FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

September 30, 2024

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
Advanced Melanoma
Interventions
DEVICE

Echopulse or Echopulse HD

The Echopulse/Echopulse HD device delivers focused ultrasound ablation (FUSA) therapy. FUSA is a technology that delivers continuous high-intensity focused ultrasound to ablate (heat and destroy) tissue. A series of sound waves will be focused on the tumor using the Echopulse or the Echopulse HD device to cover the planned target area. The targeted area is 33% of the tumor, up to 3.5 cubic centimeters. An ultrasound will be used to guide the beam of the FUSA treatment to the targeted site. FUSA will be applied to up to two tumors in the session. Participants are sedated during the FUSA treatment.

DRUG

PolyICLC

PolyICLC (polyinosinic-polycytidylic acid that is stabilized with carboxymethylcellulose and polylysine) is a drug that may help the body build an effective immune response to kill tumor cells. A single injection of .9 mg of polyICLC into one tumor will be given within 4 hours after the FUSA.

Trial Locations (1)

22908

RECRUITING

University of Virginia, Charlottesville

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Theraclion

INDUSTRY

lead

University of Virginia

OTHER