Observational Study to Evaluate IOpener-Melanoma Test Predicting Response to Immunotherapy in Advanced Stage III or IV Skin Melanoma

What this Trial Is About

Researchers are evaluating how well the IOpener4 melanoma test can help doctors predict the best treatment for patients with advanced cutaneous melanoma skin cancer in stages III or IV. This observational study focuses on patients receiving standard immunotherapy treatments, including anti-PD1 mono-therapy and a combination of anti-PD1 and anti-CTLA-4 therapy. The study aims to understand if the test can forecast patients responses to these treatments over time. Participants will provide blood samples to analyze kinase activity profiles using the IOpener4 melanoma test. The test results will not influence treatment decisions, as patients will continue receiving their regular care with either nivolumab or pembrolizumab alone, or a combination of ipilimumab and nivolumab. The study observes and compares outcomes from these two treatment groups without altering standard care. During the study, participants will have regular medical visits for treatment and clinical evaluations as part of their usual care. Researchers will track key outcomes, including progression-free survival at 12 months, disease control rate, overall response rate, and overall survival up to 24 months after enrollment. These measurements will help assess the tests ability to predict how patients respond to immunotherapy while monitoring safety and disease progression.

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