Title {1} | Combining Hepatic Percutaneous Perfusion with Ipilimumab plus Nivolumab in advanced Uveal Melanoma (CHOPIN): Study protocol for a phase Ib/randomized phase II Trial. |
Trial registration {2a and 2b}. |
U.S. National Library of Medicine: NCT04283890 EudraCT registration number: 2018-004248-49 |
Protocol version {3} | Version 06, December 2020 |
Funding {4} | In kind contribution from Bristol-Myerss Squibb and Delcath Systems Inc. |
Author details {5a} |
T.M.L. Tong1,2, M.K. van der Kooij1, F.M. Speetjens1, A.R. van Erkel2, R.W. van der Meer2, J. Lutjeboer2, E.L. van Persijn van Meerten2, C.H. Martini3, R.W.M. Zoethout3, F.G.J. Tijl4, C.U. Blank1,5, M.C. Burgmans2, E. Kapiteijn1 1) Department of Medical Oncology, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands 2) Department of Radiology, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands 3) Department of Anesthesiology, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands 4) Department of Extra Corporal Circulation, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands 5) Department of Medical Oncology, The Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital (NKI-AVL), PO Box 90203, 1006 BE Amsterdam, The Netherlands Corresponding author: Ms. T.M.L. Tong, T.M.L.Tong@lumc.nl |
Name and contact information for the trial sponsor {5b} |
Leiden University Medical Center Prof. Dr. A.J. Gelderblom Head of the department of Medical Oncology, C-7-P PO Box 9600, 2300 RC Leiden Email: A.J.Gelderblom@lumc.nl |
Role of sponsor {5c} |
This is an investigator-initiated trial. Leiden University Medical Center is the only participating center. Bristol-Myers Squibb contributes to the study with the supply of ipilimumab and nivolumab. Delcath Systems Inc. contributes to the study by supplying the kits for the percutaneous hepatic perfusion procedure. |