Intratumoral Targeted Hyperthermia Therapy (THT) for Cutaneous Metastatic Melanoma

NCT ID: NCT06870994

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Targeted Hyperthermia Therapy

Group Type: EXPERIMENTAL

Targeted Hyperthermia Therapy

Intervention Type: DEVICE

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

Interventions

Targeted Hyperthermia Therapy

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

Intervention Type: DEVICE

Other Intervention Names

Gold Nanorods; Gold Nanoparticles

Eligibility Criteria

Inclusion Criteria

1. 16 years of age or older;

2. 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;

3. Present a visible and accessible primary tumor or metastatic deposit (any site) that has not been surgically removed;

4. Present target tumors of ≤2.5 cm in diameter;

5. 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.

6. Participants must agree to discontinue treatment with local intralesional immunotherapies during the study, with resumption after completion of the trial;

7. ECOG Performance Status: ≤1;

8. Life expectancy: ≥6 months;

9. Participants able and willing to provide written informed consent and comply with the trial protocol.

10. Either BRAF positive (BRAF+) or BRAF negative (BRAF-).

Exclusion Criteria

1. 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;

2. Any infection requiring systemic therapy or other concurrent medical conditions (e.g., hepatitis B, hepatitis C, HIV) that would interfere with the study;

3. Myocardial infarction or stroke within the past 6 months, uncontrolled angina, or significant arrhythmia;

4. Participants receiving blood thinners as part of therapeutic anticoagulation therapy;

5. 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);

6. Participation in another clinical trial involving an investigational product/device within 30 days prior to screening;

7. Any condition that would impede compliance with study procedures;

8. Participants with a known allergy to gold of any kind;

9. Participants who are unable to tolerate cutaneous injections for any reason will not be eligible;

10. Participants with a known allergy to injectable local analgesics;

11. Participants with ocular melanoma or melanoma involving periorbital skin.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: collaborator

Sona Nanotech Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lucy K Helyer, MD

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health

Central Contacts

Carman Giacomantonio, MD

Role: CONTACT

carman.giacomantonio@nshealth.ca

902-473-6177

Len Pagliaro, PhD

Role: CONTACT

len@sonanano.com

+1 (425) 443-4344

Other Identifiers

69231

Identifier Type: -

Identifier Source: org_study_id