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Focused Ultrasound + PD-1 Blockade for Advanced Cancers (AM-003 Trial)

Phase 1
Waitlist Available
Led By Lynn Dengel, MD, MSc
Research Sponsored by Craig L Slingluff, Jr
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Advanced solid tumor with measurable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 43 (cohort 1) or day 36 (cohort 2)
Awards & highlights

AM-003 Trial Summary

This trial is testing whether Focused Ultrasound Ablation (FUSA) is safe to use with and without PD-1 blockade and with and without intratumoral poly-ICLC.

Who is the study for?
Adults with advanced solid tumors who have not responded to standard treatments or cannot receive them. They should have measurable disease and accessible tumor deposits for Focused Ultrasound Ablation (FUSA). Patients already on PD-1 therapy may qualify, but those with certain heart diseases, active infections, or a history of other cancers might be excluded.Check my eligibility
What is being tested?
The trial is testing the safety of combining Focused Ultrasound Ablation (using Echopulse) with PD-1 blockade therapy (standard cancer care), and optionally poly-ICLC. Participants are divided into two groups: one receiving both therapies and another undergoing FUSA alone if they can't have PD-1 therapy.See study design
What are the potential side effects?
Potential side effects include typical reactions to immunotherapy like fatigue, skin reactions, inflammation in organs, as well as specific issues related to ultrasound treatment such as discomfort at the treatment site.

AM-003 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are 18 years old or older.
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You have a type of cancer that has spread and can be measured.
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You have tried standard treatments and they didn't work, or you can't use them because of other health reasons.
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For the first group of patients, you have an advanced solid cancer that can be treated with a specific type of medication and have tumors that can be treated with focused ultrasound. If you have uveal melanoma, you cannot participate in this group.
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For Cohort 2, if you have tried all the approved treatments that are known to work for your condition and they didn't help or you couldn't tolerate them, then you can participate in the primary treatment for Cohort 2.
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You are able to perform daily activities without any major issues.
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You have advanced solid tumors with skin, tissue, or lymph node spread that can be reached for ultrasound and biopsy.
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The area we want to study must be visible and meet certain requirements when seen using ultrasound.

AM-003 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 43 (cohort 1) or day 36 (cohort 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 43 (cohort 1) or day 36 (cohort 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To assess the safety and toxicity of FUSA administered alone or in combination with PD-1 antibody blockade.
To estimate the proportion of patients with increased CD8+ T cell infiltration of spot FUSA-treated metastasis.
Secondary outcome measures
To estimate the proportion of patients with increased CD8+ T cell infiltration, after spot FUSA, in untreated metastasis, when available.

AM-003 Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 2, secondary regimen (Regimen 2b)Experimental Treatment2 Interventions
FUSA therapy and intratumoral poly-ICLC will be administered on day 1.
Group II: Cohort 2, primary regimen (Regimen 1b)Experimental Treatment2 Interventions
FUSA therapy will be administered on day 1.
Group III: Cohort 1, secondary regimen (Regimen 2a)Experimental Treatment3 Interventions
FUSA therapy, standard of care PD-1 blockade, and intratumoral poly-ICLC will be administered on day 8.
Group IV: Cohort 1, primary regimen (Regimen 1a)Experimental Treatment2 Interventions
FUSA therapy and standard of care PD-1 blockade. FUSA therapy will be administered on day 8.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Echopulse
2015
N/A
~530
Poly ICLC
2014
Completed Phase 2
~270

Find a Location

Who is running the clinical trial?

Craig L Slingluff, JrLead Sponsor
23 Previous Clinical Trials
741 Total Patients Enrolled
TheraclionIndustry Sponsor
20 Previous Clinical Trials
718 Total Patients Enrolled
Lynn Dengel, MD, MScPrincipal InvestigatorUniversity of Virginia

Media Library

Echopulse (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04116320 — Phase 1
Microsatellite Instability Research Study Groups: Cohort 1, primary regimen (Regimen 1a), Cohort 1, secondary regimen (Regimen 2a), Cohort 2, primary regimen (Regimen 1b), Cohort 2, secondary regimen (Regimen 2b)
Microsatellite Instability Clinical Trial 2023: Echopulse Highlights & Side Effects. Trial Name: NCT04116320 — Phase 1
Echopulse (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04116320 — Phase 1
Microsatellite Instability Patient Testimony for trial: Trial Name: NCT04116320 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings still available for this clinical experimentation?

"Affirmative. According to clinicaltrials.gov, this research endeavour was initially posted on November 21st 2019 and most recently revised on June 23rd 2022. The study is currently in search of 32 participants from a single site."

Answered by AI

What potential risks do patients face when using Echopulse?

"The safety of Echopulse has been assessed as a 1, due to the minimal clinical data demonstrating its efficacy and security in this Phase One trial."

Answered by AI

What maladies does Echopulse typically address?

"Echopulse is often used to address scalp structure issues, but it can also be utilized to treat condylomata acuminata, facial features and superficial basal cell carcinoma."

Answered by AI

What is the current number of participants in this research project?

"Affirmative, the information located on ClinicalTrials.gov points to this trial actively seeking participants since first posted in November 2019 and last updated June 2022; with an aim of enrolling 32 individuals from one site."

Answered by AI

Is there previous research that has utilized Echopulse technology?

"Currently, 21 trials are being conducted on Echopulse, 5 of which are in the third and final stage. Most locations for such studies can be found in Houston, Texas; however, 84 sites worldwide have been approved to run these experiments."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
University of Virginia
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Stage 4 lung cancer. It has to metastasize to the brain.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long do screening visit takes?
PatientReceived 2+ prior treatments
~1 spots leftby Mar 2025