Rohaan, Maartje W.
Stahlie, Emma H. A.
Franke, Viola
Zijlker, Lisanne P.
Wilgenhof, Sofie
van der Noort, Vincent
van Akkooi, Alexander C. J.
Haanen, John B. A. G.
Funding for this research was provided by:
Amgen Nederland
Article History
Received: 10 March 2022
Accepted: 13 July 2022
First Online: 4 August 2022
Declarations
:
: The study protocol, the patient informed consent and all forms of participant information related to the study have been reviewed and approved by the Central Committee on Research Involving Human Subjects (CCMO) on 4th June 2020, reference number NL71866.000.19, the Ministry of Health, Welfare and Sport as Competent Authority, the Board of Directors of the NKI, and the collaborating party Amgen Inc. as providers of the study drug T-VEC. Any substantial amendments made to the study documents will be submitted and reviewed as a modification and must be approved by the CCMO, the Ministry of Health, Welfare and Sport as Competent Authority, the Board of Directors of the NKI and Amgen Inc. before implementation. The protocol was written and the study was conducted according to the ICH Harmonized Tripartite Guideline for Good Clinical Practice (GCP), the Declaration of Helsinki and the Medical Research Involving Human Subjects Act (WMO).Prior to participation, all patients will be informed of the aims of the study, the possible AEs, the procedures and possible hazards to which he/she will be exposed. They will be informed as to the strict confidentiality of their patient data, but that their medical records may be reviewed for trial purposes by authorized individuals other than their treating physician. It will be emphasized that the participation is voluntary and that the patient is allowed to refuse further participation in the protocol whenever he/she wants. This will not prejudice the patient’s subsequent care. Documented informed consent will be obtained for all patients included in the study before they are registered in the study. This will be done in accordance with the national and local regulatory requirements. The informed consent procedure will conform to the ICH guidelines on GCP. This implies that “the written informed consent form will be signed and personally dated by the patient or by the patient’s legally acceptable representative”.The patient material will be stored at the pathology department and the core facility molecular pathology and biobanking at the NKI. The PBMCs will be generated from peripheral blood according to local protocol and stored at the immunology division of the NKI. Material that is not used for current translational research will be stored for up to 15 years after end of study.
: Not applicable.
: MR declares to have no competing interests. ES declares to have no competing interests. VF declares an advisory role/consultancy agreement and travel/research grant from Amgen Inc. LZ declares to have no competing interests. SW declares to have no competing interests. VvdN declares to have no competing interests. Through AvA, NKI has received compensation for advisory roles from Amgen, BMS, Novartis, MSD-Merck, Merck-Pfizer, Pierre Fabre, Sirius Medical, Sanofi and 4SC and NKI has received grants from Amgen, Merck-Pfizer. JH received compensation (all paid to the institute except for Neogene Therapeutics) for advisory roles for Achilles Therapeutics, BioNTech, BMS, Gadeta, Immunocore, Instil Bio, Iovance Biotherapeutics, Ipsen, MSD, Merck Serono, Molecular Partners, Neogene Therapeutics, Novartis, Pfizer, Roche/Genentech, Sanofi, Third Rock Ventures, and T-knife, and has received grants (all paid to the institute) from Amgen, Asher Bio, BioNTech, BMS, MSD, Novartis, and Neogene Therapeutics.