Intra-tumoral Targeted Hyperthermic Therapy (THT) for Stage 3C/3D/4M1 Cutaneous Metastatic Melanoma in Patients With Targetable Cutaneous and/or Sub-cutaneous Tumors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Number of participants that successfully complete THT (maintain intra-tumoral temperatures of 42-48C)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •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-).
排除标准
- •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.
研究组 & 干预措施
Targeted Hyperthermia Therapy
干预措施: Targeted Hyperthermia Therapy (Device)
结局指标
主要结局
Number of participants that successfully complete THT (maintain intra-tumoral temperatures of 42-48C)
时间窗: 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
时间窗: 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
时间窗: 1 year
The total number of participants that have a tumor response to targeted hyperthermia therapy as assessed by iRECIST 1.1 criteria
次要结局
- 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)