C43
Conditions
Interventions
Group 1: Patients with unresectable malignant melanoma stage IV who undergo a dual immuno-checkpoint blockade with nivolumab and Ipilimumab (clinical indicated).
Patients receive a FDG-PET/CT every 3
Sponsors
Universitäts-Hautklinik Tübingen
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • unresectable malignant melanoma stage IV • Age =18 years • Indicated dual immunotherapy with nivolumab and ipilimumab • PET/CT examinations for clinical indication before treatment initiation ("baseline staging") and for therapy control (3-monthly) • at least one existing measurable lesion
Exclusion criteria
Exclusion criteria: • non-consenting patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Optimizing the course of dual immunotherapy in patients with metastatic melanoma through improved therapy monitoring using liquid biopsies and PET/CT. Endpoint at completion of data collection and evaluation of data sets from 60 patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Superiority of liquid biopsies to laboratory diagnostics LDH and S100 • Definition of decision support for possible treatment breaks based on liquid biopsies and/or PE /CT (patients with SD) • Detection of recurrences during treatment breaks using liquid biopsies and/or PET/CT • Development of a prognostic index of LB, PET/CT and mutation status, which can be used to support a therapy break in SD (Endpoint at completion of data collection and evaluation of data sets from 60 patients) | — |
Countries
Germany
Contacts
Public ContactAndrea Forschner
Universitäts-Hautklinik Tübingen
Outcome results
None listed