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

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

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 Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Other: Establishment of an in-deepth tumor profiling platform

• Study Type: Observational
• Enrollment (Actual): 116

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8091
      • Department of Dermatology, University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	- Quality of Life using the Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7) questionnaire should be assessed during regular data collection (optional). Score range: 0-28. The higher the score, the better the Quality of life (QoL).	through study completion, at least 6 month of follow up

Collaborators and Investigators

• Sponsor: Reinhard Dummer

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2019
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma
• Other Study ID Numbers: TUPRO-Melanoma

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No