OncoMatch/Clinical Trials/NCT06472661
FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma
Is NCT06472661 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including Echopulse or Echopulse HD and PolyICLC for advanced melanoma.
Treatment: Echopulse or Echopulse HD · PolyICLC — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: checkpoint inhibitor — current
Subjects must be receiving checkpoint blockade (either monotherapy or combination therapy) at the time of registration.
Cannot have received: radiation therapy
Exception: Stereotactic radiotherapy (e.g., gamma knife) can be used ≥ 1 week prior to registration
Radiation therapy (Note: Stereotactic radiotherapy, such as gamma knife, can be used ≥ 1 week prior to registration)
Cannot have received: allergy desensitization injections
Allergy desensitization injections
Cannot have received: systemic corticosteroids (high dose)
Exception: Daily doses of 10 mg or less prednisone (or equivalent) per day allowed in patients with normal adrenal and pituitary function; replacement steroid doses allowed in adrenal/pituitary insufficiency; inhaled steroids <500 mcg fluticasone/day allowed; topical and nasal corticosteroids acceptable.
High doses of systemic corticosteroids, with the following qualifications and exceptions: ... (see text for details)
Cannot have received: growth factors (Procrit, Aranesp, Neulasta)
Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)
Cannot have received: interleukins (Proleukin)
Interleukins (e.g. Proleukin®)
Cannot have received: investigational therapeutic agent
Any investigational therapeutic agent
Cannot have received: BRAF inhibitor
Targeted therapies specific for mutated BRAF
Cannot have received: MEK inhibitor
Targeted therapies specific for ... MEK
Cannot have received: live vaccine
Live vaccine
Cannot have received: interferon (Intron-A)
Interferon (e.g. Intron-A®)
Cannot have received: cytotoxic chemotherapy
Cytotoxic chemotherapy for cancer
Cannot have received: polyICLC
Exception: Previous treatment with polyICLC within 4 weeks. If previously treated with intratumoral polyICLC and experienced grade ≥3 toxicity, the tumor that was treated should not be re-treated.
Previous treatment with polyICLC within 4 weeks. If a subject was previously treated with intratumoral polyICLC and experienced a significant (grade ≥3) toxicity related to the polyICLC treatment, the tumor that was treated should not be re-treated as part of this protocol.
Lab requirements
Cardiac function
No Class III or IV heart disease as classified according to the New York Heart Association.
The presence of Class III or IV heart disease as classified according to the New York Heart Association.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Virginia · Charlottesville, Virginia
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