The prospective multicenter translational study Tissue Registry in Melanoma (ADOREG/TRIM; CA209-578) aimed to validate the Tumor Mutational Burden (TMB) and the PD-L1 expression (PD-L1) from a pre-therapeutically obtained tumor tissue sample as a predictor of a subsequent systemic therapy in a large real-world cohort of metastatic melanoma patients.

The aim of the present study is to identify and validate molecular and clinical biomarkers of therapy outcome in metastatic melanoma. Clinical and molecular parameters of melanoma patients and their tumors will be collected in an online-based registry (ADOREG), and thereafter correlated with the outcome of subsequent systemic therapies in terms of progression-free survival, overall survival, and treatment response. Systemic therapies will include all types of currently used regimens (kinase inhibitors, immune checkpoint inhibitors, chemotherapy). FFPE tissue samples will comprise different time points (primary tumors versus metastases) as well as tumor sites (lymph node versus organ metastases) to identify potential differences in the predictive value of these materials. The anticipated results from these analyses are of essential importance for future patient selection for individualized therapy strategies.

Inclusion Criteria:

1. Patients with histologically confirmed melanoma stage III or IV.
2. Clinically eligible for systemic cancer therapy (immune checkpoint inhibitors, targeted agents).
3. Tumor tissue biopsy already existing (metastasis tissue as recent as possible, but older tissue material or primary tumor tissue also possible).
4. Patient has given written informed consent for the current study as well as for his data to be entered into the ADOREG online database system.
5. Patient is ≥18 years old.

Exclusion Criteria:

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Subjects with metastatic melanoma stage III or IV suitable for systemic treatment

patients/samples will be pseudonymized/anonymized