Electrochemotherapy-Induced Changes in Tumor Microenvironment in Cutaneous Melanoma

NCT07404605 | Recruiting

• 2 other identifiers: OI-EKT-MEL-20230120-297/2023/3
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Cutaneous melanoma frequently develops cutaneous and subcutaneous metastases, which may cause significant morbidity and negatively affect quality of life. Electrochemotherapy (ECT) is an established local treatment modality for cutaneous and subcutaneous tumor lesions that combines the administration of cytotoxic drugs with the application of electric pulses to increase drug uptake into tumor cells. In addition to its direct cytotoxic effects, electrochemotherapy may induce changes in the tumor microenvironment, including immune cell infiltration, vascular alterations, and other biological responses that could influence tumor control. The aim of this study is to evaluate changes in the tumor microenvironment of cutaneous and subcutaneous melanoma metastases following electrochemotherapy with either intravenous bleomycin or intratumoral cisplatin. Tumor tissue samples collected before and after treatment will be analyzed to characterize microenvironmental changes and to compare treated and untreated lesions. The results of this study may improve understanding of biological effects of electrochemotherapy in melanoma metastases and support further development of treatment strategies.

Conditions

MELANOMA; SKIN NEOPLASMS

Keywords

MELANOMA

Outcome Measures

Primary Outcomes (1)

• Change in Tumor Microenvironment Biomarker Panel After Electrochemotherapy

  Change in a predefined panel of tumor microenvironment biomarkers assessed by histopathology and immunohistochemistry in tumor tissue samples collected before and after electrochemotherapy. Biomarkers include immune cell infiltration markers and vascular markers. Results will be reported separately for each biomarker.

  Baseline (pre-treatment) and post-treatment (up to 3 months after electrochemotherapy)

Secondary Outcomes (2)

• Difference in Tumor Microenvironment Biomarkers Between Treated and Untreated Lesions

  Up to 3 months after electrochemotherapy

• Local Tumor Control Rate After Electrochemotherapy

  Up to 12 months after electrochemotherapy

Study Arms (1)

Electrochemotherapy (ECT)

EXPERIMENTAL

Patients with cutaneous melanoma with cutaneous and/or subcutaneous metastases undergoing electrochemotherapy as part of clinical management. Electrochemotherapy is performed using intravenous bleomycin or intratumoral cisplatin. Tumor samples are collected before and after treatment for analysis of tumor microenvironment changes.

Procedure: Electrochemotherapy

Interventions

Electrochemotherapy PROCEDURE

Electrochemotherapy is performed according to standard clinical procedures with application of electric pulses combined with administration of cytotoxic agents (intravenous bleomycin or intratumoral cisplatin) for treatment of cutaneous and subcutaneous melanoma metastases.

Electrochemotherapy (ECT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindication to electrochemotherapy or study drugs (bleomycin or cisplatin)
• Pregnancy or breastfeeding
• Severe comorbidities preventing electrochemotherapy
• Inability to comply with study procedures

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Melanoma; Skin Neoplasms

Interventions

Electrochemotherapy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Electroporation Therapies; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Central Study Contacts

Klavdija Korošec

CONTACT

+386 31630065; kkorosec@onko-i.si

Neža Gros

CONTACT

ngros@onko-i.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm prospective interventional study evaluating tumor microenvironment changes in melanoma metastases before and after electrochemotherapy.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: September 1, 2023
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)