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.
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.
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 with advanced-stage melanoma who will receive standard-of-care treatment with immune checkpoint inhibitors (ICIs).
Cohort
Prospective
PBMC Kinase Activity Profile
Diagnostic testKinase activity profile will be correlated to the observed clinical outcome parameters (including survival and toxicity associated with the therapy) of standard of care treatments
12 months Progression Free Survival rate
Predictive value of IOpener-melanoma for 1-year Progression Free Survival (PFS), i.e., proportion of patients without progressive disease (PD) ≥ 1 year, stratified according to treatment group and IOpener-melanoma test result.
Disease Control Rate at 1 year
Disease Control Rate (DCR, "clinical benefit") at 1 year, based on Best Overall Response (BOR) according to RECIST 1.1.
Overall Response Rate (ORR) at 1 year
Overall Response Rate (ORR) at 1 year based on Best Overall Response (BOR) according to RECIST 1.1.
Progression Free Survival
Progression Free Survival
Overall Survival
Overall Survival
Adverse events
Occurrence and type of adverse event or toxicity associated with standard of care.
Medical costs
Medical costs/medical care consumption associated with adverse events
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Pamgene International B.V.
Lead sponsor
University Hospital Tuebingen
Collaborator
lron Bridge GmbH
Collaborator
