drugset / Trial / NCT04283890

PHP and Immunotherapy in Metastasized UM

NCT04283890

Phase 1/2 Active not recruiting 83 enrolled Leiden University Medical Center
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

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 1 mg/kg Intravenous
Subject Melphalan Small molecule 3 mg/kg Other
Subject Nivolumab Monoclonal antibody 3 mg/kg Intravenous

Indications