MelanomaTREAT20plusNCT05063058
Biomarker-driven Therapy for Melanoma
A study testing Molecular guided therapy in people with Melanoma, run by Charite University, Berlin, Germany.
Trial summary
Patients included will undergo biopsy and the molecular analysis will be discussed at the institutional molecular tumor board. The recommandation of the molecular tumor board will be provided to the physician in charge of the patient for final treatment desicion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Molecular guided therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Aug 2021
- Phase
- Interventional
- 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
Who may be able to join
- histologically proven metastatic melanoma failing standard treatments
- age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- life expectancy ≥ 24 weeks
- adequate renal, liver, and bone marrow functions
Who cannot join
- history of cardiac disease or metastatic brain or meningeal tumors
About this study
Official title: Feasibility Study of Biomarker-driven Therapy Based on a Comprehensive Molecular Analysis of Tumor Tissue and Blood Collections in Melanoma
Patients included will undergo biopsy and the molecular analysis will be discussed at the institutional molecular tumor board. The recommandation of the molecular tumor board will be provided to the physician in charge of the patient for final treatment desicion.
The main endpoints are the number of patients with actionable molecular alterations, the number of patients with a treatment recommendation, the number of patients receiving the recommended therapy, overall survival of the patients treated according to recommendations or not. For patients treated according to the recommendations: Response rate and progression free survival at 6 months according to RECIST criteria.
Read the detailed description
Eligible patients have to have a histologically proven metastatic melanoma failing standard treatments. Other inclusion criteria included age ≥ 18 years; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; life expectancy ≥ 24weeks; adequate renal, liver, and bone marrow functions. Previous therapy with intravenous chemotherapy, immunotherapy or major surgery at least 4 weeks before inclusion was allowed. Patients were excluded if they had a history of cardiac disease or metastatic brain or meningeal tumors. The study is approved by the institutional research ethics board.
Molecular analysis is performed at the Max Planck Institute for Molecular Genetics Berlin and a comprehensive report is made available with 4-8 weeks. The molecular tumor board interprets the data and transforms them into treatment recommendations by identifying and prioritizing predictive biomarkers. The recommendations rely on the definition of evidence levels attributed to every single aberration and the interdisciplinary discussion of the aberrations with regard to patient situation, availability of drugs, and clinical trials. The recommendations are transmitted to the physician in charge of the patient for the final decision to treat or not the patient accordingly.
The main endpoints are the number of patients with actionable molecular alterations, the number of patients with a treatment recommendation, the number of patients receiving the recommended therapy, overall survival of patients treated according to recommendations or not.
For patients treated according to the recommendations: Response rate and progression free survival at 6 months according to RECIST criteria.
- Conditions
- Melanoma
- Being tested
- Molecular guided therapy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular guided therapyDrug
Biomarker-driven therapy according to recommandations of the precision oncology tumor board including MEK Inhibitors (Trametinib 2 mg/d, Selumetinib 75 mg 2/d), MET Inhibitors (Crizotinib 250 mg 2/d, or Cabozantinib 60mg/d), RAS Inhibitor (Sorafenib 400 mg 2/d), Cell cycle Inhibitor (Palbociclib 125 mg/d) and Checkpoint Inhibitor (Nivolumab 240 mg every 2 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Molecular guided therapy | Experimental | Not described Receives: Drug: Molecular guided therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (actionable molecular alterations)
number of patients with actionable molecular alterations
Measured: Through study completion over 5 years
Feasibility (number of patients with a treatment recommendation)
number of patients with a treatment recommendation
Measured: Through study completion over 5 years
Feasibility (number of patients receiving the recommended therapy)
number of patients receiving the recommended therapy
Measured: Through study completion over 5 years
Secondary outcomes (3)
Overall survival
Overall survival
Measured: 5 years
Response rate
Response rate of the patients treated according to the recommendations
Measured: 1 year
Progression free survival at 6 months according to RECIST criteria
PFS according to RECIST criteria for the patients treated according to the recommendations
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study startJan 2016
- Primary completionNov 2019
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Max-Planck Institut, Alacris
- Responsible party
- Principal investigator, Ulrich Keilholz, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063058
- Sponsor's protocol ID
- TREAT20plus
- Acronym
- TREAT20plus
- Status last verified
- Sep 2021
- First submitted
- 26 Aug 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Biomarker-driven Therapy Based on a Comprehensive Molecular Analysis of Tumor Tissue and Blood Collections in Melanoma
- ClinicalTrials.gov ID
- NCT05063058
- Acronym / sponsor ID
- TREAT20plus / TREAT20plus
- Conditions
- Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Max-Planck Institut, Alacris
- Study start
- Jan 2016 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 30 Sep 2021 (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.
