Elez, Elena
Cubillo, Antonio
Alfonso, Pilar Garcia
Middleton, Mark R.
Chau, Ian
Alkuzweny, Baha
Alcasid, Ann
Zhang, Xiaosong
Van Cutsem, Eric
Article History
Received: 14 March 2023
Accepted: 20 March 2024
First Online: 11 April 2024
Declarations
:
: The final protocol, any amendments, and informed consent documentation were reviewed and approved by the institutional review boards and independent ethics committees at each of the investigational centers participating in the study. Investigators were required to inform their institutional review boards or independent ethics committees of the study’s progress and occurrence of any serious and/or unexpected adverse events. This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation Good Clinical Practice Guidelines. In addition, all local regulatory requirements were followed, particularly those affording greater protection to the safety of trial participants. The study was approved by the independent ethics committees (Commissie Medische Ethiek—UZ KU Leuven/Onderzoek; METC AVL; CEIC del Hospital General Universitario Gregorio Marañon; East Midlands—Leicester South Research Ethics Committee; Health Research Authority; Schulman Associates IRB; Western Institutional Review Board; Advarra Institutional Review Board; Office of Regulatory Affairs of the University of Pennsylvania; University of Texas MD Anderson Cancer Center; Christiana Care Health System Institutional Review Board; Washington University in St. Louis; UCLA Office of the Human Research Protection Program) in accordance with the Declaration of Helsinki. According to the research ethics guide, all patient information was completely confidential and all stages of the research were performed with patient satisfaction. All experiments were performed in accordance with relevant guidelines and regulations. Informed consent was obtained from all participants before enrollment in the study.
: Not Applicable.
: Elena Elez declares personal financial interest for consulting, advisory roles, honoraria, travel grants, and research grants from Amgen, Bayer, F. Hoffman-La Roche, Merck Serono, Sanofi, Pierre Fabre, MSD, Organon, Novartis, and Servier; institutional financial interest in the form of financial support for clinical trials or contracted research for Amgen, Array Biopharma, AstraZeneca Pharmaceuticals, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Debiopharm International, F. Hoffmann-La Roche, Genentech, HalioDX SAS, Hutchison MediPharma International, Janssen-Cilag, MedImmune, Menarini, Merck Health KGaA, Merck Sharp & Dohme, Merus NV, Mirati, Novartis Farmacéutica, Pfizer, Pharma Mar, Sanofi Aventis Recherche & Développement, Servier, and Taiho Pharma USA.Antonio Cubillo declares there are no competing interests.Pilar Garcia Alfonso declares personal financial interest for consulting, advisory roles, honoraria, travel grants, and research grants from Amgen, F. Hoffman-La Roche, Merck Serono, Sanofi, Pierre Fabre, MSD, Organon, Novartis, and Servier.Mark Middleton reports grants from Roche, grants from AstraZeneca, grants from GSK, personal fees and other from Novartis, grants, personal fees, and other from Immunocore, personal fees and other from BMS, other from Pfizer, personal fees and other from Merck/MSD, other from Regeneron, personal fees and other from BiolineRx, personal fees and non-financial support from Replimune, personal fees from Kineta, personal fees from Silicon Therapeutics, grants from GRAIL, outside the submitted work.Ian Chau declares advisory roles for Eli Lilly, Bristol Meyers Squibb, MSD, Roche, Merck-Serono, AstraZeneca, OncXerna, Pierre Fabre, Boehringer Ingelheim, Incyte, Astella, GSK, Sotio, Eisai, Daiichi-Sankyo, Taiho, Servier, Seagen, Turning Point Therapeutics, and Novartis. Research funding from Eli Lilly and Janssen-Cilag, and an honorarium from Eli Lilly, Eisai, Servier, and Roche.Baha Alkuzweny was formerly an employee of Pfizer.Ann Alcasid is an employee of Pfizer.Xiaosong Zhang is an employee of Pfizer.Eric Van Cutsem declares consulting or advisory roles for Array, AstraZeneca, Bayer, Biocartis, Bristol Myers Squibb, Celgene, Eli Lilly, Ipsen, MSD, Merck KGaA, Novartis, Pierre Fabre, Roche, Servier, Sirtex, and Taiho; and research funding from Amgen, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Ipsen, Merck, Merck KGaA, Novartis, Roche, and Servier.