Biopsy- and Biology-driven Optimization of Targeted Therapy in Subjects With Advanced Melanoma
Status:
Terminated
Trial end date:
2018-08-01
Target enrollment:
Participant gender:
Summary
This is an open-label, multi-center, clinical phase II study to explore the correlation of
the genetic make-up of the treated tumor before start of therapy and to correlate clinical
response at 8 weeks as well as metabolic response at 2 and 8 weeks with genetic features of
the tumor.
It will be conducted as a rationale optimization of targeted therapy in BRAF naïve and
pretreated patients.
Prerequisite for all patients is the availability of tumor sample at start of treatment in
order to determine the underlying driver mutation (BRAF mutational status) as well as
molecular composition by next generation sequencing (NGS) and assessable lesions for biopsy
at week 2. Melanoma patients in stage III (non-resectable) and stage IV are sorted into
Cohort A or B according to their previous BRAF-treatment and treated with dabrafenib and
trametinib (cohort A and B)