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Brief Title: "Dabrafenib and Trametinib in Circulating Free DNA BRAFV600 Mutated Metastatic Melanoma Patients: a Prospective Phase II, Open Label, Multicentre Study - (Bioliquid TAILOR Study - BIOTAILOR)"
Official Title: "Dabrafenib and Trametinib in Circulating Free DNA BRAFV600 Mutated Metastatic Melanoma Patients: a Prospective Phase II, Open Label, Multicentre Study - (Bioliquid TAILOR Study - BIOTAILOR)"
Study ID: NCT05299580
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
IRCCS - Istituto Scientifico Romagnolo per la Cura e lo Studio dei Tumori (I.R.S.T) S.r.l., Meldola, Forlì-Cesena, Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo, Alessandria, , Italy
National Institute of Cancer, Bari, , Italy
Università degli Studi di Bari Aldo Moro, Bari, , Italy
AOU Sant'Orsola-Malpighi, Bologna, , Italy
ASST Spedali Civili Brescia, Brescia, , Italy
Azienda Sanitaria Ospedaliera S. Croce e Carle, Cuneo, , Italy
IRCCS San Martino - IST, Genova, , Italy
Fondazione I.R.C.C.S. Istituto Nazionale dei Tumori, Milano, , Italy
Azienda Ospedaliera Universitaria di Modena, Modena, , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale", Naples, , Italy
Istituto Oncologico Veneto, Padova, , Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, , Italy
Istituto Nazionale Tumori Regina Elena, Roma, , Italy
Azienda Ospedaliera Universitaria - Città della Salute e della Scienza di Torino, Torino, , Italy
Azienda Ospedaliera Universitaria Integrata di Udine, Udine, , Italy