This phase I/II device clinical trial investigates the safety and efficacy of GNR-mediated THT in patients with stage 3C/3D/4M1 cutaneous metastatic melanoma unresponsive to systemic checkpoint immunotherapy or in patients who have contraindications to systemic immunotherapy. The primary objective of the study is to evaluate the safety of THT treatment, with secondary objectives focused on tumor response to treatment. Patients will receive intra-tumoral GNR injections, followed by NIR light therapy to induce mild hyperthermia, with intra-tumoral temperatures monitored to achieve a target range of 42°C to 48°C. The trial aims to establish a safe, effective dose of GNRs for THT therapy for cutaneous metastatic melanoma treatment and explore the potential for its localized tumor destruction.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
Intra-tumoral gold nanorods (SivaRods) exposed to Near Infrared Light (860 +/- 10nm) mediated targeted hyperthermia therapy.
Number of participants that successfully complete THT (maintain intra-tumoral temperatures of 42-48C)
Total number of participants that successfully complete targeted hyperthermia therapy ie. maintain an intra-tumoral temperatures between 42-48C for 5 minutes
Time frame: 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
The total number of participants experiencing adverse events, including serious adverse events, will be monitored and graded according to NCI CTCAE v5.0
Time frame: 1 year
Number of participants that have a tumor response as assessed by iRECIST 1.1 criteria
The total number of participants that have a tumor response to targeted hyperthermia therapy as assessed by iRECIST 1.1 criteria
Time frame: 1 year
Number of participant's that have an increase in immune cell infiltrates in the tumor biopsy and blood samples post THT compared to pre-treatment patient samples
The total number of participants that have an increase in immune cell infiltrates in their tumor biopsy and blood samples following targeted hyperthermia therapy compared to patients biopsy and blood samples obtained before treatment
Time frame: 1 year
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