Document is current

Article History

Received: 22 November 2024

Accepted: 10 August 2025

First Online: 29 December 2025

Declarations

:

: Jonathan Zager–global principal investigator in the FOCUS phase 3 study and serves on Delcath Systems Medical Advisory Board. Education and Training grant through Delcath. Marlana Orloff–Advisory Board: Delcath, Replimune. Consultant: Immunocore. Steering Committee: Ideaya. Speaker: Immunocore. David Eschelman–Received < $5 K consulting fees from Delcath. Evan Glazer–My institution was a site for the clinical trial. I received no direct payment. Delcath paid for the clinical trial to my institution. Erika Richtig–Medical University of Graz received payments for conducting the Phase 3 study. Sebastian Ochsenreither–Advice: Immunocore, Delcath, Janssen. Speakers’ bureau: Immunocore. Georgia Beasley–Clinical trial funding paid to institution from Replimune, checkmate pharmaceuticals, Philogen, Delcath. Advisory board BMS 10.2023. Anja Gesierich–University Hospital Würzburg received payments for conducting the Phase 3 study. Reinhard Dummer–intermittent, project focused consulting and/or advisory relationships with Novartis, Merck Sharp & Dhome (MSD), Bristol-Myers Squibb (BMS), Roche, Amgen, Takeda, Pierre Fabre, Sun Pharma, Sanofi, Catalym, Second Genome, Regeneron, Alligator, T3 Pharma, MaxiVAX SA, Pfizer, Sim-cere and touchIME outside the submitted work. Ana Arance–Consulting or advisory role: Pierre- Fabre, Novartis, Roche, BMS, MSD, Biontech. Speakers’ Bureau: Pierre- Fabre, Novartis, Roche, BMS, MSD. Travel, Accommodations, Expenses: BMS, MSD. Stephen Fenwick–Liverpool University Hospitals NHS Trust received support for conducting this Phase 3 study from the trial sponsor. Joseph Sacco–I have been a paid member of advisory boards for Delcath, Replimune and Immunocore. I have received grant funding from Astra Zeneca and BMS (paid to institution). I have had travel and conference attendance paid for by MSD, BMS and Replimune. Johnny John is an employee of Delcath Systems Inc. Matthew Wheater–Institutional (University Hospital Southampton) funding for conducting a commercial trial. Personal funding for participation in advisory board for Delcath. Pier Francesco Ferrucci, Junsung Choi, Aslam Ejaz, Sunil A. Reddy, Michael C. Lowe, Martin Gschnell, and Christian H. Ottensmeier have nothing to disclose.