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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
Must not have
Contraindications to pembrolizumab or has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
Participant has received a live vaccine within 28 days prior to the first dose of study agent Examples of live vaccines include, but are not limited to measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), typhoid vaccine, and intranasal influenza vaccines (e.g., FluMist®)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
All Individual Drugs Already Approved

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic or cannot take pembrolizumab due to severe reactions.
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I have not received a live vaccine in the last 28 days.
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I have an autoimmune disease treated in the last 2 years or currently have pneumonitis.
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I have a chronic viral infection like Hepatitis or HIV, or a history of active TB.
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I have an infection in my brain or elsewhere in my body.
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I am allergic to DEFINITY® or its ingredients like polyethylene glycol.
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I have had an organ or stem cell transplant.
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I don't have a bleeding disorder or recent use of certain blood-thinning meds.
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My cancer has spread to the lining of my brain and spinal cord.
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I have bleeding or significant calcifications in my brain where ultrasound treatment is planned.
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I am at risk for brain bleeding due to my cancer type.
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My kidney function is severely impaired, with low filtration rates or I am on dialysis.
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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
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I have symptoms like headaches or vision changes due to increased pressure in my brain.
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I am currently taking medication that increases my risk of bleeding.
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I do not have severe liver problems like cirrhosis or active hepatitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events
tumor lesion(s) on the MRI images
Secondary study objectives
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 study objectives
Measurement of BBBD disruption
Patient reported quality of life measurement questionnaires

Awards & Highlights

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.
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

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
91 Previous Clinical Trials
3,778 Total Patients Enrolled
Manmeet Ahluwalia, MD, MBAPrincipal InvestigatorMiami Cancer Institute, Baptist Health South Florida

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05317858 — Phase 3
Brain Tumor Research Study Groups: Control Arm (Pembrolizumab only), Pembrolizumab with Exablate BBBD
Brain Tumor Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05317858 — Phase 3
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05317858 — Phase 3
~6 spots leftby Dec 2025
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