Actively Recruiting
FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma
Led by University of Virginia · Updated on 2025-11-20
11
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
Sponsors
U
University of Virginia
Lead Sponsor
T
Theraclion
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with advanced melanoma planned for surgical removal
- Tumors visible by ultrasound and suitable for focused ultrasound treatment
- Tumor target area between 5 mm and 23 mm from skin surface and safely away from critical structures
- Target tumor amenable to injection with polyICLC
- Receiving checkpoint blockade immunotherapy at time of registration
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Participants with brain metastases may join if no recent growth, no lesions larger than 2 cm, symptoms returned to baseline, no new or enlarging metastases, and off steroids for at least 7 days
You will not qualify if you...
- Radiation therapy, allergy desensitization injections, high doses of systemic corticosteroids, growth factors, interleukins, investigational agents, targeted BRAF or MEK therapies, live vaccines, interferon, or cytotoxic chemotherapy within 4 weeks before study day 1
- Known addiction to alcohol or drugs with recent or ongoing use
- HIV positive without stable antiretroviral therapy or active Hepatitis B or C with detectable viral load
- Pregnant or breastfeeding; females must have negative pregnancy test and agree to birth control
- Medical conditions preventing protocol compliance
- Active infection needing systemic treatment
- Severe heart disease (Class III or IV NYHA)
- Previous polyICLC treatment within 4 weeks or significant toxicity from prior polyICLC treatment on same tumor
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
O
Olena Glushakova
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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