De Gregorio, Alex
Sacconi, Andrea
Mandoj, Chiara
Valenti, Fabio
De Pascale, Valentina
Madonna, Gabriele
Capone, Mariaelena
Meinardi, Teresa
Guerresi, Francesca
Terrenato, Irene
Cigliana, Giovanni
Russillo, Michelangelo
Ferraresi, Virginia
Fanciulli, Maurizio
Blandino, Giovanni
Ascierto, Paolo Antonio
Ciliberto, Gennaro
Mancini, Rita
Fattore, Luigi
Funding for this research was provided by:
Associazione Italiana per la Ricerca sul Cancro (IG24451)
Ministero dello Sviluppo Economico (BIOMIND)
Ministero dello Sviluppo Economico (SPID)
Ministero dell’Istruzione, dell’Università e della Ricerca (MUR-PNRR M4C2I1.3 PE6 project PE00000019)
Ministero della Salute (PNC-E3-2022-23683266)
Ministero della Salute (Ricerca Corrente 2022-2024)
Lazio Innova (A0613-2023-078139)
Article History
Received: 24 June 2025
Accepted: 27 July 2025
First Online: 13 August 2025
Declarations
:
: The study was approved by the Ethics Committees of both participating institutions: the IRCCS “G. Pascale Foundation” (Approval Numbers DSC/1504, June 11, 2014 and DSC/2893, April 11, 2015) and the IRCCS Regina Elena National Cancer Institute-IFO (Approval Number 8393, July 23, 2017), in accordance with the Declaration of Helsinki. Inclusion criteria specified patients aged ≥ 18 years with histologically confirmed, locally advanced or metastatic melanoma (Stage IIIB-IIIC or IV according to the American Joint Committee on Cancer, 7th Edition), eligible for MAPK-targeted therapy, and capable of providing informed consent. Samples from healthy donors were collected with the approval of the IRCCS Regina Elena National Cancer Institute (Rome, Italy) institutional ethics committee (Approval Number 7182, May 24, 2019). Written informed consent was obtained from all participants before inclusion in the study.
: All the authors agreed for publication of this research.
: All the authors declare no conflict of interest with the exceptions of P.A.A. P.A.A. has/had a consultant/advisory role for Bristol MyersSquibb, Roche-Genentech, Merck Sharp & Dohme, Novartis, Merck Serono, Pierre-Fabre, AstraZeneca, Sun Pharma, Sanofi, Idera, Sandoz, Immunocore, 4SC, Italfarmaco, Nektar, Boehringer-Ingelheim, Eisai, Regeneron, Daiichi Sankyo, Pfizer, Oncosec, Nouscom, Lunaphore, Seagen, iTeos, Medicenna, Bio-Al Health, ValoTX, Replimmune. He also received research funding from Bristol Myers Squibb, Roche-Genentech, Pfizer, Sanofi. Travel support by Pfizer. The funders of this study had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.