Clinical trial NCT05063058: Biomarker-driven Therapy for Melanoma
Official title: Feasibility Study of Biomarker-driven Therapy Based on a Comprehensive Molecular Analysis of Tumor Tissue and Blood Collections in Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Max-Planck Institut
name: Alacris
First posted: 2021-09-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- history of cardiac disease or metastatic brain or meningeal tumors

Primary outcomes:
measure: Feasibility (actionable molecular alterations)
timeFrame: Through study completion over 5 years
measure: Feasibility (number of patients with a treatment recommendation)
timeFrame: Through study completion over 5 years
measure: Feasibility (number of patients receiving the recommended therapy)
timeFrame: Through study completion over 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: Response rate
timeFrame: 1 year
measure: Progression free survival at 6 months according to RECIST criteria
timeFrame: up to 6 months
Other outcomes:
Locations:
Study officials:
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