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Article History

Received: 5 March 2020

Accepted: 27 May 2020

First Online: 5 June 2020

Ethics approval and consent to participate

: Voluntary Harmonisation Procedure plus (VHP+) approval for the trial by the European competent authorities of Germany, Sweden and the Netherlands including the respective Ethic Committee in Germany was issued on: 22 January 2019 (VHP-No.: 1371 (2018131). The conduct of the trial including the patient information and consent forms were authorized by all respective competent authorities and ethics committees of Germany, Sweden, the Netherlands and Australia. The following ethics committees have approved the study:∙ Germany: Ethikkommission der Medizinischen Fakultät Heidelberg, Universität Heidelberg (AFmu-688/2018), Landesamt für Gesundheit und Soziales, Geschäftsstelle der Ethik-Kommission des Landes Berlin, Landesamt für Gesundheit und Soziales (19/0105-EK 15), Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen, Universität Duisburg-Essen (19–8630-AB), Ethik-Kommission der Medizinischen Hochschule Hannover, Medizinische Hochschule Hannover (8384_AMG_NM_2019), Ethik-Kommission an der Universität Regensburg, Universität Regensburg (19–1358-113).∙ Sweden: Regional Ethical Review Board, Stockholm, Karolinska Institute (2019–02024)∙ The Netherlands: Central Committee on Research Involving Human Subjects (CCMO) (CCMO19.0311/JvG/ML/67122, NL67122.000.19)∙ Australia: Lead Human Research Ethics Commitee (HREC), Sydney Children’s Hospitals Network Human Research Ethics Committee (2019/ETH12646)The trial is going to be submitted in Austria and France shortly. Written informed consent will be requested from all patients and/or legal representatives.

: Not applicable.

: C.v.T. reports personal fees from Novartis and personal fees from Bayer, outside the submitted work. M.P. reports non-financial support from Pfizer, non-financial support from Merck, non-financial support from Bayer, personal fees from Bayer, personal fees from Apogenix and personal fees from Affiris, outside the submitted work. In addition, M.P. has a patent “Treatment of Kynurenin-producing Tumors with AhR Antagonists” with royalties paid to Bayer, and a patent “Means and methods for treating and/or preventing natural Ahr ligand-dependent cancer” with royalties paid to Bayer. O.W. reports personal fees from Novartis and personal fees from Astra Zeneca, outside the submitted work. The other coauthors have nothing to declare.