RecruitingEarly Phase 1NCT06472661

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


Sponsor

University of Virginia

Enrollment

11 participants

Start Date

Sep 27, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment for advanced melanoma (a serious type of skin cancer). It uses focused ultrasound (sound waves) to destroy tumor tissue, followed by an injection of a drug (polyICLC) directly into the tumor to activate the immune system. The goal is to see if this combination, alongside the immune checkpoint therapy you are already receiving, can shrink tumors more effectively. **You may be eligible if...** - You are 18 or older with advanced melanoma planned for surgery - The tumor can be seen on ultrasound and is accessible for treatment - You are already receiving immunotherapy (checkpoint blockade therapy) - You are generally able to carry out daily activities **You may NOT be eligible if...** - You received radiation therapy, certain immune-suppressing drugs, or chemotherapy within the past 4 weeks - You have active, serious infections - You have severe heart disease (Class III or IV) - You have HIV or active Hepatitis B or C (unless on stable treatment with undetectable levels) - You are pregnant or breastfeeding - You have a known alcohol or drug addiction and are actively using Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEchopulse 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.

DRUGPolyICLC

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.


Locations(1)

University of Virginia

Charlottesville, Virginia, United States

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NCT06472661


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