FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma (NCT06472661)

🧪 Interventions in This Study

• Echopulse or Echopulse HD (DEVICE)
• PolyICLC (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.
4. Approximately 1 cm (or more) diameter of treatable tumor volume for lesions to be treated with FUSA.
5. 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.
6. 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.
7. The anterior-posterior dimension of the treatment area by US should be no less than 9 mm.
8. A subjects target lesion must be amenable to intratumoral injection with polyICLC per the treating clinician's discretion.
9. Subjects must be receiving checkpoint blockade (either monotherapy or combination therapy) at the time of registration.
10. Biopsies: Note: Biopsies may be completed with or without image guidance. Lesions that have been selected for focused ultrasound may have been previously radiated provided:
11. The tumor site that was previously radiated has progressed.
12. A baseline biopsy of the tumor site is obtained following progression and prior to study entry.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• University of Virginia — Charlottesville, Virginia

📞 Contact the Study Coordinator

Phone: (434) 243-0452

Email: OYG2N@uvahealth.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Advanced Melanoma

• Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors — St Louis, Missouri
• Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM) — Phoenix, Arizona
• Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial — Fairhope, Alabama
• Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery — Birmingham, Alabama
• Naltrexone and Propranolol Combined With Immunotherapy — New Brunswick, New Jersey

Explore by condition: All Advanced Melanoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.