drugset / Trial / NCT06472661

FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma

NCT06472661

Phase 0 Recruiting 11 enrolled University of Virginia Theraclion · collab
NaSingle-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2024-09-27
Primary completion
2026-08
Completion
2026-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Hiltonol Other / unclassified 0.9 mg Intrathecal

Indications