Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors

Summary

This study evaluates whether it is safe to Focused Ultrasound Ablation (FUSA) treatments with and without PD-1 blockade and with and without intratumoral poly-ICLC. A device called the Echopulse will be used for the FUSA therapy. Patients will be assigned to 1 of 2 cohorts depending on their disease and treatment status. In Cohort 1, patients will receive FUSA therapy while receiving PD-1 blockade therapy as part of standard clinical care treatment. In Cohort 2, patients who discontinue or are ineligible for PD-1 blockade therapy will undergo FUSA without concurrent systemic therapy, with the goal of utilizing the FUSA to boost the innate immune response. The optional secondary regimen will combine FUSA (+/- PD-1 blockade) with intratumoral poly-ICLC.

Conditions

• Melanoma
• Breast Cancer
• Merkel Cell Carcinoma
• Squamous Cell Cancer
• Non Small Cell Lung Cancer
• Cervical Cancer
• Urothelial Carcinoma
• Ovarian Cancer
• Hepatocellular Carcinoma
• Small-cell Lung Cancer
• Microsatellite Instability High
• Gastric Cancer
• Esophageal Cancer

Interventions

DEVICE

Echopulse

The Echopulse device delivers focused ultrasound ablation (FUSA) therapy. FUSA is a technology that delivers continuous high-intensity focused ultrasound to ablate tissue.

DRUG

Poly ICLC

Poly-ICLC is a TLR3 agonist.

DRUG

Standard of Care PD-1 Therapy

PD-1 therapy FDA approved for use on a 3-week schedule will be used per standard of care.

Sponsors & Collaborators

• Theraclion

  collaborator INDUSTRY

• Craig L Slingluff, Jr

  lead OTHER

Principal Investigators

• Lynn Dengel, MD, MSc · University of Virginia

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-21

Primary Completion

2023-08-15

Completion

2023-08-15

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations