FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma

NCT06472661 | Recruiting Early Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: HSR230477
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Advanced Melanoma

Keywords

Melanoma; Advanced Melanoma; Focused Ultrasound; polyICLC; poly ICLC; poly-ICLC; Echopulse; Echopulse HD; Focused Ultrasound Ablation

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  Incidence and severity of adverse events (Common Terminology Criteria for Adverse Events \[CTCAE\] v5).

  Collected from Day 1 up to Day 22

• Pathologic ablation zone

  Proportion of patients where the size of the pathologic ablation zone is within 20% of the planned zone

  Day 22

Secondary Outcomes (1)

• Presence of Periablation Zone

  Day 22

Study Arms (1)

FUSA + polyICLC

EXPERIMENTAL

Focused Ultrasound Ablation plus intratumoral injection of polyICLC

Device: Echopulse or Echopulse HD; Drug: PolyICLC

Interventions

Echopulse or Echopulse HD DEVICE

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.

Also known as: Focused Ultrasound Ablation, FUSA

FUSA + polyICLC

PolyICLC DRUG

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.

Also known as: Hiltinol

FUSA + polyICLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Diagnosis of advanced melanoma planned for surgical resection.
• 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.
• Approximately 1 cm (or more) diameter of treatable tumor volume for lesions to be treated with FUSA.
• 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.
• 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.
• The anterior-posterior dimension of the treatment area by US should be no less than 9 mm.
• A subjects target lesion must be amenable to intratumoral injection with polyICLC per the treating clinician's discretion.
• Subjects must be receiving checkpoint blockade (either monotherapy or combination therapy) at the time of registration.
• 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:
• The tumor site that was previously radiated has progressed.

You may not qualify if:

• Any of the following medications or treatments are administered to the subject within 4 weeks of study day 1:
• Radiation therapy (Note: Stereotactic radiotherapy, such as gamma knife, can be used ≥ 1 week prior to registration)
• Allergy desensitization injections
• High doses of systemic corticosteroids, with the following qualifications and exceptions:
• Daily doses of 10 mg or less prednisone (or equivalent) per day administered parenterally or orally are allowed in patients with normal adrenal and pituitary function.
• In patients with adrenal or pituitary insufficiency replacement steroid doses are allowed.
• Inhaled steroids (e.g.: Advair®, Flovent®, Azmacort®) are permitted at low doses (less than 500 mcg fluticasone per day, or equivalent) 41,42
• Topical and nasal corticosteroids are acceptable.
• Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)
• Interleukins (e.g. Proleukin®)
• Any investigational therapeutic agent.
• Targeted therapies specific for mutated BRAF or for MEK
• Live vaccine
• Interferon (e.g. Intron-A®)
• Cytotoxic chemotherapy for cancer

Sponsors & Collaborators

• University of Virginia: lead
• Theraclion: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

High-Intensity Focused Ultrasound Ablation

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Lynn T Dengel, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olena Glushakova

CONTACT

434-243-0452; OYG2N@uvahealth.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 25, 2024
• Study Start: September 27, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)