Patients included will undergo biopsy and the molecular analysis will be discussed at the institutional molecular tumor board. The recommandation of the molecular tumor board will be provided to the physician in charge of the patient for final treatment desicion.
The main endpoints are the number of patients with actionable molecular alterations, the number of patients with a treatment recommendation, the number of patients receiving the recommended therapy, overall survival of the patients treated according to recommendations or not. For patients treated according to the recommendations: Response rate and progression free survival at 6 months according to RECIST criteria.
Detailed description
Eligible patients have to have a histologically proven metastatic melanoma failing standard treatments. Other inclusion criteria included age ≥ 18 years; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; life expectancy ≥ 24weeks; adequate renal, liver, and bone marrow functions. Previous therapy with intravenous chemotherapy, immunotherapy or major surgery at least 4 weeks before inclusion was allowed. Patients were excluded if they had a history of cardiac disease or metastatic brain or meningeal tumors. The study is approved by the institutional research ethics board.
Molecular analysis is performed at the Max Planck Institute for Molecular Genetics Berlin and a comprehensive report is made available with 4-8 weeks. The molecular tumor board interprets the data and transforms them into treatment recommendations by identifying and prioritizing predictive biomarkers. The recommendations rely on the definition of evidence levels attributed to every single aberration and the interdisciplinary discussion of the aberrations with regard to patient situation, availability of drugs, and clinical trials. The recommendations are transmitted to the physician in charge of the patient for the final decision to treat or not the patient accordingly.
The main endpoints are the number of patients with actionable molecular alterations, the number of patients with a treatment recommendation, the number of patients receiving the recommended therapy, overall survival of patients treated according to recommendations or not.
For patients treated according to the recommendations: Response rate and progression free survival at 6 months according to RECIST criteria.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Molecular guided therapy | Experimental | Drug: Molecular guided therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- histologically proven metastatic melanoma failing standard treatments
- age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- life expectancy ≥ 24 weeks
- adequate renal, liver, and bone marrow functions
Key exclusion criteria (1 listed)
- history of cardiac disease or metastatic brain or meningeal tumors
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 guided therapyBiomarker-driven therapy according to recommandations of the precision oncology tumor board including MEK Inhibitors (Trametinib 2 mg/d, Selumetinib 75 mg 2/d), MET Inhibitors (Crizotinib 250 mg 2/d, or Cabozantinib 60mg/d), RAS Inhibitor (Sorafenib 400 mg 2/d), Cell cycle Inhibitor (Palbociclib 125 mg/d) and Checkpoint Inhibitor (Nivolumab 240 mg every 2 weeks). | Drug | Molecular guided therapy |
Primary outcome
Feasibility (actionable molecular alterations)
Time frame: Through study completion over 5 years
number of patients with actionable molecular alterations
Feasibility (number of patients with a treatment recommendation)
Time frame: Through study completion over 5 years
number of patients with a treatment recommendation
Feasibility (number of patients receiving the recommended therapy)
Time frame: Through study completion over 5 years
number of patients receiving the recommended therapy
3 secondary outcomes
Overall survival
Time frame: 5 years
Response rate
Time frame: 1 year
Progression free survival at 6 months according to RECIST criteria
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Molecular guided therapy in people with Melanoma, run by Charite University, Berlin, 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: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (actionable molecular alterations) (time frame: Through study completion over 5 years). 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 30 Sep 2021; AzTrials last refreshed its copy on 29 Oct 2026.