Martinelli, Erika
Ciardiello, Davide
Martini, Giulia
Napolitano, Stefania
Del Tufo, Sara
D’Ambrosio, Luca
De Chiara, Marco
Famiglietti, Vincenzo
Nacca, Valeria
Cardone, Claudia
Avallone, Antonio
Cremolini, Chiara
Pietrantonio, Filippo
Maiello, Evaristo
Granata, Vincenza
Troiani, Teresa
Cappabianca, Salvatore
Ciardiello, Fortunato
Nardone, Valerio
Reginelli, Alfonso
Funding for this research was provided by:
Regione Campania (Cup 21C17000030007)
Merck Healthcare KGaA (Grant)
Article History
Accepted: 26 May 2024
First Online: 17 June 2024
Declarations
:
: This was an academic nonprofit study, conducted in the Gruppo Oncologico dell’Italia Meridionale (GOIM) clinical research network. Cetuximab and avelumab were provided by Merck KGaA, Darmstadt, Germany. Two research grants, that partially covered the costs of the study, were provided by Merck and by Regione Campania (I-Cure Research Project, Grant number: Cup 21C17000030007).
: Prof. Martinelli reported receiving travel grants from AstraZeneca and Pierre Fabre and being an advisory board member for AstraZeneca, Bayer, Amgen, Merck KGaK, Roche, Sanofi, Servier and Pierre Fabre outside the submitted work. Dr. D Ciardiello, reported receiving travel grants from Sanofi, BMS and Merck KGaA outside the submitted work. Dr. Martini reported honoraria from Servier and Incyte outside the submitted work. Dr. Napolitano reported that received travel grants from Amgen and Merck KGaA outside the submitted work. Dr. Cardone reported receiving personal fees from Bayer outside the submitted work. Dr. Avallone reported receiving personal fees for consulting from Amgen, AstraZeneca, MSD and Eisai and being an advisory board member for Amgen and Servier outside the submitted work. Prof. Cremolini reported receiving honoraria from Amgen, Bayer, Merck, Pierre Fabre, Roche and Servier. Consulting or advisory role for Amgen, Bayer, MSD, Nordic Pharma, Roche, Takeda. Speakers’ Bureau for Amgen, Pierre Fabre, MSD, Servier. Research funding from Amgen, Bayer, Merck, Servier. Dr. Pietrantonio reported receiving research grants from Incyte, Lilly, Bristol Myers Squibb, Amgen, Agenus and AstraZeneca and honoraria from Bristol Myers Squibb, Amgen, Merck Serono, Bayer, Takeda, GSK, Ipsen, Astellas, Servier, MSD, and Pierre Fabre outside the submitted work. Dr. Maiello has served as advisor and speaker for AstraZeneca, Eli Lilly, Servier, Sanofi Genzyme, Roche, Merck, Eisai, Pfizer outside the submitted work. Prof. Troiani reported receiving travel grants from AstraZeneca and Pierre Fabre and being an advisory board member for AstraZeneca, Bayer, Amgen, Merck KGaK, Roche, Sanofi, Servier and Pierre Fabre outside the submitted work. Prof. Ciardiello F reported serving on the advisory board for Amgen and Servier during the conduct of the study and serving on the advisory board for MSD, Merck KGaA, Roche, Pfizer, Bayer, Pierre Fabre and Eisai outside the submitted work. All other authors declare no competing interests.
: The CAVE-mCRC trial was approved by the Ethic Committee of Università degli Studi della Campania Luigi Vanvitelli, Azienda Ospedaliera Universitaria-AORN “Ospedali dei Colli”, Napoli, Italy. CAVE-mCRC trial is registered with Eudract.ema.europa.eu, EudraCT number: 2017-004392-32 and ClinicalTrial.gov identifier: NCT04561336.
: All patients provided written informed consent before entering the trial.
: Not applicable.
: The data that support the findings of our study and further information are available from the corresponding author upon reasonable request.
: Not applicable.
: Prof. E. Martinelli, Dr. D. Ciardiello, Dr. V. Nardone, Prof. F. Ciardiello, had full access to all of the data in the study and are accountable for the integrity and the accuracy of the data analysis. Conception and Design of the Trial Conceptualization: Martinelli E, Ciardiello D, Nardone V, Martini G, Ciardiello F and Reginelli A. Financial support: Ciardiello. Acquisition, analysis and interpretation of the clinical data: all authors. Data curation: all authors. Statistical formal analysis: Nardone V, Famiglietti. Translational research data analysis and interpretation: Martinelli E, Ciardiello D, Ciardiello F. Writing of the manuscript-original draft: Martinelli E, Ciardiello D, Ciardiello F, and Nardone V. Final approval of the manuscript Writing – review and editing: all authors. The work reported in the paper has been performed by the authors, unless clearly specified in the text.