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MelanomaTUPRONCT06463509

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

An observational study of Melanoma, run by Reinhard Dummer at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Melanoma
What is being tested?
Establishment of an in-deepth tumor profiling platform
How many people
116 participants
Where
1 siteSwitzerland
Study dates
8 Jan 2019to 31 May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Department of Dermatology, University Hospital Zurich

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

About this study

Official title: 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.

Conditions
Melanoma
Being tested
Establishment of an in-deepth tumor profiling platform
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Establishment of an in-deepth tumor profiling platformOther

    In-depth tumor profiling beyond genomics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: through study completion, an average of 1 year

  2. 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)

    Measured: through study completion, an average of 1 year

  3. 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

    Measured: through study completion, an average of 1 year

  4. Time to first subsequent treatment (TTFST)

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

    Measured: through study completion, at least 6 month of follow up

  5. 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])

    Measured: through study completion, at least 6 month of follow up

  6. Toxicity

    • Frequency (proportion) of patients terminating treatment due to toxicity

    Measured: through study completion, at least 6 month of follow up

  7. Survival

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

    Measured: through study completion, at least 6 month of follow up

  8. Event free survival

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

    Measured: through study completion, at least 6 month of follow up

  9. 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)

    Measured: through study completion, at least 6 month of follow up

Secondary outcomes (1)

  1. 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).

    Measured: through study completion, at least 6 month of follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2024
  2. Study start8 Jan 2019
  3. Primary completion31 May 2023
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06463509
Sponsor's protocol ID
TUPRO-Melanoma
Acronym
TUPRO
Status last verified
Apr 2026
First submitted
15 May 2024
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 40425842

Questions about this trial

What is this clinical trial studying?

An observational study of Melanoma, run by Reinhard Dummer at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sample Processing and Report Generation (Tumor Biopsy, peripheral blood sample and stool sample) (time frame: through study completion, an average of 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06463509, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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