Clinical trial · Observational
Multicenter Tissue Registry in Melanoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| molecular tissue analysis | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- metastatic melanoma
- description
- 1,000 subjects with metastatic melanoma stage III or IV suitable for systemic treatment from centers of the German Dermatologic Cooperative Oncology Group (DeCOG)
- interventionNames
- Diagnostic Test: molecular tissue analysis
Primary outcomes (3)
- measure
- BOR
- timeFrame
- through study completion, an average of 1 year
- description
- best overall response (BOR)
- measure
- PFS
- timeFrame
- through study completion, an average of 1 year
- description
- progression-free survival (PFS)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: \-
References
Publications (0)
Data not yet available