Focused Ultrasound + Immunotherapy for Brain Cancer
(LIMITLESS Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on Bevacizumab (Avastin) or certain immunosuppressive therapies, you may not be eligible to participate.
What data supports the effectiveness of the treatment Focused Ultrasound + Immunotherapy for Brain Cancer?
Pembrolizumab, a part of the treatment, has shown effectiveness in treating various cancers, including melanoma and lung cancer, by helping the immune system attack cancer cells. In studies, it has demonstrated significant tumor response rates and prolonged response durations, suggesting potential benefits in treating brain cancer as well.12345
Is the combination of focused ultrasound and pembrolizumab (Keytruda) generally safe for humans?
Pembrolizumab (Keytruda) has been approved for use in various cancers and is generally considered safe, but it can cause side effects like fatigue, cough, and nausea, and more serious immune-related issues like pneumonitis (lung inflammation) and thyroid problems. While focused ultrasound safety data isn't provided here, pembrolizumab's safety profile is well-documented in cancer treatments.14678
What makes the treatment of focused ultrasound combined with pembrolizumab unique for brain cancer?
This treatment is unique because it combines focused ultrasound, a non-invasive technique that uses sound waves to target tumors, with pembrolizumab, an immunotherapy drug that helps the immune system attack cancer cells by blocking a protein called PD-1. This combination aims to enhance the effectiveness of the immune response against brain cancer, which is different from traditional treatments that may not involve the immune system.1491011
Research Team
Manmeet Ahluwalia, MD, MBA
Principal Investigator
Miami Cancer Institute, Baptist Health South Florida
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ICI Systemic Therapy with Exablate BBBO or ICI Systemic Therapy alone every 3 weeks for 6 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of tumor response and adverse events
Treatment Details
Interventions
- Exablate Model 4000 Type 2.0/2.1
- Pembrolizumab
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
InSightec
Lead Sponsor
Dr. Maurice R. Ferré
InSightec
Chief Executive Officer
MD
Dr. Arjun Desai
InSightec
Chief Medical Officer
MD