Felip, Enriqueta
Moreno, Victor
Morgensztern, Daniel
Curigliano, Giuseppe
Rutkowski, Piotr
Trigo, José Manuel
Calvo, Aitana
Kowalski, Dariusz
Cortinovis, Diego
Plummer, Ruth
Maio, Michele
Ascierto, Paolo A.
Vladimirov, Vladimir I.
Cervantes, Andres
Zudaire, Enrique
Hazra, Anasuya
T’jollyn, Huybrecht
Bandyopadhyay, Nibedita
Greger, James G.
Attiyeh, Edward
Xie, Hong
Calvo, Emiliano http://orcid.org/0000-0003-4921-829X
Funding for this research was provided by:
Janssen Research and Development
Article History
Received: 21 September 2021
Accepted: 16 February 2022
First Online: 17 March 2022
Declarations
:
: Enriqueta Felip declares advisory board participation for AbbVie, Amgen, AstraZeneca, Bayer, Beigene, Blue Print Medicines, Boehringer Ingelheim, BMS, Lilly, GSK, Janssen, Medical Trends, Merck KGaA, Merck Sharp and Dohme, Novartis, Peptomyc, Pfizer, Puma Biotechnology, Regeneron, Roche, Sanofi Genzyme, Syneos Health, Takeda, Grifols; speaker bureau participation for AstraZeneca, Boehringer Ingelheim, BMS, Lilly, Merck Sharp and Dohme, Novartis, Peervoice, Pfizer, prIME Oncology, Roche, Takeda, Touchmedical, CME Outfitters; research funding from Fundación Merck Salud and a grant for oncology innovation; and is an Independent Member of the Board at Grifols. Victor Moreno declares consulting fees from Basilea, Bayer, BMS, Roche, and Janssen; and honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Bayer, BMS, and Janssen. Daniel Morgensztern declares consulting fees from AbbVie, Gilead, G1 Therapeutics, Lilly, PharmaMar, and Takeda; and participation on a data safety monitoring board or advisory board for BMS. Giuseppe Curigliano declares personal fees from Astra Zeneca, BMS, Boehringer Ingelheim, Daiichi Sankyo, Foundation Medicine, GSK, Lilly, Novartis, Pfizer, Roche, Samsung, and Seagen; non-financial support from Pfizer and Roche; grants from Merck; and other conflicts of interest/competing interests outside the submitted work from Ellipsis. Piotr Rutkowski declares payment or honoraria from BMS, Merck, MSD, Novartis, Pierre Fabre, and Sanofi; and participation on a data safety monitoring board or advisory board for Blueprint Medicines, BMS, Merck, MSD, Philogen, Pierre Fabre, and Sanofi. Diego Cortinovis declares speaker bureau participation for AstraZeneca, BMS, Boehringer Ingelheim, and MSD; and consultancy fees for Amgen, Novartis, and Roche. Ruth Plummer declares institutional grants for clinical trial costs from Janssen. Michele Maio declares consulting fees, travel reimbursement, participation in a data safety monitoring board or advisory board, and honoraria from Alfasigmal, Amgen, AstraZeneca, BMS, GSK, Incyte, Lilly, Merck, MSD (consulting fees only), Pierre-Fabre, Roche, Sanofi, and Sciclone; and owns stocks or stock options from Epigen Therapeutics and Theravance. Paolo A. Ascierto declares consulting fees from 4SC, AstraZeneca, BMS, Boehringer-Ingelheim, Daiichi, Eisai, Idera, Immunocore, Italfarmaco, iTeos, Lunaphore, Merck Serono, Merck Sharpe and Dohme, Nektar, Nouscom, Novartis, Oncosec, Pfizer, Pierre-Fabre, Regeneron, Roche/Genentech, Sandoz, Sankyo, Sanofi, Seagen, and Sun Pharma; and institutional grants from BMS, Pfizer, Roche/Genentech, and Sanofi. Enrique Zudaire, Anasuya Hazra, Huybrecht T’jollyn, James G. Greger, Edward Attiyeh, Nibedita Bandyopadhyay, and Hong Xie are employees of Janssen and may own stocks or shares. Emiliano Calvo declares advisory board participation (financial interest) for Adcendo, Alkermes, Amunix, Anaveon, Amcure, AstraZeneca, BMS, Janssen, MonTa, MSD, Nanobiotix, Nouscom, Novartis, OncoDNA, PharmaMar, Roche/Genentech, Sanofi, Servier, SyneosHealth, TargImmune, and T-knife; research grants for Achilles and BeiGene; steering committee (financial interest) and IDMC participation for BeiGene (IDMC steering committee), EORTC IDMC chair (non-financial interest), MedSIR (steering committee), and Novartis (steering committee); honoraria for scientific board participation for Adcendo, Chugai Pharmaceuticals, and PsiOxus Therapeutics; employment at HM Hospitals Group and START Program of Early Phase Clinical Drug Development in Oncology, START corporation, Oncoart Associated, and International Cancer Consultants; and is the founder and president of the not-for-profit Investigational Therapeutics in Oncological Sciences (INTHEOS) Foundation. Aitana Calvo, Andres Cervantes, Dariusz Kowalski, José Manuel Trigo, and Vladimir I. Vladimirov have no relevant disclosures to declare.
: The study was conducted in accordance with the International Council for Harmonisation Good Clinical Practice Standards and the principles set forth in the Declaration of Helsinki. The protocol was approved by institutional and ethics committees at each site.
: All participants provided written informed consent before participation in the study.
: Not applicable.
: Janssen Pharmaceutical Companies of Johnson & Johnson’s data sharing policy is available at ExternalRef removed. As noted on this site, requests for study data access can be submitted through Yale Open Data Access (YODA) Project site at ExternalRef removed.