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Article History

Received: 2 August 2022

Accepted: 27 October 2022

First Online: 17 November 2022

Declarations

:

: The NIBIT-M4 Phase Ib trial was conducted in accordance with the ethical principles of the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice. The protocol was approved by the independent ethics committee of the University Hospital of Siena (Siena, Italy). All participating patients (or their legal representatives) provided signed-informed consent before enrolment. The trial was registered with European Union Drug Regulating Authorities ClinicalTrials EudraCT, number 2015–001329-17, and with , number NCT02608437.

: Not applicable.

: AA received compensated educational activities from the Bristol-Myers Squibb. AMDG served as a consultant and/or advisor to Incyte, Pierre Fabre, Glaxo Smith Kline, Bristol-Myers Squibb, Merck Sharp Dohme, and Sanofi and has received compensation for educational activities from Bristol Myers Squibb, Merck Sharp Dohme, Pierre Fabre and Sanofi. MM has served as a consultant and/or advisor to Roche, Bristol-Myers Squibb, Merck Sharp Dohme, Incyte, AstraZeneca, Amgen, Pierre Fabre, Eli Lilly, Glaxo Smith Kline, Sciclone, Sanofi, Alfasigma, and Merck Serono, and owns shares in Epigen Therapeutics. SC and AC own shares in Epigen Therapeutics. G. Palmieri has an advisory role in Bristol-Myers Squibb, Merck Sharp Dohme, Roche, Novartis, Pierre-Fabre and Incyte. A. Maurichi received compensation for educational activities from Novartis. G. Pruneri has received honoraria from from AstraZeneca, Novartis, Exact Sciences, Roche and Illumina and is an advisory board member of ADS Biotec. A. Molla, GN, VEP, FS, CF, MFL, A. Manca, MCS, MP, SB, TN,FC, MS and RM declare no conflict of interest.