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Keep this study
Lead
Sona Nanotech Inc
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
18 years of age or older
Participants with histologically or cytologically confirmed stage 3C/3D/4M1 advanced or cutaneous metastatic melanoma, with measurable disease by standard histological methods (not iRECIST) including any number of cutaneous lesions
Present a visible and accessible primary tumor or metastatic deposit (any site) that has not been surgically removed
Present target tumors of 0.5 -2.5 cm in diameter
Participants must have received and failed (progressed) following at least one prior standard therapy, including immune checkpoint inhibitors (e.g., anti- PD1 or anti-CTLA-4).
Response is determined by clinical assessment and photo documentation.
ECOG Performance Status: 0-1
Life expectancy: ≥6 months
Participants able and willing to provide written informed consent and comply with the trial protocol.
You may not be if
Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
Women of childbearing potential must have a negative pregnancy test within 72 hours prior to enrollment and agree to use adequate contraception throughout the study
Any infection requiring systemic therapy or other concurrent medical conditions (e.g., hepatitis B, hepatitis C, HIV) that would interfere with the study
Myocardial infarction or stroke within the past 6 months, uncontrolled angina, or significant arrhythmia
Participants receiving blood thinners as part of therapeutic anticoagulation therapy
Any severe or uncontrolled comorbid condition that, in the investigator's opinion, would pose excessive risk to the participants (e.g., immunodeficiencies, severe hypertension, uncontrolled diabetes, liver failure)
Participation in another clinical trial involving an investigational product/device within 30 days prior to screening
Any condition that would impede compliance with study procedures
Participants with a known allergy to gold of any kind
Participants who are unable to tolerate cutaneous injections for any reason will not be eligible
Participants with a known allergy to injectable local analgesics
Participants with ocular melanoma or melanoma involving periorbital skin.
Clareo Health | Intratumoral Targeted Hyperthermia Therapy (THT) for Stage 3C/3D/4M1 Cutaneous Metastatic Melanoma
