RecruitingNCT06784778

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

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.

Sponsor

Pamgene International B.V.

Enrollment

196 participants

Start Date

Jul 12, 2024

Study Type

OBSERVATIONAL

Conditions

Melanoma Metastatic

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study is testing whether a blood test called IOpener-Melanoma can predict which patients with advanced skin cancer (melanoma) will respond to immunotherapy. Researchers are not changing your treatment — they are simply collecting data to see if the test works. **You may be eligible if...** - You are 18 or older - You have unresectable (cannot be surgically removed) Stage III or IV melanoma - You are starting first-line immunotherapy with nivolumab, pembrolizumab, or a combination of nivolumab and ipilimumab - Your expected survival is more than 3 months **You may NOT be eligible if...** - You have already had immunotherapy as a first-line treatment for advanced melanoma (within the last 6 months) - You cannot provide written informed consent - Your melanoma is not a skin (cutaneous) type Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTPBMC Kinase Activity Profile

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

Locations(3)

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany

Heidelberg University Hospital

Heidelberg, Germany

LMU Klinikum

München, Germany

View Full Details on ClinicalTrials.gov

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NCT06784778

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