Intratumoral Targeted Hyperthermia Therapy (THT) for Cutaneous Metastatic Melanoma

NCT06870994 | Not Yet Recruiting

• 1 other identifier: 69231
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This device phase I/II, first in human, early feasibility study (EFS), open-label, single-arm trial aims to evaluate the safety, tolerability, and preliminary efficacy of Gold Nanorod (GNR)-enabled sub-ablative targeted hyperthermia therapy (THT) in patients with unresectable stage 3C/3D/4M1 cutaneous metastatic malignant melanoma that have failed to respond to systemic checkpoint and localized intra-tumoral immunotherapy. The study will involve up to 10 participants with stable or progressive cutaneous and/or subcutaneous skin lesions (Immune Stable Disease (iSD) or Immune Confirmed/Unconfirmed Progressive Disease (iCPD/iUPD)). GNRs, when administered via intra-tumoral injection and activated by NIR light, generate localized heat through a process called THT. This approach selectively targets tumor cells while minimizing damage to surrounding healthy tissue. In this study, 10 participants will receive two THT treatments spaced 7 days apart. The primary objective of this study is to assess the safety and tolerability of THT treatment.

Conditions

Cutaneous Metastatic Melanoma

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  1 year

Secondary Outcomes (1)

• 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

  1 year

Study Arms (1)

Targeted Hyperthermia Therapy

EXPERIMENTAL

Device: Targeted Hyperthermia Therapy

Interventions

Targeted Hyperthermia Therapy DEVICE

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

Also known as: Gold Nanorods, Gold Nanoparticles

Targeted Hyperthermia Therapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), 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 iRECIST 1.1 criteria, 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 ≤2.5 cm in diameter;
• Participants must have received and failed systemic and local intra-tumoral therapy at least one prior standard therapy, including immune checkpoint inhibitors (e.g., anti- PD1 or anti-CTLA-4), and failed local intra-tumoral IL-2 treatment. Failed response to treatment will be categorized according to iRECIST guidelines. Patients who have: a) Immune partial response (iPR): At least a 30% decrease in the sum of diameters of target lesions compared to baseline, no progression of non-target lesions, No new lesions; or b) Immune Stable Disease (iSD): Neither sufficient reduction to qualify for iPR nor sufficient increase to qualify for iCPD (immune confirmed progressive disease), no new lesions; or c) Immune Unconfirmed Progressive Disease (iUPD): At least a 20% increase in the sum of diameters of target lesions, taking the smallest sum on study as the reference, appearance of new lesions, iUPD needs confirmation after at least 4 weeks; if confirmed, it becomes iCPD; or d) Immune Confirmed Progressive Disease (iCPD): iUPD must be confirmed in a follow-up assessment (minimum of 4 weeks after initial iUPD), if progressive disease (increase in lesion size or additional new lesions) is still evident upon re-evaluation, iCPD is confirmed.
• Participants must agree to discontinue treatment with local intralesional immunotherapies during the study, with resumption after completion of the trial;
• ECOG Performance Status: ≤1;
• Life expectancy: ≥6 months;
• Participants able and willing to provide written informed consent and comply with the trial protocol.
• Either BRAF positive (BRAF+) or BRAF negative (BRAF-).

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
• Nova Scotia Health Authority: collaborator

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 Officials

• Lucy K Helyer, MD

  Nova Scotia Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carman Giacomantonio, MD

CONTACT

902-473-6177; carman.giacomantonio@nshealth.ca

Len Pagliaro, PhD

CONTACT

+1 (425) 443-4344; len@sonanano.com

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: February 21, 2025
• First Posted: March 11, 2025
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share