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New treatment option for Brain Tumor
Official title Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets
ClinicalTrials.gov ID: NCT05317858
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for brain tumor.
Also referred to as KEYTRUDA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier opening with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned FDA approved, on-label systemic therapy utilizing immune checkpoint inhibitors.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Participant is ≥ 18 years of age
- The participant provides written informed consent for the trial
- Participant is willing to comply with all study procedures for the duration of the study
- Participant has a Karnofsky Performance Status ≥ 70% and/or ECOG 0-2
- Participant is a NSCLC subject prescribed immune checkpoint inhibitor systemic therapy according to on-label use with the target brain lesion(s)...
You likely can't join if
- Participant has evidence of acute intracranial hemorrhage
- Participant at risk for spontaneous intracranial hemorrhage (e.g., history of metastatic melanoma or other tissue histology).
- Participant has signs and symptoms of increased intracranial pressure or symptomatic mass effect, midline shift or evidence of subfalcine, uncal or...
- Participant receiving Bevacizumab (Avastin) therapy, or other drugs with a proclivity for causing bleeding.
- History of bleeding disorders or tissue pathologies which increase the subject's risk of hemorrhage for anticoagulation medications, implement...
- Participant has an infectious viral infection such as active Hepatitis B, Hepatitis C or detectable HIV viral load or participants with active...
See the full eligibility criteria
- Participant is ≥ 18 years of age
- The participant provides written informed consent for the trial
- Participant is willing to comply with all study procedures for the duration of the study
- Participant has a Karnofsky Performance Status ≥ 70% and/or ECOG 0-2
- Participant is a NSCLC subject prescribed immune checkpoint inhibitor systemic therapy according to on-label use with the target brain lesion(s) measuring ≥ 0.5 cm in longest diameter. Target mets may include: De novo...
- Female subject is not planning pregnancy during the study duration and confirmed NOT PREGNANT each procedure day.
- Screening/Baseline laboratory values Screening/Baseline should adhere to local standard of care lab values for ICI therapy
- Participant has evidence of acute intracranial hemorrhage
- Participant at risk for spontaneous intracranial hemorrhage (e.g., history of metastatic melanoma or other tissue histology).
- Participant has signs and symptoms of increased intracranial pressure or symptomatic mass effect, midline shift or evidence of subfalcine, uncal or tonsillar herniation.
- Participant receiving Bevacizumab (Avastin) therapy, or other drugs with a proclivity for causing bleeding.
- History of bleeding disorders or tissue pathologies which increase the subject's risk of hemorrhage for anticoagulation medications, implement pre-surgical standard procedure to avoid increased risk of a bleeding event.
- Participant has an infectious viral infection such as active Hepatitis B, Hepatitis C or detectable HIV viral load or participants with active bacterial infection such as TB (Bacillus tuberculosis) that may, in the...
- people with evidence of cranial or systemic infection.
- Participant has received a solid organ or hematopoietic stem cell transplant.
- Participant has received a live vaccine within 28 days prior to the first on-study ICI infusion with or without Exablate.
- Known sensitivity to DEFINITY® ultrasound contrast agent or hypersensitivity to perflutren microsphere or its components, e.g., polyethylene glycol, as found in MiraLAX and bowel prep products.
- Contraindications to MRI and gadolinium-DTPA including non-MRI-compatible implanted devices, severe claustrophobia, unable to lie supine in MRI.
- people with significant liver dysfunction, (cirrhosis, hemochromatosis, severe alcohol abuse, or active hepatitis (autoimmune or infectious))
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the...
- Has a known additional malignancy that requires active treatment that would interfere with study procedures.
- Known presence of leptomeningeal disease.
- Has a diagnosis of active autoimmune disease (e.g., autoimmune Hepatitis, Guillain-Barre Syndrome, etc.) requiring systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or...
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is...
- Subject is currently enrolled in another intervention based clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Newport Beach, California, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Baltimore, Maryland, United States
- Winston-Salem, North Carolina, United States
- Portland, Oregon, United States
- Providence, Rhode Island, United States
- Richmond, Virginia, United States
- Toronto, Ontario, Canada
- Seoul, Seoul, South Korea
- Seoul, South Korea
- Soeul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Newport Beach, California, United States; Miami, Florida, United States; Tampa, Florida, United States; Baltimore, Maryland, United States; Winston-Salem, North Carolina, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.