Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:28 PM
Study NCT ID:
NCT07404605
Status:
RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrochemotherapy-Induced Changes in Tumor Microenvironment in Cutaneous Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053672', 'term': 'Electrochemotherapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000092722', 'term': 'Electroporation Therapies'}, {'id': 'D018274', 'term': 'Electroporation'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-arm prospective interventional study evaluating tumor microenvironment changes in melanoma metastases before and after electrochemotherapy.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-02-04', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Tumor Microenvironment Biomarker Panel After Electrochemotherapy', 'timeFrame': 'Baseline (pre-treatment) and post-treatment (up to 3 months after electrochemotherapy)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Difference in Tumor Microenvironment Biomarkers Between Treated and Untreated Lesions', 'timeFrame': 'Up to 3 months after electrochemotherapy', 'description': 'Comparison of a predefined panel of tumor microenvironment biomarkers (including immune cell infiltration markers and vascular markers) between electrochemotherapy-treated lesions and untreated lesions in the same patient.'}, {'measure': 'Local Tumor Control Rate After Electrochemotherapy', 'timeFrame': 'Up to 12 months after electrochemotherapy', 'description': 'Local tumor control of electrochemotherapy-treated cutaneous and subcutaneous melanoma metastases assessed clinically and/or radiologically.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MELANOMA'], 'conditions': ['MELANOMA', 'SKIN NEOPLASMS']}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nThe 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.\n\nThe results of this study may improve understanding of biological effects of electrochemotherapy in melanoma metastases and support further development of treatment strategies.', 'detailedDescription': 'This is a prospective interventional clinical study designed to investigate electrochemotherapy-induced changes in the tumor microenvironment of cutaneous and subcutaneous melanoma metastases.\n\nElectrochemotherapy is a local treatment approach that combines electroporation with cytotoxic agents in order to increase intracellular drug delivery and enhance tumor cell death. The treatment is routinely used for superficial tumor lesions, including melanoma metastases, and can be performed using intravenous bleomycin or intratumoral cisplatin.\n\nThe primary objective of this study is to characterize changes in the tumor microenvironment in melanoma metastases following electrochemotherapy. Tumor tissue samples will be collected from untreated lesions and from lesions treated with electrochemotherapy. Histopathological and immunohistochemical analyses will be performed to evaluate changes in the tumor microenvironment, including cellular and stromal components, immune-related features, and other relevant biological markers.\n\nThe study will include patients with cutaneous melanoma presenting with cutaneous and/or subcutaneous metastases who are eligible for electrochemotherapy as part of their clinical management. Electrochemotherapy will be performed according to established clinical procedures using intravenous bleomycin or intratumoral cisplatin. Biopsy or surgical samples will be collected before and after treatment to enable comparative analyses of treated and untreated tumor tissue.\n\nCollected clinical and pathological data will be used to assess associations between treatment-related microenvironmental changes and patient and lesion characteristics. The study aims to provide additional insight into biological effects of electrochemotherapy beyond local tumor control and may contribute to improved understanding of mechanisms involved in treatment response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Histologically confirmed cutaneous melanoma\n* Presence of cutaneous and/or subcutaneous metastases eligible for electrochemotherapy\n* Candidate for electrochemotherapy with intravenous bleomycin or intratumoral cisplatin according to standard clinical practice\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Contraindication to electrochemotherapy or study drugs (bleomycin or cisplatin)\n* Pregnancy or breastfeeding\n* Severe comorbidities preventing electrochemotherapy\n* Inability to comply with study procedures'}, 'identificationModule': {'nctId': 'NCT07404605', 'briefTitle': 'Electrochemotherapy-Induced Changes in Tumor Microenvironment in Cutaneous Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Oncology Ljubljana'}, 'officialTitle': 'Electrochemotherapy Induces Changes in Tumor Microenvironment of Cutaneous and Subcutaneous Metastases in Patients With Cutaneous Melanoma', 'orgStudyIdInfo': {'id': 'OI-EKT-MEL-2023'}, 'secondaryIdInfos': [{'id': '0120-297/2023/3', 'type': 'OTHER', 'domain': 'KME Slovenia'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electrochemotherapy (ECT)', 'description': '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.', 'interventionNames': ['Procedure: Electrochemotherapy']}], 'interventions': [{'name': 'Electrochemotherapy', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Electrochemotherapy (ECT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Korošec', 'role': 'CONTACT', 'email': 'kkorosec@onko-i.si', 'phone': '+386 31630065'}, {'name': 'Neža Gros', 'role': 'CONTACT', 'email': 'ngros@onko-i.si'}], 'facility': 'Institute of Oncology Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Klavdija Korošec', 'role': 'CONTACT', 'email': 'kkorosec@onko-i.si', 'phone': '+386 31630065'}, {'name': 'Neža Gros', 'role': 'CONTACT', 'email': 'ngros@onko-i.si'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Oncology Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}