Establishment and Standardization of a Platform for In-depth Tumour Profiling (TUPRO) in Patients With Melanoma

NCT06463509 | Completed

• 1 other identifier: TUPRO-Melanoma
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (9)

• Sample Processing and Report Generation (Tumor Biopsy, peripheral blood sample and stool sample)

  * 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)

  through study completion, an average of 1 year

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

  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)

  through study completion, an average of 1 year

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

  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

  through study completion, an average of 1 year

• Time to first subsequent treatment (TTFST)

  \- Time to first subsequent treatment (TTFST), incl. best supportive care

  through study completion, at least 6 month of follow up

• Time to first subsequent treatment (TTFST) ratio

  \- Time to first subsequent treatment (TTFST) ratio (TTFST 2 / TTFST 1: TTFST 2 = TTFST on current project; TTFST 1 = TTFST on previous treatment \[before entering the project\])

  through study completion, at least 6 month of follow up

• Toxicity

  \- Frequency (proportion) of patients terminating treatment due to toxicity

  through study completion, at least 6 month of follow up

• Survival

  \- Overall survival (OS), calculated from registration until death due to any cause

  through study completion, at least 6 month of follow up

• Event free survival

  \- Event free survival (EFS), defined as time to treatment failure or death

  through study completion, at least 6 month of follow up

• Radiological tumour response

  \- Proportion of patients with a radiological tumour response (CR / PR) according to local standards and trial protocol (in case of referral or trial)

  through study completion, at least 6 month of follow up

Secondary Outcomes (1)

• Quality of life

  through study completion, at least 6 month of follow up

Interventions

Establishment of an in-deepth tumor profiling platform OTHER

In-depth tumor profiling beyond genomics

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced melanoma (stage III or IV cutaneous melanoma, or rare melanoma subtypes at any stage that require systemic therapy)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reinhard Dummer: lead

Study Sites (1)

Department of Dermatology, University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

• Miglino N, Toussaint NC, Ring A, Bonilla X, Tusup M, Gosztonyi B, Mehra T, Gut G, Jacob F, Chevrier S, Lehmann KV, Casanova R, Jacobs A, Sivapatham S, Boos L, Rahimzadeh P, Schuerch M, Sobottka B, Chicherova N, Yu S, Wegmann R, Mena J, Milani ES, Goetze S, Esposito C, Sarabia Del Castillo J, Frei AL, Nowak M, Irmisch A, Kuipers J, Baciu-Dragan MA, Ferreira PF, Singer F, Bertolini A, Prummer M, Lischetti U; Tumor Profiler Consortium; Aebersold R, Bacac M, Maass G, Moch H, Weller M, Theocharides APA, Manz MG, Beerenwinkel N, Beisel C, Pelkmans L, Snijder B, Wollscheid B, Heinzelmann V, Bodenmiller B, Levesque MP, Koelzer VH, Ratsch G, Dummer R, Wicki A. Feasibility of multiomics tumor profiling for guiding treatment of melanoma. Nat Med. 2025 Jul;31(7):2430-2441. doi: 10.1038/s41591-025-03715-6. Epub 2025 May 27.

  PMID: 40425842 DERIVED

Biospecimen

Retention: NONE RETAINED

tumor tissue

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: June 17, 2024
• Study Start: January 8, 2019
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)