Advanced MelanomaEarly Phase 1Mel 70NCT06472661
FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma
A Early Phase 1 study testing Echopulse or Echopulse HD and PolyICLC in people with Advanced Melanoma, run by University of Virginia at 1 site in United States.
Trial summary
This study is for adult patients with advanced melanoma who are receiving immunotherapy and who are planning on having surgery for their cancer. All participants in this study will receive an experimental treatment made up of focused ultrasound ablation (FUSA), a non-invasive experimental treatment that uses… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Melanoma
- What is being tested?
- Echopulse or Echopulse HD and PolyICLC
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2024to Aug 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Diagnosis of advanced melanoma planned for surgical resection.
- Focused Ultrasound Ablation (FUSA): The targeted lesion(s) must be visible by ultrasound imaging and meet the following criteria.
- Note: Brain lesions may not be targeted for treatment.
- Approximately 1 cm (or more) diameter of treatable tumor volume for lesions to be treated with FUSA.
- The target treatment area needs to be contained within a region at least 5 mm from the skin surface and less than or equal to 23 mm from the skin surface.
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- The target treatment area must be at a safe distance from all critical structures, including but not limited to ribs or other bony structures, vital organs, named blood vessels or nerves.
- The critical structures, with the exception of the skin, will not be in the pre-focal ultrasound path. This will be considered at enrollment and confirmed immediately prior to treatment.
- The anterior-posterior dimension of the treatment area by US should be no less than 9 mm.
- A subjects target lesion must be amenable to intratumoral injection with polyICLC per the treating clinician's discretion.
- Subjects must be receiving checkpoint blockade (either monotherapy or combination therapy) at the time of registration.
- Biopsies:
- Note: Biopsies may be completed with or without image guidance.
- Lesions that have been selected for focused ultrasound may have been previously radiated provided:
- The tumor site that was previously radiated has progressed.
- A baseline biopsy of the tumor site is obtained following progression and prior to study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Subjects with known brain metastases may participate if all of the following are true:
- There has been no evident growth of any brain metastasis since the most recent treatment
- No brain metastasis is > 2 cm in diameter at the time of registration.
- Neurologic symptoms have returned to baseline,
- There is no evidence of new or enlarging brain metastases,
- Subjects are not using steroids for at least 7 days prior to registration, except as allowed in Section 5.2. Regardless of dose, however, subjects who are on a steroid taper for management of brain metastases are not eligible until 7 days after completion of that steroid taper.
- Ability and willingness to give informed consent.
Who cannot join
- Any of the following medications or treatments are administered to the subject within 4 weeks of study day 1:
- Radiation therapy (Note: Stereotactic radiotherapy, such as gamma knife, can be used ≥ 1 week prior to registration)
- Allergy desensitization injections
- High doses of systemic corticosteroids, with the following qualifications and exceptions:
- Daily doses of 10 mg or less prednisone (or equivalent) per day administered parenterally or orally are allowed in patients with normal adrenal and pituitary function.
- In patients with adrenal or pituitary insufficiency replacement steroid doses are allowed.
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- Inhaled steroids (e.g.: Advair®, Flovent®, Azmacort®) are permitted at low doses (less than 500 mcg fluticasone per day, or equivalent) 41,42
- Topical and nasal corticosteroids are acceptable.
- Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)
- Interleukins (e.g. Proleukin®)
- Any investigational therapeutic agent.
- Targeted therapies specific for mutated BRAF or for MEK
- Live vaccine
- Interferon (e.g. Intron-A®)
- Cytotoxic chemotherapy for cancer
- Subject has a known addiction to alcohol or drugs and is actively taking those agents, or has recently (within 1 year) taken these agents or has ongoing illicit IV drug use.
- Subject is known to be HIV positive or has evidence of active Hepatitis B or C virus, unless:
- The subject has HIV but has been taking antiretroviral therapy, and agrees to take antiretroviral therapy throughout the study
- The subject has active Hepatitis B or C but does not have a detectable viral load
- Pregnancy or breastfeeding. Female participants of childbearing potential must have a negative pregnancy test (urinary or serum beta-HCG) obtained within 2 weeks prior to registration. Males and females must agree, in the consent form, to use effective birth control methods during the course of treatment and following treatment in accordance with the labeling guidelines for each approved therapy.
- Medical contraindications or potential problems that prevent compliance with the requirements of the protocol in the opinion of the investigator.
- Active infection requiring systemic therapy.
- The presence of Class III or IV heart disease as classified according to the New York Heart Association.
- Previous treatment with polyICLC within 4 weeks. If a subject was previously treated with intratumoral polyICLC and experienced a significant (grade ≥3) toxicity related to the polyICLC treatment, the tumor that was treated should not be re-treated as part of this protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Olena Glushakova, 4342430452, OYG2N@uvahealth.org
About this study
Official title: Pilot Evaluation of Focused Ultrasound Ablation and Intratumoral PolyICLC in Patients With Regionally Advanced Resectable Melanoma Who Are Receiving Neoadjuvant Immunotherapy
This study is for adult patients with advanced melanoma who are receiving immunotherapy and who are planning on having surgery for their cancer. All participants in this study will receive an experimental treatment made up of focused ultrasound ablation (FUSA), a non-invasive experimental treatment that uses ultrasound waves to heat and destroy tumor tissue, and an injection in the tumor with an experimental drug that activates the immune system called polyICLC (polyinosinic-polycytidylic acid that is stabilized with carboxymethylcellulose and polylysine). Neither the drug nor the device that are used in this study have been approved by the U.S. Food and Drug Administration (FDA).
Read the detailed description
This study is for patients with advanced melanoma who are receiving immunotherapy and who are planning to have surgery for their melanoma cancer.
The purpose of this study is to try to figure out the safety of an experimental treatment for melanoma. The experimental treatment is made up of focused ultrasound ablation (FUSA) and an injection in the tumor (intratumoral injection) with an experimental drug called polyICLC (polyinosinic-polycytidylic acid that is stabilized with carboxymethylcellulose and polylysine), also known as Hiltinol, that activates the immune system. The researchers also want to use the results from this clinical trial to help understand how the FUSA and polyICLC affect the tumor cells at the place where the FUSA is given and how much of the surrounding tumor is affected. The experimental treatment in this study is given at the University of Virginia Medical Center about three weeks before the melanoma tumor surgery that would occur as part of the participant's regular care.
FUSA is a non-invasive experimental treatment that uses ultrasound waves to heat and destroy tumor tissue. FUSA is administered using an investigational device. There are two models of the investigational device (Echopulse® or the Echopulse HD®) that will be used in the study to deliver the FUSA. Both devices provide the same type of investigational treatment. Participants are sedated during the FUSA procedure. Up to two tumors will be treated with FUSA.
The polyICLC drug will be given as a one-time injection into one tumor only after the FUSA treatment.
Neither the drug nor the device that are used in this study have been proven to be safe or helpful, and they are not approved by the U.S. Food and Drug Administration (FDA).
This study also includes tumor elastography procedures. Tumor elastography is an ultrasound picture that is taken to measure the stiffness or the flexibility of the tumor. Participants in the study may be asked to have a biopsy of their tumor before starting the study intervention and will be asked participate in optional biopsies of the tumor after enrollment in the study. This study includes collection of blood for research purposes (optional).
- Conditions
- Advanced Melanoma
- Being tested
- Echopulse or Echopulse HD, PolyICLC
- Keywords
- Melanoma, Advanced Melanoma, Focused Ultrasound, polyICLC, poly ICLC, poly-ICLC, Echopulse, Echopulse HD, Focused Ultrasound Ablation
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echopulse or Echopulse HDDevice
Also called Focused Ultrasound Ablation, FUSA
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.
PolyICLCDrug
Also called Hiltinol
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.
| Study group | Role | What they receive |
|---|---|---|
| FUSA + polyICLC | Experimental | Focused Ultrasound Ablation plus intratumoral injection of polyICLC Receives: Device: Echopulse or Echopulse HD; Drug: PolyICLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Incidence and severity of adverse events (Common Terminology Criteria for Adverse Events [CTCAE] v5).
Measured: Collected from Day 1 up to Day 22
Pathologic ablation zone
Proportion of patients where the size of the pathologic ablation zone is within 20% of the planned zone
Measured: Day 22
Secondary outcomes (1)
Presence of Periablation Zone
Proportion of participants with a zone of tissue with live vasculature, fibrosis, and a histiocytic reaction as determined by hematoxylin and eosin (H\&E) staining and/or immunohistochemistry
Measured: Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start27 Sep 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MelanomaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Theraclion
- Responsible party
- Principal investigator, Lynn Dengel, MD, University of Virginia
- Investigators
- Lynn T Dengel, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472661
- Sponsor's protocol ID
- HSR230477
- Acronym
- Mel 70
- Status last verified
- Nov 2025
- First submitted
- 18 Jun 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of Focused Ultrasound Ablation and Intratumoral PolyICLC in Patients With Regionally Advanced Resectable Melanoma Who Are Receiving Neoadjuvant Immunotherapy
- ClinicalTrials.gov ID
- NCT06472661
- Acronym / sponsor ID
- Mel 70 / HSR230477
- Conditions
- Advanced Melanoma
- Keywords
- Melanoma, Advanced Melanoma, Focused Ultrasound, polyICLC, poly ICLC, poly-ICLC, Echopulse, Echopulse HD
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Theraclion
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for adult patients with advanced melanoma who are receiving immunotherapy and who are planning on having surgery for their cancer. All participants in this study will receive an experimental treatment made up of focused ultrasound ablation (FUSA), a non-invasive experimental treatment that uses ultrasound waves to heat and destroy tumor tissue, and an injection in the tumor with an experimental drug that activates the immune system called polyICLC (polyinosinic-polycytidylic acid that is stabilized with carboxymethylcellulose and polylysine). Neither the drug nor the device that are used in this study have been approved by the U.S. Food and Drug Administration (FDA).
Detailed description
This study is for patients with advanced melanoma who are receiving immunotherapy and who are planning to have surgery for their melanoma cancer.
The purpose of this study is to try to figure out the safety of an experimental treatment for melanoma. The experimental treatment is made up of focused ultrasound ablation (FUSA) and an injection in the tumor (intratumoral injection) with an experimental drug called polyICLC (polyinosinic-polycytidylic acid that is stabilized with carboxymethylcellulose and polylysine), also known as Hiltinol, that activates the immune system. The researchers also want to use the results from this clinical trial to help understand how the FUSA and polyICLC affect the tumor cells at the place where the FUSA is given and how much of the surrounding tumor is affected. The experimental treatment in this study is given at the University of Virginia Medical Center about three weeks before the melanoma tumor surgery that would occur as part of the participant's regular care.
FUSA is a non-invasive experimental treatment that uses ultrasound waves to heat and destroy tumor tissue. FUSA is administered using an investigational device. There are two models of the investigational device (Echopulse® or the Echopulse HD®) that will be used in the study to deliver the FUSA. Both devices provide the same type of investigational treatment. Participants are sedated during the FUSA procedure. Up to two tumors will be treated with FUSA.
The polyICLC drug will be given as a one-time injection into one tumor only after the FUSA treatment.
Neither the drug nor the device that are used in this study have been proven to be safe or helpful, and they are not approved by the U.S. Food and Drug Administration (FDA).
This study also includes tumor elastography procedures. Tumor elastography is an ultrasound picture that is taken to measure the stiffness or the flexibility of the tumor. Participants in the study may be asked to have a biopsy of their tumor before starting the study intervention and will be asked participate in optional biopsies of the tumor after enrollment in the study. This study includes collection of blood for research purposes (optional).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FUSA + polyICLC | Experimental | Device: Echopulse or Echopulse HD, Drug: PolyICLCFocused Ultrasound Ablation plus intratumoral injection of polyICLC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age ≥18 years.
- Diagnosis of advanced melanoma planned for surgical resection.
- Focused Ultrasound Ablation (FUSA): The targeted lesion(s) must be visible by ultrasound imaging and meet the following criteria.
- Note: Brain lesions may not be targeted for treatment.
- The target treatment area must be at a safe distance from all critical structures, including but not limited to ribs or other bony structures, vital organs, named blood vessels or nerves.
Key exclusion criteria (24 listed)
- Any of the following medications or treatments are administered to the subject within 4 weeks of study day 1:
- Subject has a known addiction to alcohol or drugs and is actively taking those agents, or has recently (within 1 year) taken these agents or has ongoing illicit IV drug use.
- Subject is known to be HIV positive or has evidence of active Hepatitis B or C virus, unless:
- Pregnancy or breastfeeding. Female participants of childbearing potential must have a negative pregnancy test (urinary or serum beta-HCG) obtained within 2 weeks prior to registration. Males and females must agree, in the consent form, to use effective birth control methods during the course of treatment and following treatment in accordance with the labeling guidelines for each approved therapy.
- Medical contraindications or potential problems that prevent compliance with the requirements of the protocol in the opinion of the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echopulse or Echopulse HDAlso: Focused Ultrasound Ablation, FUSAThe 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. | Device | FUSA + polyICLC |
| PolyICLCAlso: HiltinolPolyICLC (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. | Drug | FUSA + polyICLC |
Primary outcome
Adverse Events
Time frame: Collected from Day 1 up to Day 22
Incidence and severity of adverse events (Common Terminology Criteria for Adverse Events [CTCAE] v5).
Pathologic ablation zone
Time frame: Day 22
Proportion of patients where the size of the pathologic ablation zone is within 20% of the planned zone
1 secondary outcome
Presence of Periablation Zone
Time frame: Day 22
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lynn T Dengel, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Echopulse or Echopulse HD and PolyICLC in people with Advanced Melanoma, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olena Glushakova (434-243-0452, OYG2N@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Collected from Day 1 up to Day 22). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.