FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT06472661
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Advanced Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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).

Key Dates

Start date
Sep 27, 2024
Status verified
Nov 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
11 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FUSA + polyICLC
    Focused Ultrasound Ablation plus intratumoral injection of polyICLC

Primary Outcome Measure

Adverse Events [ Time Frame: Collected from Day 1 up to Day 22 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22908
Olena Glushakova
[email protected]
4342430452

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By research site
University of Virginia· Charlottesville, VA

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