Trials / Terminated

TerminatedNCT04116320

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

Pilot Evaluation of Focused Ultrasound Ablation and Focused Ultrasound Ablation Plus PD-1 Antibody Blockade in Advanced Solid Tumors

Status: Terminated
Phase: Phase 1
Study type: Interventional
Enrollment: 5 (actual)

Sponsor: Craig L Slingluff, Jr · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

Start date: 2019-11-21
Primary completion: 2023-08-15
Completion: 2023-08-15
First posted: 2019-10-04
Last updated: 2025-07-14

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study
FDA-regulated device study

Source: ClinicalTrials.gov record NCT04116320. Inclusion in this directory is not an endorsement.