Establishment and Standardization of a Platform for In-depth Tumour Profiling (TUPRO) in Patients With Advanced Melanoma - a Prospective, Multicentric HFV Research Project/Category A

Reinhard Dummer2 sites in 1 country116 target enrollmentStarted: January 8, 2019Last updated: May 1, 2026

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor
Enrollment: 116
Locations: 2
Primary Endpoint: Sample Processing and Report Generation

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

TUPRO-Melanoma is the first project of the Tumour Profiler (TUPRO) research collaboration, which in the long-term aims to generate data that will help to understand and report the individual tumour biology and the clinical parameters for patients with advanced malignancies using innovative molecular technologies and computational analyses for in-depth molecular profiling. TUPRO-Melanoma is an exploratory project that aims to establish a comprehensive platform for in-depth tumour profiling in patients suffering from advanced melanoma. Aims of this platform are to establish logistics and algorithms for integrative analyses and discover new molecular biomarker profiles/patterns.

Study Design

Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective

Eligibility Criteria

Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•Age ≥ 18 years
•ECOG performance status ≤2 (not bedridden for more than 50% of waking hours)
•Stage III or IV cutaneous melanoma, or rare melanoma subtypes at any stage that require systemic therapy
•Written informed consent according to national legal and regulatory requirements prior to any project specific procedures

Exclusion Criteria

•Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the sponsor-project leader or site project leader may interfere with the project or affect patient compliance
•Legal incompetence

Outcomes

Primary Outcomes

Sample Processing and Report Generation

Time Frame: through study completion, an average of 1 year

* Number of samples (with sufficient material and quality) made available for intended analysis per technology * Number of molecular summary reports (generated from the translational domain) that could be made available to the Tumour Board * Number (proportion) of cases in which the Tumour Board considers the molecular summary report as useful for making a treatment recommendation on a scale from zero (not useful at all) to five (very useful). * Number (proportion) of cases in which the treating physician considers the Tumour Board's recommendation as useful for making a treatment decision on a scale from zero (not useful at all) to five (very useful) * Types of molecular information and combinations of molecular information from the biotechnology domain that the pre-Tumour Board considers as useful for making a treatment recommendation beyond routine diagnostics (incl. routine pathology and NGS testing)

Classification of proposed treatment options (according to the one of the 7 categories below)

Time Frame: through study completion, an average of 1 year

Select one of the following categories: * On-label treatment with molecular matched treatment (SwissMedic label as reference) +/- radiotherapy or chemotherapy; * Treatment with classical chemotherapy +/- radiotherapy (on label if label available); * Referral to a suitable clinical trial; * Off-label treatment (SwissMedic label as reference) with molecular matched treatment or immunotherapy +/- radiotherapy or chemotherapy; * Off-label treatment (authorization in countries with comparable control systems for medicinal products as defined by SwissMedic) with molecular matched treatment or immunotherapy +/- radiotherapy or chemotherapy; * Immunotherapy * No active anti-tumour treatment (best supportive care)

Classification of Tumour Board's recommendations according to ESCAT (categories below)

Time Frame: through study completion, an average of 1 year

Select one of the categories below: * I-A: prospective, randomised clinical trials show the alteration-drug match in a specific tumour type results in a clinically meaningful improvement of a survival end point * II-A: retrospective studies show patients with the specific alteration in a specific tumour type experience clinically meaningful benefit with matched drug com pared with alteration-negative patients * III-A: clinical benefit demonstrated in patients with the specific alteration (as tiers I and II above) but in a different tumour type. Limited/absence of clinical evidence available for the patient-specific cancer type or broadly across cancer types * IV-A: evidence that the alteration or a functionally similar alteration influences drug sensitivity in preclinical in vitro or in vivo models * X: No evidence that the genomic alteration is therapeutically actionable

Time to first subsequent treatment (TTFST)