FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma
This study tests a new treatment approach for advanced melanoma that combines focused ultrasound (a non-invasive technique using sound waves) with an immune-boosting injection directly into the tumor, for patients who are already receiving immunotherapy and planning surgery. The goal is to see if this combination helps improve treatment outcomes before surgical removal of the cancer.
Key Objective:This trial is testing whether combining focused ultrasound with an immune-stimulating injection can enhance the body's immune response to melanoma and improve surgical outcomes.
Who to Consider:Adults with regionally advanced melanoma who are currently receiving immunotherapy and have plans to undergo surgery should consider enrolling.
Trial Parameters
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Brief Summary
This study is for adult patients with advanced melanoma who are receiving immunotherapy and who are planning on having surgery for their cancer. All participants in this study will receive an experimental treatment made up of focused ultrasound ablation (FUSA), a non-invasive experimental treatment that uses ultrasound waves to heat and destroy tumor tissue, and an injection in the tumor with an experimental drug that activates the immune system called polyICLC (polyinosinic-polycytidylic acid that is stabilized with carboxymethylcellulose and polylysine). Neither the drug nor the device that are used in this study have been approved by the U.S. Food and Drug Administration (FDA).
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years. 2. Diagnosis of advanced melanoma planned for surgical resection. 3. Focused Ultrasound Ablation (FUSA): The targeted lesion(s) must be visible by ultrasound imaging and meet the following criteria. Note: Brain lesions may not be targeted for treatment. 1. Approximately 1 cm (or more) diameter of treatable tumor volume for lesions to be treated with FUSA. 2. The target treatment area needs to be contained within a region at least 5 mm from the skin surface and less than or equal to 23 mm from the skin surface. The target treatment area must be at a safe distance from all critical structures, including but not limited to ribs or other bony structures, vital organs, named blood vessels or nerves. 3. The critical structures, with the exception of the skin, will not be in the pre-focal ultrasound path. This will be considered at enrollment and confirmed immediately prior to treatment. 4. The anterior-posterior dimension of the treatment area by US shou