Electrochemotherapy effects on the tumor environment in cutaneous melanoma
Electrochemotherapy Induces Changes in Tumor Microenvironment of Cutaneous and Subcutaneous Metastases in Patients With Cutaneous Melanoma
This study will test whether electrochemotherapy with intravenous bleomycin or injected cisplatin changes the tumor environment in people with cutaneous or subcutaneous melanoma metastases.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Oncology Ljubljana Academic / other |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT07404605 on ClinicalTrials.gov |
What this trial studies
This is a prospective interventional study enrolling adults with cutaneous or subcutaneous melanoma metastases who are candidates for electrochemotherapy. Participants will receive electrochemotherapy using either intravenous bleomycin or intratumoral cisplatin according to standard clinical practice, with tumor biopsies taken before and after treatment. Collected tissue will undergo histopathology and immunohistochemistry to measure immune cell infiltration, vascular changes, stromal alterations and other microenvironmental markers. Results will compare treated and untreated lesions to characterize how electrochemotherapy alters the tumor microenvironment.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed cutaneous melanoma and cutaneous or subcutaneous metastases that are eligible for electrochemotherapy and able to provide informed consent.
Not a fit: Patients with only internal (visceral) metastases, known contraindications to bleomycin or cisplatin, pregnancy, or severe comorbidities preventing the procedure are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help tailor electrochemotherapy choices and timing to improve local tumor control and symptom relief for patients with skin melanoma metastases.
How similar studies have performed: Electrochemotherapy is an established local treatment with prior reports of tumor responses and immune activation, but comprehensive pre- and post-treatment microenvironment profiling in melanoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older * Histologically confirmed cutaneous melanoma * Presence of cutaneous and/or subcutaneous metastases eligible for electrochemotherapy * Candidate for electrochemotherapy with intravenous bleomycin or intratumoral cisplatin according to standard clinical practice * Ability to provide written informed consent Exclusion Criteria: * Contraindication to electrochemotherapy or study drugs (bleomycin or cisplatin) * Pregnancy or breastfeeding * Severe comorbidities preventing electrochemotherapy * Inability to comply with study procedures
Where this trial is running
Ljubljana
- Institute of Oncology Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Study coordinator: Klavdija Korošec
- Email: kkorosec@onko-i.si
- Phone: +386 31630065
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.