Metastatic Melanoma Patients Under Immunotherapy: Monitoring of Therapeutic Success Using Liquid Biopsy and PET/CT in a Prospective Study

Not Applicable

• Conditions: C43; Malignant melanoma of skin

• Registration Number: DRKS00017724
• Lead Sponsor: niversitäts-Hautklinik Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-01
• Study Completion: 2021-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

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

• non-consenting patients

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
• Superiority of liquid biopsies to laboratory diagnostics LDH and S100<br>• Definition of decision support for possible treatment breaks based on liquid biopsies and/or PE /CT (patients with SD)<br>• Detection of recurrences during treatment breaks using liquid biopsies and/or PET/CT<br>• Development of a prognostic index of LB, PET/CT and mutation status, which can be used to support a therapy break in SD<br>(Endpoint at completion of data collection and evaluation of data sets from 60 patients)