drugset / Trial / NCT04283890
PHP and Immunotherapy in Metastasized UM
RandomizedFactorialOpen-labelTreatment
Summary
Melanoma of the eye (ocular/uveal melanoma) is an uncommon type of cancer that is associated with a high mortality. It usually disseminates rapidly throughout the body, most commonly to the liver and lungs. In this study a combination therapy with immunotherapy (ipilimumab with nivolumab) and chemotherapy (melphalan) will be assessed for the treatment of disseminated uveal melanoma. Melphalan will be administered selectively to the liver via percutaneous hepatic perfusion, limiting the systemic effect of chemotherapy. With this treatment combination we aim to find a treatment for disseminated uveal melanoma, both in the liver as in the other organs.
Timeline
- Start
- 2019-12-04
- Primary completion
- 2026-12
- Completion
- 2029-12
Publications
- van den Hoek L, Burgmans M, Tong T, Goeman J, Speetjens F, Zunder S, van Erkel A, van der Meer R, van Rijswijk C, Lutjeboer J, Koolhaas D, Jonker-Bos M, Roozen I, Kropff S, van Meerten EVP, Zoethout R, Sitsen E, Helmerhorst H, Tijl F, Blank C, Kapiteijn E. Percutaneous hepatic perfusion combined with ipilimumab and nivolumab for metastatic uveal melanoma (CHOPIN): a single-centre, open-label, randomised, phase 2 trial. Lancet Oncol. 2026 Mar;27(3):372-382. doi: 10.1016/S1470-2045(25)00720-X.
- Tong TML, van der Kooij MK, Speetjens FM, van Erkel AR, van der Meer RW, Lutjeboer J, van Persijn van Meerten EL, Martini CH, Zoethout RWM, Tijl FGJ, Blank CU, Burgmans MC, Kapiteijn E. Combining Hepatic Percutaneous Perfusion with Ipilimumab plus Nivolumab in advanced uveal melanoma (CHOPIN): study protocol for a phase Ib/randomized phase II trial. Trials. 2022 Feb 13;23(1):137. doi: 10.1186/s13063-022-06036-y.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Melphalan | Small molecule | 3 mg/kg | Other |
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | Intravenous |