Weide, Benjamin http://orcid.org/0000-0002-7941-223X
Eigentler, Thomas http://orcid.org/0000-0003-0019-2770
Catania, Chiara http://orcid.org/0000-0001-6767-1958
Ascierto, Paolo Antonio http://orcid.org/0000-0002-8322-475X
Cascinu, Stefano http://orcid.org/0000-0003-2215-0731
Becker, Jürgen C. http://orcid.org/0000-0001-9183-653X
Hauschild, Axel http://orcid.org/0000-0002-1212-9587
Romanini, Antonella http://orcid.org/0000-0002-3323-1898
Danielli, Riccardo
Dummer, Reinhard http://orcid.org/0000-0002-2279-6906
Trefzer, Uwe
Elia, Giuliano http://orcid.org/0000-0001-8216-9560
Neri, Dario http://orcid.org/0000-0001-5234-7370
Garbe, Claus http://orcid.org/0000-0001-8530-780X
Funding for this research was provided by:
Philogen S.p.A.
Article History
Received: 18 April 2019
Accepted: 22 August 2019
First Online: 3 September 2019
Compliance with ethical standards
:
: Benjamin Weide has received speaker or advisory board honoraria from Amgen, CureVac, Philogen, Novartis as well as research funding from Bristol-Myers Squibb (BMS), Merck, Sharp & Dohme (MSD) and Philogen. Paolo Ascierto reports grants and personal fees from BMS, grants and personal fees from Roche-Genentech, personal fees from MSD, grants and personal fees from Array, personal fees from Novartis, personal fees from Merck Serono, personal fees from Pierre Fabre, personal fees from Incyte, personal fees from Genmab, personal fees from NewLink Genetics, personal fees from Medimmune, personal fees from AstraZeneca, personal fees from Syndax, personal fees from Sun Pharma, personal fees from Sanofi, personal fees from Idera, personal fees from Ultimovacs, personal fees from Sandoz, personal fees from Immunocore, personal fees from 4SC, outside the submitted work; Jürgen C. Becker has received speaker honoraria from Amgen, Merck Serono, and Pfizer, advisory board honoraria from Amgen, CureVac, eTheRNA, Lytix, Merck Serono, Novartis, Rigontec, and Takeda as well as research funding from Alcedis, Boehringer Ingelheim, BMS and Merck Serono; he also received travel support from 4SC and Incyte; Axel Hauschild received clinical trial support, speaker´s honoraria, or consultancy fees from the following companies: Amgen, BMS, Merck Serono, MSD, Novartis, Philogen, Pierre Fabre, Provectus, Regeneron, Roche, OncoSec, Sanofi-Genzyme, and Sun Pharma; Reinhard Dummer reports intermittent, project focused consulting and/or advisory relationships with Novartis, MSD, BMS, Roche, Amgen, Takeda, Pierre Fabre, Sun Pharma, Sanofi, Catalym, Second Genome outside the submitted work; Giuliano Elia is an employee of Philochem AG, a company of the Philogen group; Dario Neri is shareholder and Board Member of Philogen S.p.A.; Claus Garbe reports personal fees from Philogen, during the conduct of the study; personal fees from Amgen, personal fees from MSD, grants and personal fees from Novartis, personal fees from NeraCare, grants and personal fees from BMS, personal fees from Philogen, grants and personal fees from Roche, grants and personal fees from Sanofi, outside the submitted work. All other authors declare no conflict of interest.
: The protocol was approved by the regulatory authorities Paul-Ehrlich-Institut in Germany (authorization no. 593/01 of 01/07/2008), ISS in Italy (authorization of 21/02/2008), Swissmedic in Switzerland (authorization no. 2011DR2225 of 30/12/2011) and BASG in Austria (authorizations nos. 717349/0001 and 717350/0001 of 06/04/2011). The study was also approved by the ethics committee of the coordinating center for the 3 participating centers in Germany (Ethikkommission an der Medizinischen Fakultät der Eberhard-Karls-Universitäts und am Universitätsklinikum Tübingen, Tübingen, Germany—approval number: 33/2008AMG1 of 01/09/2010 for Tübingen; and of 25/01/2011 for Kiel and Berlin); by the central ethic committee at IEO in Milan, Italy (authorization no. R363-IEO S387/607 of 21/02/2008) and four local ethics committees for the other four participating centers in Italy (Ancona, approval number 210520 of 02/12/2010; Naples, approval number CEI/538/10 of 25/11/2010; Pisa, approval number 2497/2008 of 01/12/2010; and Siena, approval number 82/2009 of 21/10/2010); by the local ethics committee for the participating center in Switzerland (Kantonale Ethikkommission Zürich (KEK), Zürich, Switzerland—approval number: KEK-ZH-Nr. 2011-0362 of 15/11/2011); and by the local ethics committee for the participating center in Austria (Ethikkommission Medizinischer Universitäts Graz, Graz, Austria—approval number 23-176 ex 10/11 of 06/04/2011). The study was conducted in accordance with Good Clinical Practice guidelines (EudraCT No.: 2007-005737-11; ClinicalTrials.gov Identifier: NCT01055522). All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
: Informed consent on being treated as well as on the use of generated data for research purposes and publication was obtained from all individual participants included in the study.