Multicenter Tissue Registry in Melanoma

Conditions

Metastatic Melanoma

Keywords

melanoma, biomarker, tumor tissue, systemic therapy, immune checkpoint therapy, targeted therapy, PD-L1, Tumor mutational burden

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.

Lodde GC, Zhao F, Herbst R, Terheyden P, Utikal J, Pföhler C, Ulrich J, Kreuter A, Mohr P, Gutzmer R, Meier F, Dippel E, Weichenthal M, Jansen P, Kowall B, Galetzka W, Hörst F, Kleesiek J, Hellwig B, Rahnenführer J, Rajcsanyi L, Peters T, Hinney A, Placke JM, Sucker A, Paschen A, Becker JC, Livingstone E, Zimmer L, Tasdogan A, Roesch A, Hadaschik E, Schadendorf D, Griewank K, Ugurel S.

2024-08-233 citations

10.1016/j.ejca.2024.114295

Correlation of tumor PD-L1 expression in different tissue types and outcome of PD-1-based immunotherapy in metastatic melanoma - analysis of the DeCOG prospective multicenter cohort study ADOREG/TRIM.

Placke JM, Kimmig M, Griewank K, Herbst R, Terheyden P, Utikal J, Pföhler C, Ulrich J, Kreuter A, Mohr P, Gutzmer R, Meier F, Dippel E, Welzel J, Engel DR, Kreft S, Sucker A, Lodde G, Krefting F, Stoffels I, Klode J, Roesch A, Zimmer L, Livingstone E, Hadaschik E, Becker JC, Weichenthal M, Tasdogan A, Schadendorf D, Ugurel S.

2023-09-0437 citations

10.1016/j.ebiom.2023.104774

Interventions

DIAGNOSTIC_TESTmolecular tissue analysis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

\-

Design outcomes

Primary

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

Countries

Germany

Contacts

Primary ContactSelma Ugurel, MD

selma.ugurel@uk-essen.de+49 201 723 85364

Backup ContactDirk Schadendorf, MD

dirk.schadendorf@uk-essen.de+49 201 723 4510

Outcome results

None listed