Charlottesville, VANCT06472661Now EnrollingIRB Ready

Advanced Melanoma Clinical Trial in Charlottesville, VA

Access cutting-edge advanced melanoma treatment through this clinical trial at a research site in Charlottesville. Study-provided care at no cost to qualified participants.

Sponsored by University of Virginia

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Expert Care in Charlottesville

Access advanced melanoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related advanced melanoma treatment provided free

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Check if you qualify for this advanced melanoma clinical trial in Charlottesville, VA

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Why Participate?

  • No-Cost Study Care

  • Local to Charlottesville

    Convenient for VA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Charlottesville site if eligible
  4. 4Begin participation

About This Advanced Melanoma Study in Charlottesville

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).

Sponsor: University of Virginia

Who Can Participate

Inclusion Criteria

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. 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.

Exclusion Criteria

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.
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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Charlottesville?

Yes, this clinical trial (NCT06472661) has an active research site in Charlottesville, VA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Advanced Melanoma Treatment Options in Charlottesville, VA

If you're searching for advanced melanoma treatment options in Charlottesville, VA, this clinical trial (NCT06472661) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Charlottesville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced advanced melanoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all advanced melanoma clinical trials near you to find additional studies recruiting in your area.

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