Study of Focused Ultrasound Ablation and Intratumoral PolyICLC Injection for Adults with Advanced Melanoma Undergoing Surgery and Immunotherapy

What this Trial Is About

This research aims to evaluate the safety of an experimental treatment for adult patients with advanced melanoma who are receiving immunotherapy and planning to have surgery for their cancer. The study focuses on a combination of focused ultrasound ablation FUSA, a non-invasive method that uses ultrasound waves to heat and destroy tumor tissue, and an injection of the experimental immune-activating drug polyICLC directly into the tumor. Neither the drug nor the device used in this study are currently approved by the U.S. Food and Drug Administration. Participants will receive the experimental treatment approximately three weeks before their planned melanoma surgery. The FUSA treatment is delivered using one of two investigational devices Echopulse or Echopulse HD while the participant is sedated. Up to two tumors may be treated with FUSA during the session. Following FUSA, a single injection of polyICLC will be administered into one tumor within four hours. The study also includes tumor elastography imaging to measure tumor stiffness and optional tumor biopsies and blood collection for research purposes. Throughout the study, participants will be monitored for adverse events from day 1 through day 22 and have their tumor tissue evaluated for the extent of ablation and surrounding tumor effects on day 22. Researchers will collect imaging, biopsy samples, and other data to understand how the treatment affects tumor cells. The total study duration includes the treatment period before surgery and follow-up assessments to evaluate safety and treatment effects.

FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma