Neoadjuvant plus adjuvant combined or sequenced vemurafenib, cobimetinib and atezolizumab in patients with high-risk, resectable BRAF-mutated and wild-type melanoma: NEO-TIM, a phase II randomized non-comparative study.

Background

Following the increased survival of patients with metastatic melanoma thanks to immunotherapy and targeted therapy, neoadjuvant approaches are being investigated to address the unmet needs of unresponsive and intolerant patients. We aim to investigate the efficacy of neoadjuvant plus adjuvant combined or sequenced vemurafenib, cobimetinib and atezolizumab in patients with high-risk, resectable

Methods

The study is a phase II, open-label, randomized non-comparative trial in patients with stage IIIB/C/D surgically resectable,

Discussion

Neoadjuvant therapy for regional metastases may improve operability and outcomes and facilitate the identification of biomarkers that can guide further lines of treatment. Patients with clinical stage III melanoma may especially benefit from neoadjuvant treatment, as the outcomes of surgery alone are very poor. It is expected that the combination of neoadjuvant and adjuvant treatment may reduce the incidence of relapse and improve survival.

Clinical trial registration

eudract.ema.europa.eu/protocol.htm, identifier 2018-004841-17.

Informations de copyright

Copyright © 2023 Ascierto, Cioli, Chiarion-Sileni, Quaglino, Spagnolo, Guidoboni, Del Vecchio, Peris, Queirolo, Fioretto, Caracò, Paone, Sorrentino, Capone, Giannarelli, Ferrara, Massi and Trojaniello.

Déclaration de conflit d'intérêts

PA has/had a consultant/advisory role for Bristol Myers Squibb, 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; Vanna Chiaron Sileni: Travel support for medical congress for Bristol Myers-Squibb, lectures fees and Advisory Board for Merck Sharp & Dohme, participation to advisory board for Novartis, Pierre Fabre; PiQ: speaker fees e advisory boards for BMS, MSD, Pierre-Fabre, Novartis, Roche; FS: Honoraria: BMS, Roche, Novartis, MSD, Sanofi, Merck, Sunpharma, Pierre-Fabre. Advisory Board: MSD, Novartis, Sunphama, Pierre Fabre; Massimo Guidoboni Consulting or Advisory Role: BMS, Novartis, Pierre Fabre Speakers’ Bureau: BMS, Novartis, Pierre Fabre Research Funding; MV: reports research finding to their institution for clinical studies from MSD and honoraria as consultant or advisor for Novartis, Bristol Myers Squibb, MSD, and Pierre Fabre; KP reports advisory board roles with Abbvie, LEO Pharma, Janssen, Almirall, Eli Lilly, Galderma, Novartis, Pierre Fabre, Sun Pharma, and Sanofi; PaQ: advisory and consultant role for Roche, BMS, Merck, MSD, Novartis, Pierre Fabre, Sun Pharma, Sanofi; DM has received honoraria for professional services and consultancy for Novartis, Bayer HealthCare Pharmaceuticals Inc., Pierre-Fabre, Sanofi Genzyme, MSD Italia S.r.l., Roche, Skyline Dx B.V, Diatech Pharmacogenetics. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.