Status:
RECRUITING
Biomarkers in Immunotherapy of Melanoma
Lead Sponsor:
Institute of Oncology Ljubljana
Collaborating Sponsors:
Blood Transfusion Centre of Slovenia
University Medical Centre Ljubljana
Conditions:
Metastatic Melanoma
Immune Checkpoints Inhibitors
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background: Immunotherapy has been successful in treating advanced melanoma, but a large proportion of patients do not respond to the treatment with immune checkpoint inhibitors (ICIs). Preclinical an...
Detailed Description
The goal of this \[type of study: observational study or clinical trial\] is to \[learn about, test, compare etc.\] in \[describe participant population/health conditions\]. The main question\[s\] it ...
Eligibility Criteria
Inclusion Criteria:
- Age over 18 years
- Cytologically or histologically verified malignant melanoma
- Stage IIID unresectable/IV according to AJCC classification (8th edition, 2018)
- Performance status according to WHO 0 - 2 (ECOG criteria)
- 1st line of systemic treatment with immunotherapy (nivolumab, ipi/nivo, pembrolizumab)
- Triple CT/PET CT done within 4 weeks before the first application
- Signed consent to participate in clinical research
Exclusion Criteria:
- Previously treated melanoma with systemic therapy
- Capacity status according to WHO 3 - 4 (ECOG criteria)
- Contraindications for immunotherapy treatment (known deficiency of the immune system or active immunosuppressive treatment or active autoimmune disease requiring treatment)
- Other malignant diseases (except cured basal cell carcinoma and squamous cell carcinoma)
Key Trial Info
Start Date :
October 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05878977
Start Date
October 5 2022
End Date
December 31 2027
Last Update
October 18 2024
Active Locations (1)
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1
Institute of Oncology Ljubljana
Ljubljana, Slovenia