Multicenter randomized trial of deferred cytoreductive nephrectomy in synchronous metastatic renal cell carcinoma receiving checkpoint inhibitors: the NORDIC-SUN-Trial.

"Declarations Ethics approval and consent to participateThe study is conducted according to the guidelines of the Declaration of Helsinki and approved by the Danish National Center for Ethics (1–10-72–158-19, version 2.0 approved 14–09-2023 l). The patient should be informed about the protocol prior to the diagnostic (routine) biopsy in order to have the fresh baseline biopsy to coincide with the diagnostic (routine) biopsy, thereby avoiding delay in systemic therapy initiation. It is the responsibility of the investigator, or a person designated by the investigator (if acceptable by local regulations), to obtain written informed consent from each patient participating in this study, after adequate explanation of the aims, methods, anticipated benefits, and potential hazards of the study. Patient information is collected and maintained in an Aarhus University controlled REDCap database by the project nurse and the responsible data manager. Consent for publicationNot applicable. Competing interestsNF has performed consultancy for Pfizer, Eisai, MSD, BMS, and has received speaker honoraria from AstraZeneca, BMS, MSD. BL: Company speaker: Novartis, IPSEN, BMS; Company consultant: Janssen, Ipsen, MSD; Trial participation: Jenssen—Astellas – Medivation. AB: grants from Pfizer and steering committee membership of Roche and BMS, consultancy for IPSEN. The other authors declare no conflicts of interest. Competing interests NF has performed consultancy for Pfizer, Eisai, MSD, BMS, and has received speaker honoraria from AstraZeneca, BMS, MSD. BL: Company speaker: Novartis, IPSEN, BMS; Company consultant: Janssen, Ipsen, MSD; Trial participation: Jenssen—Astellas – Medivation. AB: grants from Pfizer and steering committee membership of Roche and BMS, consultancy for IPSEN. The other authors declare no conflicts of interest."

"Funding The trial and analysis are supported by The Danish Health Authority (05–0400-48) after international peer-review. While molecular analyses and salaries are supported by the Lundbeck Foundation (R413-2022–606), the Danish Cancer Society (R352-A20516), DCCC Danish Research Centre for circulating tumor DNA guided treatment (20230426_2), and the Independent Research Fund Denmark (2100-00017B). Lundbeck Foundation,R413-2022-606,Kræftens Bekæmpelse,R352-A20516,DCCC Danish Research Centre for circulating tumor DNA guided treatment,20230426_2,Danmarks Frie Forskningsfond,2100-00017B,The Danish Health Authority,05-0400-48 "

"Trial registration ClinicalTrials.gov NCT03977571 June 6, 2019."