Assessing a test to predict treatment response in advanced melanoma patients

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.

This study tests if the IOpener® melanoma test can help predict how well treatment will work for people with advanced melanoma who are starting their first-line therapy.

Quick facts

• Study type: Observational
• Enrollment: 196 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Pamgene International B.V. (industry)
• Drugs / interventions: nivolumab, pembrolizumab, ipilimumab, immunotherapy
• Locations: 3 sites (Tübingen, Baden-Wurttemberg and 2 other locations)
• Trial ID: NCT06784778 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with unresectable stage III or IV cutaneous melanoma who are starting first-line immunotherapy.

Not a fit: Patients who have received prior treatment with BRAF/MEK inhibitors or those with symptomatic brain metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify the most effective treatment options for patients with advanced melanoma, potentially improving their outcomes.

How similar studies have performed: Other studies have shown promise in using similar predictive tests for immunotherapy responses, suggesting potential for success in this approach.

Eligibility criteria

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 this trial is running

Tübingen, Baden-Wurttemberg and 2 other locations

• 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

Conditions: Melanoma Metastatic, Melanoma, Skin, Melanoma Stage III or IV, Melanoma Advanced, melanoma, IOpener, immunotherapy, immune checkpoint inhibitor