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).
• 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.