Clinical trial NCT05750511: Multicenter Tissue Registry in Melanoma
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Melanoma
Keywords: melanoma
biomarker
tumor tissue
systemic therapy
immune checkpoint therapy
targeted therapy
PD-L1
Tumor mutational burden
Lead sponsor: Dermatologic Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with metastatic melanoma stage III or IV suitable for systemic treatment

Brief summary: 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: 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: BOR
timeFrame: through study completion, an average of 1 year
measure: PFS
timeFrame: through study completion, an average of 1 year
measure: OS
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Dept. of Dermatology, University Hospital Tuebingen
state: Baden-Württemberg
city: Buxtehude
country: Germany
facility: Department of Dermatology, ElbeKliniken - Klinikum Buxtehude
state: Niedersachsen
city: Homburg/Saar
country: Germany
facility: Department of Dermatology, The Saarland University Hospital
state: Saarland
city: Lübeck
country: Germany
facility: Dept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck
state: Schleswig-Holstein
city: Erfurt
country: Germany
facility: Dept. of Dermatology, Helios Clinic Erfurt
state: Thuringia
city: Augsburg
country: Germany
facility: Department of Dermatology, University Hospital
city: Dresden
country: Germany
facility: Department of Dermatology, University Hospital
city: Essen
country: Germany
facility: Department of dermatology, University Hospital
city: Hannover
country: Germany
facility: Medizinische Hochschule,dermatologische Klinik und Poliklinik
city: Ludwigshafen
country: Germany
facility: Department of Dermatology
city: Mannheim
country: Germany
facility: Skin Cancer Unit, University Hospital
city: Minden
country: Germany
facility: Department of Dermatology, University Hospital
city: Oberhausen
country: Germany
facility: Department of Dermatology
city: Quedlinburg
country: Germany
facility: Department of Dermatology
Study officials:
affiliation: Dermatologic Cooperative Oncology Group
name: Dirk Schadendorf, MD
role: STUDY_CHAIR
References: