"Dabrafenib and Trametinib in Circulating Free DNA BRAFV600 Mutated Metastatic Melanoma Patients: a Prospective Phase II, Open Label, Multicentre Study - (Bioliquid TAILOR Study - BIOTAILOR)"

Summary

There is evidence from cohort studies and metanalysis that a shift from BRAFWT to BRAF mutated melanomas can occur (Colombino JCO 2012, Valchis EJC 2017). Based on previous studies we expect that 15% of tissue BRAF WT patients treated with anti PD-1 will become circulating free DNA BRAF (CfDNA BRAF) mutation-positive and, at progression, they will be elegible to be treated with dabrafenib/trametinib. We aimed to design a clinical phase II trial in order to evaluate the activity of Dabrafenib and Trametinib in patients with Tissue BRAFWT signature and a molecular shift to circulating free DNA BRAF mutated positive melanomas upon progression to anti PD-1 therapy.

Timeline

Start

2021-02-18

Primary completion

2023-03-30

Completion

2023-03-30

Drugs

Indications