.My cancer does not have EGFR or ALK markers.I do not have severe liver problems like cirrhosis or active hepatitis.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm (Pembrolizumab only)
- Group 2: Pembrolizumab with Exablate BBBD
Awards:
This trial has 3 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you give me a ballpark number of how many places this trial is happening?
"There are 4 recruiting patients for this trial including Sunnybrook Research Institute in Toronto, St. Joseph's Hospital and Medical Center in Phoenix, and University of Maryland in Baltimore, along with other locations."
Answered by AI
Are octogenarians eligible for this clinical trial?
"Based on the age restrictions listed in the inclusion criteria, the minimum age to participate in this clinical trial is 18 and the maximum age is 100."
Answered by AI
Has the FDA cleared Pembrolizumab in combination with Exablate BBBD for patient use?
"Pembrolizumab with Exablate BBBD is considered to be safe (scoring a 3 on our 1-to-3 scale) because it has progressed to Phase 3 clinical trials. This means that not only is there some evidence of its efficacy, but also that there have been multiple rounds of testing confirming its safety."
Answered by AI
Who meets the selection criteria for this clinical trial?
"This clinical study is seeking 20 patients with brain neoplasms who are between the ages of 18 and 100. In addition to meeting this age criteria, participants must also meet the following requirements: The participant provides written informed consent for the trial, Participant is willing to comply with all study procedures for the duration of the study, Screening/Baseline laboratory values, Subject has tumor biomarkers that are EGFR (epidermal growth factor receptor) and ALK (anaplastic lymphoma kinase) negative, Participant is a NSCLC subject prescribed pembrolizumab monotherapy per standard of care, Participant is"
Answered by AI
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