An interventional study of Molecular guided therapy in Melanoma, sponsored by Charite University, Berlin, Germany. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-30.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Basic science
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.
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.
3,006 studies on the registry are indexed under Melanoma; 519 are open to participants now.
This study's enrollment of 100 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Molecular guided therapy
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).
Feasibility (actionable molecular alterations)
number of patients with actionable molecular alterations
Time frame: Through study completion over 5 years
Feasibility (number of patients with a treatment recommendation)
number of patients with a treatment recommendation
Time frame: Through study completion over 5 years
Feasibility (number of patients receiving the recommended therapy)
number of patients receiving the recommended therapy
Time frame: Through study completion over 5 years
Overall survival
Overall survival
Time frame: 5 years
Response rate
Response rate of the patients treated according to the recommendations
Time frame: 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
Time frame: up to 6 months
No study locations are listed for this record.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany