Knödler, Maren
Körfer, Justus
Kunzmann, Volker
Trojan, Jörg
Daum, Severin
Schenk, Michael
Kullmann, Frank
Schroll, Sebastian
Behringer, Dirk
Stahl, Michael
Al-Batran, Salah-Eddin
Hacker, Ulrich
Ibach, Stefan
Lindhofer, Horst
Lordick, Florian
Article History
Received: 8 March 2018
Revised: 12 May 2018
Accepted: 21 May 2018
First Online: 10 July 2018
Competing interests
: F.L. has received consulting fees from Astellas, BioNTech, Bristol-Myers-Squibb, Eli Lilly, Ganymed Pharmaceuticals, Merck Sharp & Dohme; lecture honoraria from Amgen, Astra Zeneca, Eli Lilly, Merck Sharp & Dohme, Servier and research support from Fresenius Biotech. V.K. has received research support from Fresenius Biotech. S.I. has received consulting fees from AIO gGmbH. SEAB has an advisory role with Merck, Roche, Celgene, Lilly, and Nordic Pharma; S.I. is a speaker for Merck, Roche, Celgene, Lilly, and Nordic Pharma; and has received research grants from Sanofi, Merck, Roche, Celgene, Vifor, Medac, Hospira, and Lilly. H.L. is the CEO of Trion Research and inventor or coinventor of several trifunctional antibody patents. All other authors declare no competing interest.
: All patients provided written informed consent. Approvals for the study protocol and amendments were obtained from independent ethics committees. The study was conducted in Germany according to the Good Clinical Practice Guidelines and the latest version of the Declaration of Helsinki.
: This manuscript does not contain any individual person’s data in any form.
: The sponsor (AIO) was responsible for data management and statistical analysis and was supported by a contracted clinical research organisation (WiSP GmbH, Langenfeld). The first authors and the senior author had full access to all study data and MK and FL had the final responsibility for the decision to submit for publication.
: This work was supported by the Arbeitsgemeinschaft Internistische Onkologie gGmbH (AIO) as a legal sponsor of the trial (no grant numbers apply). The work was also supported by an unrestricted grant and drug supply (catumaxomab) by Fresenius Biotech (no grant numbers apply).
: This work is published under the standard license to publish agreement. After 12 months the work will become freely available and the license terms will switch to a Creative Commons Attribution 4.0 International (CC BY 4.0).