Cutaneous Metastatic MelanomaNCT06870994
Intratumoral Targeted Hyperthermia Therapy (THT) for Cutaneous Metastatic Melanoma
A study testing Targeted Hyperthermia Therapy in people with Cutaneous Metastatic Melanoma, run by Sona Nanotech Inc.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cutaneous Metastatic Melanoma
- What is being tested?
- Targeted Hyperthermia Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16 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;
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- 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-).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Intra-tumoral Targeted Hyperthermic Therapy (THT) for Stage 3C/3D/4M1 Cutaneous Metastatic Melanoma in Patients With Targetable Cutaneous and/or Sub-cutaneous Tumors
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
- Being tested
- Targeted Hyperthermia Therapy
- Keywords
- Hyperthermia, Gold Nanorods, Targeted Hyperthermia, Near Infrared Light, Cutaneous Metastatic Melanoma Treatment, Immunotherapy
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Hyperthermia TherapyDevice
Also called Gold Nanorods, Gold Nanoparticles
Intra-tumoral gold nanorods (SivaRods) exposed to Near Infrared Light (860 +/- 10nm) mediated targeted hyperthermia therapy
| Study group | Role | What they receive |
|---|---|---|
| Targeted Hyperthermia Therapy | Experimental | Not described Receives: Device: Targeted Hyperthermia Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Oct 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sona Nanotech Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nova Scotia Health Authority
- Responsible party
- Sponsor
- Investigators
- Lucy K Helyer, MD, Principal investigator, Nova Scotia Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870994
- Sponsor's protocol ID
- 69231
- Status last verified
- Apr 2026
- First submitted
- 21 Feb 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-tumoral Targeted Hyperthermic Therapy (THT) for Stage 3C/3D/4M1 Cutaneous Metastatic Melanoma in Patients With Targetable Cutaneous and/or Sub-cutaneous Tumors
- ClinicalTrials.gov ID
- NCT06870994
- Acronym / sponsor ID
- 69231
- Conditions
- Cutaneous Metastatic Melanoma
- Keywords
- Hyperthermia, Gold Nanorods, Targeted Hyperthermia, Near Infrared Light, Cutaneous Metastatic Melanoma Treatment, Immunotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sona Nanotech IncIndustry (pharma, biotech, devices)
- Collaborators
- Nova Scotia Health Authority
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targeted Hyperthermia Therapy | Experimental | Device: Targeted Hyperthermia Therapy |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 16 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.
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted Hyperthermia TherapyAlso: Gold Nanorods, Gold NanoparticlesIntra-tumoral gold nanorods (SivaRods) exposed to Near Infrared Light (860 +/- 10nm) mediated targeted hyperthermia therapy | Device | Targeted Hyperthermia Therapy |
Primary outcome
Number of participants that successfully complete THT (maintain intra-tumoral temperatures of 42-48C)
Time frame: 1 year
Total number of participants that successfully complete targeted hyperthermia therapy ie. maintain an intra-tumoral temperatures between 42-48C for 5 minutes
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 1 year
The total number of participants experiencing adverse events, including serious adverse events, will be monitored and graded according to NCI CTCAE v5.0
Number of participants that have a tumor response as assessed by iRECIST 1.1 criteria
Time frame: 1 year
The total number of participants that have a tumor response to targeted hyperthermia therapy as assessed by iRECIST 1.1 criteria
1 secondary outcome
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
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Yes
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Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lucy K Helyer, MD principal investigator
Nova Scotia Health
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Hyperthermia Therapy in people with Cutaneous Metastatic Melanoma, run by Sona Nanotech Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carman Giacomantonio, MD (902-473-6177, carman.giacomantonio@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that successfully complete THT (maintain intra-tumoral temperatures of 42-48C) (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.