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NCT Number: NCT06784778

Observational Study of Patients With Advanced Melanoma (Skin Cancer) to Assess if IOpener®-Melanoma Test Can Predict Response to Immunotherapy.

The goal of this observational study is to assess whether the IOpener® melanoma test can assist treating physicians in deciding which therapy is most suitable for patients with skin cancer (advanced cutaneous melanoma). For this purpose it is evaluated how well the IOpener-melanoma test can predict the result of cancer treatment in the treatment groups (standard of care anti-PD1 mono-therapy and standard of care anti-PD1 + anti-CTLA-4 therapy).

Participants will be asked to provide blood sample for analysis using IOpener®-melanoma test. Patients will receive regular medical care, the test results will not be used to make any treatment decisions. The patients will visit the clinic for treatment administration and clinical evaluation as part of their regular medical care.

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Key information

Conditions

Melanoma Metastatic Melanoma Melanoma Advanced Melanoma Stage III or IV Melanoma, Skin Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Tübingen, Tübingen, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First line treatment for unresectable stage III or IV cutaneous melanoma (according to AJCC version 8) with anti-PD1 monotherapy (nivolumab or pembrolizumab) or anti-PD1 + anti-CTL4A combination therapy (nivolumab and ipilimumab).
  • Anticipated life expectancy exceeding 3 months.
  • Aged 18 years or older and able to provide written informed consent.

Patients who have completed adjuvant treatment with anti-PD1 immunotherapy at least 6 months ago can be included.

Exclusion criteria

  • Prior treatment for irresectable stage III or stage IV melanoma with BRAF/MEK inhibitors.
  • Presence of progressive/symptomatic brain metastases at baseline.
  • WHO performance score ≥ 2.
  • Adjuvant treatment with anti-PD1 immunotherapy received within the last 6 months.
  • Patients undergoing experimental treatments or therapies.
  • Presence of any medical or other condition that in the opinion of the investigator(s) would preclude the participation in a clinical study.
  • Unwillingness or inability to comply with study and follow-up procedures.

Treatment and study plan

PBMC Kinase Activity Profile

Diagnostic Test

Kinase activity profile will be correlated to the observed clinical outcome parameters (including survival and toxicity associated with the therapy) of standard of care treatments

Other names: IOpener-melanoma

Primary outcomes

  1. 12 months Progression Free Survival rate

    Time frame: From the enrollment to 12 months follow up.

    Predictive value of IOpener-melanoma for 1-year Progression Free Survival (PFS), i.e., proportion of patients without progressive disease (PD) ≥ 1 year, stratified according to treatment group and IOpener-melanoma test result.

Secondary outcomes

  1. Disease Control Rate at 1 year

    Time frame: From enrollment to 12 months follow up.

    Disease Control Rate (DCR, "clinical benefit") at 1 year, based on Best Overall Response (BOR) according to RECIST 1.1.

  2. Overall Response Rate (ORR) at 1 year

    Time frame: From enrollment to 12 months follow up.

    Overall Response Rate (ORR) at 1 year based on Best Overall Response (BOR) according to RECIST 1.1.

  3. Progression Free Survival

    Time frame: From enrollment to month 24 follow up.

    Progression Free Survival

  4. Overall Survival

    Time frame: From enrollment to month 24 follow up.

    Overall Survival

Other outcomes

  1. Adverse events

    Time frame: From enrollment to month 24 follow up.

    Occurrence and type of adverse event or toxicity associated with standard of care.

  2. Medical costs

    Time frame: From enrollment to month 24 follow up.

    Medical costs/medical care consumption associated with adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Project Leader Clinical Trials

CONTACT

[email protected]

+ 31 (0) 73 615 80 71

Sponsors and collaborators

Lead sponsor

Pamgene International B.V.

Industry

Collaborators

  • University Hospital Tuebingen
  • lron Bridge GmbH

Registry information

Official study title

A Prospective, Observational, Multicenter Clinical Performance Study to Evaluate IOpener®-Melanoma Test for Predicting Response to Combination or Mono Immunotherapy in Stage III or IV Cutaneous Melanoma Patients.

Acronym: COMO

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 20, 2025
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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