Actively Recruiting
Observational Study of Patients With Advanced Melanoma (Skin Cancer) to Assess if IOpener®-Melanoma Test Can Predict Response to Immunotherapy.
Led by Pamgene International B.V. · Updated on 2025-02-28
196
Participants Needed
3
Research Sites
154 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
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.
CONDITIONS
Official 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...
- First line treatment for unresectable stage III or IV cutaneous melanoma with anti-PD1 monotherapy (nivolumab or pembrolizumab) or anti-PD1 + anti-CTLA-4 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
You will not qualify if you...
- Prior treatment for unresectable stage III or IV melanoma with BRAF/MEK inhibitors
- Presence of progressive or symptomatic brain metastases at baseline
- WHO performance score 2 or higher
- Adjuvant treatment with anti-PD1 immunotherapy received within the last 6 months
- Patients undergoing experimental treatments or therapies
- Any medical or other condition that would prevent participation in the study according to the investigator's opinion
- Unwillingness or inability to comply with study and follow-up procedures
AI-Screening
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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
CONTACT
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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