protocolSection identificationModule nctId: NCT06388252, orgStudyIdInfo id: ERID-KSOPR-0049/2023, secondaryIdInfos id: 0120-297/2023/3, type: OTHER, domain: National Medical Ethics Committee of the Republic of Slovenia, briefTitle: Electrochemotherapy Induces Changes in the Tumor Microenvironment of Cutaneous and Subcutaneous Metastases in Patients With Cutaneous Melanoma, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-11-10, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Institute of Oncology Ljubljana, class: OTHER, collaborators name: Slovenian Research and Innovation Agency, descriptionModule briefSummary: In the last 10 years, the treatment of metastatic cutaneous melanoma has changed dramatically. The new systemic treatment with immunotherapy has led to a dramatic improvement in quality of life and overall survival. Systemic treatment means that the patient receives the drug as an infusion into a vein. Unfortunately, we know that immunotherapy is not equally successful in all patients. Recent studies have shown that the success of the treatment is not only influenced by the cellular composition of the metastasis, but also by its surroundings. This is called tumor microenvironment. Depending on the differences in the composition of this microenvironment, some metastases can be described as immunologically hot and others as immunologically cold. Immunologically hot metastases respond better to immunotherapy than immunologically cold metastases.Studies have shown that with some interventions we can change the tumor microenvironment from being immune-cold to being immune-hot. Electrochemotherapy is one of the interventions that might improve the efficacy of immunotherapy in cutaneous melanoma. Electrochemotherapy is an established method for the local treatment of tumors, in which only a certain tumor is treated with special electrodes, to which a weak electric current is applied. We hypothesize that electrochemotherapy stimulates the body's own immune response and enables more effective treatment. Since immunotherapy also stimulates the body's own immune response to cutaneous melanoma cells, the interaction of the two drugs could be even more successful. Recent research results support this assumption.The primary objective is to evaluate the changes in the tumor microenvironment of cutaneous and subcutaneous melanoma metastases induced by electrochemotherapy, based on the histologic analysis of treated and untreated metastases before and after treatment. The secondary aim is to determine whether the changes in the tumor microenvironment differ depending on the chemotherapeutic agent used.The results will help us to better understand the synergistic effects of electrochemotherapy and immunotherapy on cutaneous melanoma metastases. The combination of systemic immunotherapy and electrochemotherapy could become an important treatment method for patients with metastatic melanoma., conditionsModule conditions: Cutaneous Malignant Melanoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: Electrochemotherapy with intratumoural cysplatin is recommended for smaller (less than 3 cm) and fewer tumours (up to 10 lesions), while electrochemotherapy with intravenous bleomycin is preferable for multiple and larger tumours., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Electrochemotherapy with Intratumoral Cysplatin, interventions name: Electrochemotherapy with Intravenous Bleomycin, outcomesModule primaryOutcomes measure: Changes in the tumor microenvironment of cutaneoys and subcutaneousm melanoma metastases induced by electrochemotherapy, secondaryOutcomes measure: Diferrent changes in the tumor microenvironment induced by electrochemotherapy with bleomycin or cysplatin, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Oncology Ljubljana, city: Ljubljana, zip: 1000, country: Slovenia, geoPoint lat: 46.05108, lon: 14.50513, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-11-10, uploadDate: 2024-03-20T00:20, filename: ICF_000.pdf, size: 356929, hasResults: False