Multicenter Tissue Registry in Melanoma

Metastatic Melanoma Clinical Trial

— TRIM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05750511
• Other study ID #: CA209-578
• Status: Recruiting
• Start date: February 1, 2014
• Est. completion date: February 1, 2025

Study information

• Verified date: February 2023
• Source: Dermatologic Cooperative Oncology Group
• Contact: Selma Ugurel, MD
• Phone: +49 201 723 85364
• Email: selma.ugurel[@]uk-essen.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Diagnostic Test:
• molecular tissue analysis

Locations

Country	Name	City	State
Germany	Department of Dermatology, University Hospital	Augsburg
Germany	Department of Dermatology, ElbeKliniken - Klinikum Buxtehude	Buxtehude	Niedersachsen
Germany	Department of Dermatology, University Hospital	Dresden
Germany	Dept. of Dermatology, Helios Clinic Erfurt	Erfurt	Thuringia
Germany	Department of dermatology, University Hospital	Essen
Germany	Medizinische Hochschule,dermatologische Klinik und Poliklinik	Hannover
Germany	Department of Dermatology, The Saarland University Hospital	Homburg/Saar	Saarland
Germany	Dept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck	Lübeck	Schleswig-Holstein
Germany	Department of Dermatology	Ludwigshafen
Germany	Skin Cancer Unit, University Hospital	Mannheim
Germany	Department of Dermatology, University Hospital	Minden
Germany	Department of Dermatology	Oberhausen
Germany	Department of Dermatology	Quedlinburg
Germany	Dept. of Dermatology, University Hospital Tuebingen	Tuebingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Dermatologic Cooperative Oncology Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BOR	best overall response (BOR)	through study completion, an average of 1 year
Primary	PFS	progression-free survival (PFS)	through study completion, an average of 1 year
Primary	OS	overall survival (OS)	through study completion, an average of 1 year