RECRUITING

FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma

Conditions

Advanced Melanoma Melanoma Focused Ultrasound polyICLC poly ICLC poly-ICLC Echopulse Echopulse HD Focused Ultrasound Ablation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Pilot Evaluation of Focused Ultrasound Ablation and Intratumoral PolyICLC in Patients With Regionally Advanced Resectable Melanoma Who Are Receiving Neoadjuvant Immunotherapy

Quick Facts

Study Start:2024-09

Study Completion:2026-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06472661

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥18 years. 2. Diagnosis of advanced melanoma planned for surgical resection. 3. Focused Ultrasound Ablation (FUSA): The targeted lesion(s) must be visible by ultrasound imaging and meet the following criteria. 1. Approximately 1 cm (or more) diameter of treatable tumor volume for lesions to be treated with FUSA. 2. 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. 3. 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. 4. The anterior-posterior dimension of the treatment area by US should be no less than 9 mm. 4. A subjects target lesion must be amenable to intratumoral injection with polyICLC per the treating clinician's discretion. 5. Subjects must be receiving checkpoint blockade (either monotherapy or combination therapy) at the time of registration. 6. Biopsies: * 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. 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 8. 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. 9. Ability and willingness to give informed consent.	1. Any of the following medications or treatments are administered to the subject within 4 weeks of study day 1: 1. Radiation therapy (Note: Stereotactic radiotherapy, such as gamma knife, can be used ≥ 1 week prior to registration) 2. Allergy desensitization injections 3. 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. * 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. 4. Growth factors (e.g. Procrit®, Aranesp®, Neulasta®) 5. Interleukins (e.g. Proleukin®) 6. Any investigational therapeutic agent. 7. Targeted therapies specific for mutated BRAF or for MEK 8. Live vaccine 9. Interferon (e.g. Intron-A®) 10. Cytotoxic chemotherapy for cancer 2. 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. 3. 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 4. 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. 5. Medical contraindications or potential problems that prevent compliance with the requirements of the protocol in the opinion of the investigator. 6. Active infection requiring systemic therapy. 7. The presence of Class III or IV heart disease as classified according to the New York Heart Association. 8. History of another cancer * Any cancer with or without metastatic disease that has been treated successfully, without evidence of subsequent recurrence or metastasis for over 2 years * Any cancer without distant metastasis that has been treated successfully, without evidence of recurrence or metastasis for over 2 years * Squamous cell cancer of the skin without known metastasis * Basal cell cancer of the skin without known metastasis * Stage 0 cancers including carcinoma in situ of the breast (DCIS) and melanoma in situ. 9. 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.

Inclusion Criteria

Exclusion Criteria

1. Age ≥18 years.
2. Diagnosis of advanced melanoma planned for surgical resection.
3. Focused Ultrasound Ablation (FUSA): The targeted lesion(s) must be visible by ultrasound imaging and meet the following criteria.
1. Approximately 1 cm (or more) diameter of treatable tumor volume for lesions to be treated with FUSA.
2. 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.
3. 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.
4. The anterior-posterior dimension of the treatment area by US should be no less than 9 mm.
4. A subjects target lesion must be amenable to intratumoral injection with polyICLC per the treating clinician's discretion.
5. Subjects must be receiving checkpoint blockade (either monotherapy or combination therapy) at the time of registration.
6. Biopsies:
* 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.
7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
8. 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.
9. Ability and willingness to give informed consent.

1. Any of the following medications or treatments are administered to the subject within 4 weeks of study day 1:
1. Radiation therapy (Note: Stereotactic radiotherapy, such as gamma knife, can be used ≥ 1 week prior to registration)
2. Allergy desensitization injections
3. 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.
* 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.
4. Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)
5. Interleukins (e.g. Proleukin®)
6. Any investigational therapeutic agent.
7. Targeted therapies specific for mutated BRAF or for MEK
8. Live vaccine
9. Interferon (e.g. Intron-A®)
10. Cytotoxic chemotherapy for cancer
2. 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.
3. 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
4. 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.
5. Medical contraindications or potential problems that prevent compliance with the requirements of the protocol in the opinion of the investigator.
6. Active infection requiring systemic therapy.
7. The presence of Class III or IV heart disease as classified according to the New York Heart Association.
8. History of another cancer
* Any cancer with or without metastatic disease that has been treated successfully, without evidence of subsequent recurrence or metastasis for over 2 years
* Any cancer without distant metastasis that has been treated successfully, without evidence of recurrence or metastasis for over 2 years
* Squamous cell cancer of the skin without known metastasis
* Basal cell cancer of the skin without known metastasis
* Stage 0 cancers including carcinoma in situ of the breast (DCIS) and melanoma in situ.
9. 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.

Contacts and Locations

Study Contact

Olena Glushakova

CONTACT

434-243-0452

OYG2N@uvahealth.org

Principal Investigator

Lynn T Dengel, MD

PRINCIPAL_INVESTIGATOR

University of Virginia

Study Locations (Sites)

University of Virginia

Charlottesville, Virginia, 22908

United States

Collaborators and Investigators

Sponsor: University of Virginia

Lynn T Dengel, MD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09

Study Completion Date2026-08

Study Record Updates

Study Start Date2024-09

Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

Melanoma
Advanced Melanoma
Focused Ultrasound
polyICLC
poly ICLC
poly-ICLC
Echopulse
Echopulse HD
Focused Ultrasound Ablation

Additional Relevant MeSH Terms

Advanced Melanoma