Damato, Angela http://orcid.org/0000-0001-8286-1274
Iachetta, Francesco
Antonuzzo, Lorenzo
Nasti, Guglielmo
Bergamo, Francesca
Bordonaro, Roberto
Maiello, Evaristo
Zaniboni, Alberto
Tonini, Giuseppe
Romagnani, Alessandra
Berselli, Annalisa
Normanno, Nicola
Pinto, Carmine
Funding for this research was provided by:
Bristol-Myers Squibb
Article History
Received: 8 April 2020
Accepted: 6 August 2020
First Online: 31 August 2020
Ethics approval and consent to participate
: This study is conducted in agreement with either the Declaration of Helsinki or the laws and regulations of the country, whichever provides the greatest protection of the patient. The protocol has been written, and the study is conducted according to the ICH Harmonized Tripartite Guideline for Good Clinical Practice. The study (Protocol version 2.0, January 14th 2019) was approved for all participating centers by AIFA, the Italian health authority (Agenzia Italiana del Farmaco) on February 8th 2019 and registered on August 28th 2019 at Clinicaltrials.gov (NCT04072198). IEC(s)/IRB(s) approved the submitted documents for each center. Company QBE Insurance was appointed by Gruppo Oncologico Italiano Ricerca Clinica (G.O.I.R.C.) for an insurance policy to provide patients for reimbursement to any injury associated with the study. Changes to eligibility criteria, outcomes, analysis or other important protocol modifications will be notified to the IEC/IRB for approval and will be forwarded to the Sponsor. Informed consent to study procedures before enrollment in the study was signed by all candidates; moreover, those will be informed about the study purpose, the activities involved, the expected duration, the potential risks and benefits by the investigators (or legally authorized representative).
: Not applicable.
: The authors declare no conflict of interest.