Biopsy- and Biology-driven Optimization of Targeted Therapy in Subjects With Advanced Melanoma

Sponsor
Prof. Dr. med. Dirk Schadendorf
Study ID
NCT02410863
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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)

Key Dates

Start date
Nov 30, 2015
Status verified
Oct 2020
Primary completion
Aug 31, 2018
Completion
Aug 31, 2018

Study Design

Enrollment
10 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A (BRAFi naïve)
    Dabrafenib (BRAFi) and trametinib (MEKi) will be administered orally at their recommended doses for combination therapy of 150 mg twice daily (BID) and 2 mg daily.
  • Experimental: Cohort B (BRAFi / MEKi rechallenge)
    Dabrafenib (BRAFi) and trametinib (MEKi) will be administered orally at their recommended doses for combination therapy of 150 mg twice daily (BID) and 2 mg daily

Primary Outcome Measure

Correlation of clinical response at week 8 of targeted therapy with molecular results of the biopsies. [ Time Frame: Week 8 ]

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