Metastatic MelanomaTRIMNCT05750511
Multicenter Tissue Registry in Melanoma
An observational study of Metastatic Melanoma, run by Dermatologic Cooperative Oncology Group at 14 sites in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- molecular tissue analysis
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 14 sitesGermany
- Study dates
- 1 Feb 2014to 1 Feb 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with metastatic melanoma stage III or IV suitable for systemic treatment
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Germany14 sites, 14 recruiting
- Recruiting
Department of Dermatology, University Hospital
Augsburg
Julia Welzel
- Recruiting
Department of Dermatology, ElbeKliniken - Klinikum Buxtehude
Buxtehude, Lower Saxony, 21614
Peter Mohr, MD, +49 4161 7030, p.mohr@elbekliniken.de
Peter Mohr, MD
- Recruiting
Department of Dermatology, University Hospital
Dresden
Friedegund Meier
- Recruiting
Dept. of Dermatology, Helios Clinic Erfurt
Erfurt, Thuringia, 99012
Rudolf herbst, MD, +49-361-7814300
Yvonne Kellner, MD
- Recruiting
Department of dermatology, University Hospital
Essen
Selma Ugurel
- Recruiting
Medizinische Hochschule,dermatologische Klinik und Poliklinik
Hanover, 30449
Inke Grimmelmann, MD, 0049(0)511 92 460
- Recruiting
Department of Dermatology, The Saarland University Hospital
Homburg/Saar, Saarland, 66424
Claudia Pfoehler, MD, +49 6841 3801, hakras@uniklinik-saarland.de
Claudia Pfoehler, MD
- Recruiting
Dept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck
Lübeck, Schleswig-Holstein, D-23538
Patrick Terheyden, MD, +49-451-5002517
Sven Krengel, MD
- Recruiting
Department of Dermatology
Ludwigshafen
Edgar Dippel
- Recruiting
Skin Cancer Unit, University Hospital
Mannheim
Jochen Utikal
- Recruiting
Department of Dermatology, University Hospital
Minden
Ralf Gutzmer
- Recruiting
Department of Dermatology
Oberhausen
Alexander Kreuter
- Recruiting
Department of Dermatology
Quedlinburg
Jens Ulrich
- Recruiting
Dept. of Dermatology, University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, D-72076
Andrea Forschner, MD, +49-7071-2980872, studienzentrum-derm-onko@med.uni-tuebingen.de
Claus Garbe, MD
About this study
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
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.
Read the 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.
- Conditions
- Metastatic Melanoma
- Being tested
- molecular tissue analysis
- Keywords
- melanoma, biomarker, tumor tissue, systemic therapy, immune checkpoint therapy, targeted therapy, PD-L1, Tumor mutational burden
- Medical subject headings
- Melanoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
molecular tissue analysisDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| metastatic melanoma | 1,000 subjects with metastatic melanoma stage III or IV suitable for systemic treatment from centers of the German Dermatologic Cooperative Oncology Group (DeCOG) Receives: Diagnostic Test: molecular tissue analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOR
best overall response (BOR)
Measured: through study completion, an average of 1 year
PFS
progression-free survival (PFS)
Measured: through study completion, an average of 1 year
OS
overall survival (OS)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Feb 2014
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Dermatologic Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dirk Schadendorf, MD, Study chair, Dermatologic Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750511
- Sponsor's protocol ID
- CA209-578
- Acronym
- TRIM
- Status last verified
- Feb 2023
- First submitted
- 18 Feb 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: patients/samples will be pseudonymized/anonymized
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05750511
- Acronym / sponsor ID
- TRIM / CA209-578
- Conditions
- Metastatic Melanoma
- Keywords
- melanoma, biomarker, tumor tissue, systemic therapy, immune checkpoint therapy, targeted therapy, PD-L1, Tumor mutational burden
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Dermatologic Cooperative Oncology GroupUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metastatic melanoma | – | Diagnostic Test: molecular tissue analysis1,000 subjects with metastatic melanoma stage III or IV suitable for systemic treatment from centers of the German Dermatologic Cooperative Oncology Group (DeCOG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with metastatic melanoma stage III or IV suitable for systemic treatment
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| molecular tissue analysis | Diagnostic test | metastatic melanoma |
Primary outcome
BOR
Time frame: through study completion, an average of 1 year
best overall response (BOR)
PFS
Time frame: through study completion, an average of 1 year
progression-free survival (PFS)
OS
Time frame: through study completion, an average of 1 year
overall survival (OS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: No. patients/samples will be pseudonymized/anonymized
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk Schadendorf, MD study chair
Dermatologic Cooperative Oncology Group
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Melanoma, run by Dermatologic Cooperative Oncology Group at 14 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Selma Ugurel, MD (+49 201 723 85364, selma.ugurel@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOR (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023; AzTrials last refreshed its copy on 1 Nov 2026.