Shamseddine, Ali
Zeidan, Youssef H.
Kreidieh, Malek
Khalifeh, Ibrahim
Turfa, Rim
Kattan, Joseph
Mukherji, Deborah
Temraz, Sally
Alqasem, Kholoud
Amarin, Rula
Al Awabdeh, Tala
Deeba, Samer
Jamali, Faek
Mohamad, Issa
Elkhaldi, Mousa
Daoud, Faiez
Al Masri, Mahmoud
Dabous, Ali
Hushki, Ahmad
Jaber, Omar
Khoury, Clement
El Husseini, Ziad
Charafeddine, Maya
Al Darazi, Monita
Geara, Fady
Funding for this research was provided by:
Merck KGaA (Unknown)
Article History
Received: 29 January 2020
Accepted: 24 August 2020
First Online: 1 September 2020
Ethics approval and consent to participate
: The study protocol was approved by the appropriate independent ethics committee (IEC) corresponding to each of the three centers, including the Institutional Review Board at AUBMC, Institutional Review Board at king Hussein Medical Center and Ethics committee at Hotel Dieu de France. This clinical study is carried out in accordance with the globally accepted standards of GCP and in compliance with applicable regulatory authority requirements<i>.</i>Prior to enrollment in the trial and, written informed consent must be secured from each participant. The investigator explain thoroughly the the study objectives and procedures as well as the list of possible risks related to the study procedure and medicine.. The patient will be given enough time to read and question the study details, in a matter that all his/her questions should be answered in a clearly. His/her right to withdraw from the study at any time must be made clear. Two original copies of the informed consent form should be signed and dated by the patient, or a designated person, and by the Investigator.Given the investigational nature of the IMP and in order to provide subjects with the maximum level of safety in case of unexpected events, several requirements must be fulfilled before any administration to the subjects.Avelumab should be administered in a setting that allows for immediate access to an intensive care unit or equivalent environment to implement immediate resuscitation measures. Steroids, epinephrine, allergy medications, bronchodilators, and oxygen should be available for immediate access. Properly qualified and trained medical personnel must also be present.patients must be observed for 30 min post Avelumab infusion for possible reactions. As part of safety evaluation, newly occurring adverse events (AEs) or worsening conditions that take place after the date of signing the informed consent must be recorded on the AEs electronic Case Report Form (eCRF). The American University of Beirut will contract civil liability insurance to provide patients with compensation for any injury, related to the IMP or the study procedures.DSMB will also be constituted to ensure patient safety. The DSMB is an expert committee, independent from the investigators and the sponsor of the clinical study, which includes experts with prior clinical extended experience in immunotherapy and cancer and a significant involvement in clinical research. The sponsor will timely provide the DSMB members with the safety data of the first 13 patients accrued from all centers at stage one in order for the committee to decide whether or not to proceed with the second stage of the study and to recommend changes to the methods of IMP administration, if any.Any study finding that might jeopardize the patient safety should be communicated directly from the PI to the study investigators and study personnel.. In addition, The principal investigator will communicate additional safety information to the appropriate health authorities/IECs, as soon as it becomes available.A patient may be withdrawn from the study and his/her treatment discontinued at any time following the occurrence of an AE that, to the judgment of the investigator or the principal investigator, may interfere with study conduct or study results.
: Not Applicable.
: The authors declare that they have no competing interests.