Intratumoral Targeted Hyperthermia Therapy (THT) for Stage 3C/3D/4M1 Cutaneous Metastatic Melanoma

Study acronym: THT-CMM
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Primary endpoint(s) modified Show 6 more changesShow less
    • Completed without a posted recruiting period
    • Primary completion date changed from estimate of Apr 2026 to Sep 26, 2025
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2025 to Jul 3, 2025
    • Eligibility criteria shortened, about 153 words
    • Secondary endpoints: 1 to 2
  2. Eligibility criteria shortened, about 30 wordsv2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sona Nanotech Inc
2 trials monitored
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Melanoma
1,093 trials monitored
See 62 trials at risk
This first-in-human device clinical trial investigates the safety and feasibility of GNR-mediated THT in patients with stage 3C/3D/4M1 cutaneous metastatic melanoma unresponsive to systemic to PD-1 immune checkpoint immunotherapy or in patients who have contraindications to systemic immunotherapy. The primary objective of the study is to evaluate the safety and feasibility of THT treatment, with secondary objectives focused on tumor response to treatment. Patients will receive intratumoral GNR injections, followed by NIR light therapy to induce mild hyperthermia, with intratumoral temperatures monitored to achieve a target range of 42°C to 48°C.
Trial Details
NCT Number NCT06894407
Lead Sponsor Sona Nanotech Inc
Conditions
(from sponsor)		 Cutaneous Metastatic Melanoma
Related terms Hyperthermia
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov