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

NCT06894407 | Completed

• 1 other identifier: CIP001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cutaneous Metastatic Melanoma

Keywords

Hyperthermia; Gold Nanorods; Targeted Hyperthermia; Cutaneous Metastatic Melanoma Treatment; Near Infrared Light; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• Number of participants that successfully complete THT and the number of lesions that successfully achieved intratumoral temperatures of 42-48C

  Total number of participants that successfully complete targeted hyperthermia therapy ie. achieved an intratumoral temperatures between 42-48C for 5 minutes

  29 days

• 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

  29 days

Secondary Outcomes (2)

• Patient acceptance and tolerability of treatment as assessed by standardized quality of life assessment tools (EORTC QLQ-C30) before and after THT treatment is completed

  29 days

• Number of participants that have a tumor response as assessed clinically and documented by the treating physician

  29 days

Study Arms (1)

Targeted Hyperthermia Therapy

EXPERIMENTAL

Device: Device: Targeted Hyperthermia Therapy

Interventions

Device: Targeted Hyperthermia Therapy DEVICE

Intratumoral gold nanorods (SivaRods 2.0) exposed to Near Infrared Light (860 +/- 10nm) mediated targeted hyperthermia therapy.

Also known as: Gold Nanorods, Gold Nanoparticles

Targeted Hyperthermia Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 qualify 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.

Sponsors & Collaborators

• Sona Nanotech Inc: lead

Study Sites (1)

Bradford Hill

Santiago, Recoleta, Palestina 343, Chile

Location

MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: July 3, 2025
• Primary Completion: September 26, 2025
• Study Completion: September 26, 2025
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

CL (1)