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New treatment option for Advanced Melanoma
Official title FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma
ClinicalTrials.gov ID: NCT06472661
What this study is testing
What is PolyICLC?
PolyICLC is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced melanoma.
Also referred to as Hiltinol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- In patients with adrenal or pituitary insufficiency replacement steroid doses are allowed.
See the full eligibility criteria
Who can 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. The target treatment area must be at a safe distance from all...
- 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 people target lesion must be amenable to intratumoral injection with polyICLC per the treating clinician's discretion.
- people 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.
- people 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,
- people are not using steroids for at least 7 days prior to registration, except as allowed in Section 5.2. Regardless of dose, however, people who are on a steroid taper for management of brain metastases are not...
- Ability and willingness to give informed consent.
What rules you out
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.