Assessing a test to predict treatment response in advanced melanoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of the IOpener® melanoma test in predicting treatment responses for patients with advanced cutaneous melanoma. Participants will provide blood samples for analysis while receiving standard medical care, including anti-PD1 monotherapy or combination therapy. The results of the IOpener test will not influence treatment decisions but will help in understanding its predictive capabilities. The study focuses on patients with unresectable stage III or IV melanoma who are starting first-line treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Universitätsklinikum Tübingen
  Tübingen, Baden-Wurttemberg, Germany Recruiting
• Heidelberg University Hospital
  Heidelberg, Germany Recruiting
• LMU Klinikum
  München, Germany Recruiting

Study contacts

• Study coordinator: Project Leader Clinical Trials
• Email: dvdheuvel@pamgene.com
• Phone: + 31 (0) 73 615 80 71

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.