Cicin, Irfan http://orcid.org/0000-0002-7584-3868
Plimack, Elizabeth R.
Gurney, Howard
Leibowitz, Raya
Alekseev, Boris Y.
Parnis, Francis X.
Peer, Avivit
Necchi, Andrea
Bellmunt, Joaquim
Nishiyama, Hiroyuki
Clark, Jason
Munteanu, Mihaela
Kataria, Ritesh
Jia, Calvin
Powles, Thomas
Sternberg, Cora N.
Funding for this research was provided by:
Merck Sharp & Dohme Corp.
Incyte Corporation
Article History
Received: 19 August 2022
Accepted: 21 July 2023
First Online: 25 July 2024
Declarations
:
: The study was approved by the ethics committees at each institution (Bellberry Human Research Ethics Committee; CEIC de la Comunidad Foral de Navarra; Chaim Sheba Medical Center Tel Hashomer Helsinki Committee; Chang Gung Medical Foundation Institutional Review Board; Clinical Research Ethics Committee of the Cork Teaching Hospitals; Comitato Etico Della Fondazione IRCCS Fondazione IRCCS Istituto Nazionale dei Tumori; Comite d ethique de la recherche du CHU de Quebec Universite Laval; Comité de Protection des Personnes Est 3; De Videnskabsetiske Komiteer For Region Hovedstaden; Fox Chase Cancer Center IRB; Institutional Review Board, National Cheng Kung University Hospital; Institutional Review Board of Osaka International Cancer Institute; Ivanovo Regional Oncology Dispensary; Leningrad Regional Oncology Center; Macquarie University Human Research Ethics Committee. Medical Sciences; Meir Hospital IRB-Committee; N.N. Blokhin NMRCO IRB/IEC; Nagoya University Hospital Institutional Review Board; National Medical Research Radiological Centre; NSLHD Human Research Ethics Committee; Rabin Medical Center IRB-Committee; Rambam—MC – ERC; Samsung Medical Center IRB/IEC; Seoul National University Hospital, IRB Biomedical Research Institute; Soroka M.C IRB; T.C. Trakya Üniversitesi Edirne Klinik Araştırmalar Etik Kurulu; Taipei Veterans General Hospital Institutional Review Board 2). All patients provided written informed consent.
: Not applicable.
: IC is an advisory board member for AstraZeneca, Boehringer Ingelheim, Eli Lilly, F. Hoffmann-La Roche, MSD, and Pfizer; received personal fees for lectures from Eli Lilly, MSD, Novartis, Pfizer, Quintiles, and Roche; received funding to the institution to support trial conduct from Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Eli Lilly, Merck Serono, MSD, Parexel, Pfizer, Quintiles, and Taiho. ERP reports grants from the Sponsor of trial described in this publication, during the conduct of the study; grants and personal fees from Genentech, AstraZeneca, Bristol-Myers Squibb, Merck, and Pfizer; grants from Peloton and Astellas; personal fees from Incyte, Seattle Genetics, Janssen, Flatiron Health, Infinity Pharma, and MEI Pharma; in addition, ERP has a patent, U.S. Patent Application No. 14/588,503, pending; and has received honoraria for CME certified presentations from the following entities: AUA, Clinical Care Options, Fox Chase Cancer Center, Georgetown, ASCO, Medscape, Mt Sinai Icahn School of Medicine, NCCN, Omniprex, OncLive, PER, PriME Oncology, Research to Practice, Spire Learning, University of Pennsylvania, Thomas Jefferson University, and the University of Michigan. HG received honoraria from Pfizer; served in a consulting or advisory role for Pfizer, Ipsen, Bristol-Myers Squibb, AstraZeneca, Janssen-Cilag, Merck Sharp & Dohme, and Roche; and has received support for travel/accommodations from AstraZeneca. RL has served in a consulting/advisory role for Pfizer, Bristol-Myers Squibb, MSD, Roche, Isotopia, AstraZeneca, Bayer, Astellas, and Janssen. BYA received personal fees for consulting, advisory boards, and lectures as well as personal grants and institutional grants for trials from: Astrazeneca, Astellas, Bayer, BMS, Eisai, Ferring, Janssen, Ipsen, Merck, MSD, Pfizer, Roche, and Sanofi. FXP is an advisory board member for Bayer and Janssen. AP has served in an advisory role for AstraZeneca, Bristol-Myers Squibb, Roche, MSD/Merck & Co., Janssen, Pfizer, Teva, Astellas, Bayer, and Eisai. AN reports honoraria from Roche, Merck, AstraZeneca, Janssen, BMS, and Foundation Medicine; a consulting or advisor role with Merck, Roche, Bayer, AstraZeneca, Clovis Oncology, Janssen, Incyte, Seattle Genetics/Astellas, Bristol-Myers Squibb, Rainier Therapeutics, Glaxo Smith Kline, and Ferring; research funding to the institution from Merck, Astra Zeneca, and Ipsen; support for travel/accommodation/expenses from Roche, Merck, AstraZeneca, Janssen, and Rainier Therapeutics; and spousal employment/stock ownership with Bayer. JB reports consultancy and lectures fee from: Merck, AstraZeneca, Genentech, Pfizer, and BMS. HN is an advisory board member for AstraZeneca, MSD, Ono, Bristol-Myers Squibb, Chugai, Taiho, and Janssen; received personal fees for lectures from MSD, Chugai, Ono, AstraZeneca, and Astellas; and received funding to the institution to support trial conduct from Ono and Chugai. JC and MM are salaried employees of and own stock in Incyte Corporation. RK and CJ are salaried employees of and own stock in Merck & Co., Inc., Rahway, NJ, USA. TP reports advisory and lecture fees from AstraZeneca, BMS, Exelixis, Incyte, Ipsen, Merck, MSD, Novartis, Pfizer, Seattle Genetics, Merck Serono, Astellas, Johnson & Johnson, Eisai, and Roche; grant/funding to Institution from: AstraZeneca, Roche, BMS, Exelixis, Ipsen, Merck, MSD, Novartis, Pfizer, Seattle Genetics, Merck Serono, Astellas, Johnson & Johnson, and Eisai; and travel/accommodation/expenses from Roche, Pfizer, MSD, AstraZeneca, and Ipsen. CNS has served as a consultant for Pfizer, Merck, MSD, AstraZeneca, Astellas Pharma, Sanofi-Genzyme, Roche/Genentech, Incyte, Medscape, Immunomedics, Clovis Oncology, and UroToday.