Actively Recruiting
A Prospective Observational Study to Evaluate IOpener4-Melanoma Test for Predicting Immunotherapy Response in Stage III or IV Cutaneous Melanoma
Led by Pamgene International B.V. · Updated on 2025-02-28
196
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
P
Pamgene International B.V.
Lead Sponsor
U
University Hospital Tuebingen
Collaborating Sponsor
AI-Summary
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 test's ability to predict how patients respond to immunotherapy while monitoring safety and disease progression.
CONDITIONS
Brief Title
Observational Study of Patients With Advanced Melanoma (Skin Cancer) to Assess if IOpener®-Melanoma Test Can Predict Response to Immunotherapy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with unresectable stage III or IV cutaneous melanoma
- Starting first line treatment with anti-PD1 monotherapy (nivolumab or pembrolizumab) or combination therapy (nivolumab and ipilimumab)
- Life expectancy over 3 months
- Able to provide written informed consent
- Patients who completed adjuvant anti-PD1 immunotherapy at least 6 months ago may participate
You will not qualify if you...
- Prior treatment with BRAF/MEK inhibitors for unresectable stage III or IV melanoma
- Presence of progressive or symptomatic brain metastases at baseline
- WHO performance status score of 2 or higher
- Received adjuvant anti-PD1 immunotherapy within the last 6 months
- Currently undergoing experimental treatments or therapies
- Any medical condition that would prevent participation as judged by investigators
- Unwillingness or inability to follow study and follow-up procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At enrollment
Participants undergo the IOpener®-Melanoma test and blood sample collection to evaluate kinase activity profiles correlated with their clinical outcomes under standard of care treatments.
1 visit (in-person)
Duration - Up to 24 months
Participants are monitored while receiving standard of care immunotherapy to assess disease progression, response to treatment, and survival outcomes.
Regular follow-up visits as part of routine care
Trial Site Locations
Total: 3 locations
1
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany, 72016
Actively Recruiting
2
Heidelberg University Hospital
Heidelberg, Germany, 69120
Actively Recruiting
3
LMU Klinikum
München, Germany, 80337
Actively Recruiting
Research Team
P
Project Leader Clinical Trials
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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