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.
Study Type
OBSERVATIONAL
Enrollment
196
Kinase activity profile will be correlated to the observed clinical outcome parameters (including survival and toxicity associated with the therapy) of standard of care treatments
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany
RECRUITINGHeidelberg University Hospital
Heidelberg, Germany
RECRUITINGLMU Klinikum
München, Germany
RECRUITING12 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.
Time frame: From the enrollment to 12 months follow up.
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.
Time frame: From enrollment to 12 months follow up.
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.
Time frame: From enrollment to 12 months follow up.
Progression Free Survival
Progression Free Survival
Time frame: From enrollment to month 24 follow up.
Overall Survival
Overall Survival
Time frame: From enrollment to month 24 follow up.
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