Cutaneous Metastatic MelanomaTHT-CMMNCT06894407
Intratumoral Targeted Hyperthermia Therapy (THT) for Stage 3C/3D/4M1 Cutaneous Metastatic Melanoma
A study testing Device: Targeted Hyperthermia Therapy in people with Cutaneous Metastatic Melanoma, run by Sona Nanotech Inc at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Metastatic Melanoma
- What is being tested?
- Device: 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
- 1 siteChile
- Study dates
- 3 Jul 2025to 26 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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.
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- ECOG Performance Status: 0-1
- Life expectancy: ≥6 months
- Participants able and willing to provide written informed consent and comply with the trial protocol.
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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intratumoral Targeted Hyperthermic Therapy (THT) for Stage 3C/3D/4M1 Cutaneous Metastatic Melanoma in Patients With Targetable Cutaneous and/or Sub-cutaneous Tumors
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
- Being tested
- Device: Targeted Hyperthermia Therapy
- Keywords
- Hyperthermia, Gold Nanorods, Targeted Hyperthermia, Cutaneous Metastatic Melanoma Treatment, Near Infrared Light, Immunotherapy
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Targeted Hyperthermia TherapyDevice
Also called Gold Nanorods, Gold Nanoparticles
Intratumoral gold nanorods (SivaRods 2.0) 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: 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 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
Measured: 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
Measured: 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
The EORTC QLQ-C30 is administered before and after treatment and the changed from baseline is used to determine the impact of the treatment on the overall quality of life of the patient.
Measured: 29 days
Number of participants that have a tumor response as assessed clinically and documented by the treating physician
The total number of participants that have a tumor response to targeted hyperthermia therapy as assessed clinically and documented by the treating physician (Complete Clinical Response, Partial Clinical Response, or No Clinical Response or Progression)
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start3 Jul 2025
- Primary completion26 Sep 2025
- Study completion26 Sep 2025
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 (actual)
Sponsor and investigators
- Lead sponsor
- Sona Nanotech Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894407
- Sponsor's protocol ID
- CIP001
- Acronym
- THT-CMM
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2025
- Last updated
- 2 Oct 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intratumoral 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
- NCT06894407
- Acronym / sponsor ID
- THT-CMM / CIP001
- Conditions
- Cutaneous Metastatic Melanoma
- Keywords
- Hyperthermia, Gold Nanorods, Targeted Hyperthermia, Cutaneous Metastatic Melanoma Treatment, Near Infrared Light, Immunotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sona Nanotech IncIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 25 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 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.
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: Device: Targeted Hyperthermia Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 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).
Key exclusion criteria (12 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
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 |
|---|---|---|
| Device: Targeted Hyperthermia TherapyAlso: Gold Nanorods, Gold NanoparticlesIntratumoral gold nanorods (SivaRods 2.0) exposed to Near Infrared Light (860 +/- 10nm) mediated targeted hyperthermia therapy. | Device | Targeted Hyperthermia Therapy |
Primary outcome
Number of participants that successfully complete THT and the number of lesions that successfully achieved intratumoral temperatures of 42-48C
Time frame: 29 days
Total number of participants that successfully complete targeted hyperthermia therapy ie. achieved an intratumoral temperatures between 42-48C for 5 minutes
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 29 days
The total number of participants experiencing adverse events, including serious adverse events, will be monitored and graded according to NCI CTCAE v5.0
2 secondary outcomes
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
Time frame: 29 days
Number of participants that have a tumor response as assessed clinically and documented by the treating physician
Time frame: 29 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Targeted Hyperthermia Therapy in people with Cutaneous Metastatic Melanoma, run by Sona Nanotech Inc at 1 site in Chile.
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 9 inclusion and 12 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: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that successfully complete THT and the number of lesions that successfully achieved intratumoral temperatures of 42-48C (time frame: 29 days). The study lists 2 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 2 Oct 2026.