NCT06472661

FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma

Pilot Evaluation of Focused Ultrasound Ablation and Intratumoral PolyICLC in Patients With Regionally Advanced Resectable Melanoma Who Are Receiving Neoadjuvant Immunotherapy

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 11 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study is for patients with advanced melanoma who are receiving immunotherapy and who are planning to have surgery for their melanoma cancer. The purpose of this study is to try to figure out the safety of an experimental treatment for melanoma. The experimental treatment is made up of focused ultrasound ablation (FUSA) and an injection in the tumor (intratumoral injection) with an experimental drug called polyICLC (polyinosinic-polycytidylic acid that is stabilized with carboxymethylcellulose and polylysine), also known as Hiltinol, that activates the immune system. The researchers also want to use the results from this clinical trial to help understand how the FUSA and polyICLC affect the tumor cells at the place where the FUSA is given and how much of the surrounding tumor is affected. The experimental treatment in this study is given at the University of Virginia Medical Center about three weeks before the melanoma tumor surgery that would occur as part of the participant's regular care. FUSA is a non-invasive experimental treatment that uses ultrasound waves to heat and destroy tumor tissue. FUSA is administered using an investigational device. There are two models of the investigational device (Echopulse® or the Echopulse HD®) that will be used in the study to deliver the FUSA. Both devices provide the same type of investigational treatment. Participants are sedated during the FUSA procedure. Up to two tumors will be treated with FUSA. The polyICLC drug will be given as a one-time injection into one tumor only after the FUSA treatment. Neither the drug nor the device that are used in this study have been proven to be safe or helpful, and they are not approved by the U.S. Food and Drug Administration (FDA). This study also includes tumor elastography procedures. Tumor elastography is an ultrasound picture that is taken to measure the stiffness or the flexibility of the tumor. Participants in the study may be asked to have a biopsy of their tumor before starting the study intervention and will be asked participate in optional biopsies of the tumor after enrollment in the study. This study includes collection of blood for research purposes (optional).

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
DEVICE	Echopulse or Echopulse HD	The Echopulse/Echopulse HD device delivers focused ultrasound ablation (FUSA) therapy. FUSA is a technology that delivers continuous high-intensity focused ultrasound to ablate (heat and destroy) tissue. A series of sound waves will be focused on the tumor using the Echopulse or the Echopulse HD device to cover the planned target area. The targeted area is 33% of the tumor, up to 3.5 cubic centimeters. An ultrasound will be used to guide the beam of the FUSA treatment to the targeted site. FUSA will be applied to up to two tumors in the session. Participants are sedated during the FUSA treatment.
DRUG	PolyICLC	PolyICLC (polyinosinic-polycytidylic acid that is stabilized with carboxymethylcellulose and polylysine) is a drug that may help the body build an effective immune response to kill tumor cells. A single injection of .9 mg of polyICLC into one tumor will be given within 4 hours after the FUSA.

Timeline

• Start date: 2024-09-27
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2024-06-25
• Last updated: 2025-11-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study