Funding for this research was provided by:
Received: 14 March 2022
Accepted: 24 November 2022
First Online: 12 December 2022
: The study protocol was approved by the Institutional Review Board at AUB. This clinical study is carried out in accordance with the globally accepted standards of GCP and in compliance with applicable regulatory authority requirements.Prior to enrollment in the trial and, written informed consent must be secured from each participant. The investigator explain thoroughly 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.Nivolumab 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 Nivolumab infusion for possible reactions. As part of safety evaluation, newly occurring 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.A Data and Safety Monitoring Board (DSMB) is 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, will periodically examine data accumulated during progress of the study and ensure that benefit/risk ratio remains acceptable for participating patients. The DSMB will independently make its recommendations for continuation, termination or modification of the conduct of the study. The sponsor will timely provide the members of the DSMB with the safety data of the patients. In particular, a safety report will be sent to the DSMB members on the 1rst safety interim analysis (50% of patients accrued) then every 6 months to decide about proceeding with additional recruitment. By that time, they will provide the sponsor with written recommendations whether or not to proceed to the inclusion of the following patients and will give recommendations to change or not the methods of administration. An annual meeting will be held thereafter, and DSMB advices could be sought for any questions regarding the safety and well-being of the patients who will receive the study treatment.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.