About this trial
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 criteria
Qualifiers
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.
Approximately 1 cm (or more) diameter of treatable tumor volume for lesions to be treated with FUSA.
Disqualifiers
Radiation therapy (Note: Stereotactic radiotherapy, such as gamma knife, can be used ≥ 1 week prior to registration)
Allergy desensitization injections
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.
Trial design
Treatments tested in this trial
- Echopulse or Echopulse HD
- PolyICLC
Treatment groups
Sponsors and collaborators
University of Virginia
Lead sponsor
Theraclion
Collaborator