Multicenter Tissue Registry in Melanoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Multicenter Translational Study to Validate Molecular Biomarkers (TMB, PD-L1) on Pre-treatment Tumor Tissue as Predictors of Therapy Outcome in Metastatic Melanoma Patients

Conditions
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Metastatic Melanoma

Intervention / Treatment
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* Diagnostic Test: molecular tissue analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically confirmed melanoma stage III or IV. Clinically eligible for systemic cancer therapy (immune checkpoint inhibitors, targeted agents). Tumor tissue biopsy already existing (metastasis tissue as recent as possible, but older tissue material or primary tumor tissue also possible). 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. Patient is ≥18 years old. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| metastatic melanoma<br>1,000 subjects with metastatic melanoma stage III or IV suitable for systemic treatment from centers of the German Dermatologic Cooperative Oncology Group (DeCOG) | Diagnostic Test: molecular tissue analysis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BOR | best overall response (BOR) | through study completion, an average of 1 year | 
| PFS | progression-free survival (PFS) | through study completion, an average of 1 year | 
| OS | overall survival (OS) | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melanoma, biomarker, tumor tissue, systemic therapy, immune checkpoint therapy, targeted therapy, PD-L1, Tumor mutational burden