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Article History

Received: 11 December 2020

Accepted: 29 January 2021

First Online: 15 February 2021

Ethics approval and consent to participate

: The trial was conducted in accordance with the Declaration of Helsinki and the International Council for Harmonisation Guideline for Good Clinical Practice. The protocol was approved by the institutional review board or independent ethics committee of each center, and all patients provided written informed consent before entering the EAP.

: All patients provided consent for their data to be reported.

: G. Grignani has received honoraria from and provided a consulting or advisory role for Bayer, Eisai, Novartis, Pfizer, and PharmaMar; received research funding and reimbursement for travel and accommodation expenses from PharmaMar; and received reimbursement for travel and accommodation expenses from Tesaro. V. Chiarion Sileni has provided a consulting or advisory role and speaker services for Bristol Myers Squibb, EMD Serono (an affiliate of Merck KGaA, Darmstadt, Germany), Merck & Co., Novartis, and Pierre Fabre; provided a consulting or advisory role for Roche; and received reimbursement for travel and accommodation expenses from Bristol Myers Squibb and Pierre Fabre. C. Pinto has received honoraria from and provided a consulting or advisory role for Amgen, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Janssen, Incyte, Merck & Co., Merck KGaA, Novartis, Roche, and Sanofi; and received research funding from Bayer, Bristol Myers Squibb, Daiichi Sankyo, and Eli Lilly. N. Fazio has received honoraria from Advanced Accelerator Applications, Ipsen, Merck KGaA, Novartis, and Sanofi; provided a consulting or advisory role for Advanced Accelerator Applications, EMD Serono, Ipsen, Merck & Co., Novartis/Ipsen, Pfizer, and Wren Laboratories; received research funding from EMD Serono, Ipsen, Merck & Co., and Novartis; and reports other relationship with Il Pensiero Scientifico Editore and Springer. P. Queirolo has provided a consulting or advisory role for Bristol Myers Squibb, Merck & Co., Novartis, Pierre Favre, Roche/Genentech, and Sanofi. E. Benincasa is an employee of Merck KGaA, Darmstadt, Germany. F. Venturini and G. Fazzi are employees of Merck Serono SpA; an affiliate of Merck KGaA, Darmstadt, Germany. N. Costa is an employee of Pfizer. P. A. Ascierto has provided a consulting or advisory role for 4SC, Alkermes, Amgen, Array BioPharma, AstraZeneca, Bristol Myers Squibb, EMD Serono, Genmab, Idera, Immunocore, Incyte, Italfarmaco, Medimmune, Merck & Co, Nektar, NewLink Genetics, Novartis, Pierre Fabre, Roche/Genentech, Sandoz, Sanofi, Sun Pharma, Syndax, and Ultimovacs; received research funding from Array BioPharma, Bristol Myers Squibb, and Roche/Genentech; received reimbursement for travel and accommodation expenses from Merck & Co; and owns stock in PrimeVax. All remaining authors have no competing interests.