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Focused Ultrasound + PD-1 Blockade for Advanced Cancers (AM-003 Trial)
Charlottesville, VA
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 43 (cohort 1) or day 36 (cohort 2)
Awards & highlights
No Placebo-Only Group
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.
See full description
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 43 (cohort 1) or day 36 (cohort 2)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 43 (cohort 1) or day 36 (cohort 2)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
To estimate the proportion of patients with increased CD8+ T cell infiltration, after spot FUSA, in untreated metastasis, when available.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~280
Find a Location
Closest Location:University of Virginia· Charlottesville, VA· 277 miles
Who is running the clinical trial?
Craig L Slingluff, JrLead Sponsor
23 Previous Clinical Trials
741 Total Patients Enrolled
TheraclionIndustry Sponsor
21 Previous Clinical Trials
729 Total Patients Enrolled
Lynn Dengel, MD, MScPrincipal InvestigatorUniversity of Virginia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tried other treatments that didn't work, or you can't use standard treatments because they are not safe for you.You are 18 years old or older.You have a type of cancer that has spread and can be measured.You have tried standard treatments and they didn't work, or you can't use them because of other health reasons.You have advanced solid tumors with skin, tissue, or lymph node spread that can be reached for ultrasound and biopsy.You have HIV, or currently have Hepatitis B or C, unless there are some special circumstances.You have an ongoing infection that needs treatment with medication throughout your body.You have severe heart disease categorized as Class III or IV by the New York Heart Association.You have a history of autoimmune disorders that needed strong medication to treat, or your autoimmune disorder affected your internal organs.You have had another type of cancer in the past, with some exceptions.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.You are able to perform daily activities without any major issues.You have received a specific treatment called polyICLC within the past 4 weeks, unless there are special circumstances.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.If you have cancer that has gotten worse while on a specific type of treatment, but your doctor thinks it's best for you to continue with that treatment, then you may still be able to join this study. This could apply if you have some new small areas of cancer growth, or if your cancer has only slightly grown in multiple areas and there are no other treatment options available for you. If you have cancer that has gotten worse after a certain type of treatment, you may still be able to join this study if you have some areas of cancer that can't be removed and can be treated with a specific type of therapy.The area we want to study must be visible and meet certain requirements when seen using ultrasound.You have a type of cancer that has spread and can be measured.You are 18 years old or older.If your condition has not worsened after 12 weeks of treatment with PD1/PDL1 therapy, you may still be eligible for this trial. Your doctor may recommend continuing PD1/PDL1 therapy even if you are not on this trial.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2, primary regimen (Regimen 1b)
- Group 2: Cohort 1, primary regimen (Regimen 1a)
- Group 3: Cohort 1, secondary regimen (Regimen 2a)
- Group 4: Cohort 2, secondary regimen (Regimen 2b)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Cervical Cancer Patient Testimony for trial: Trial Name: NCT04116320 — Phase 1