Isolated Hepatic Perfusion in Combination With Ipilimumab and Nivolumab in Patients With Uveal Melanoma Metastases

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

March 8, 2021

Primary Completion Date

July 26, 2024

Study Completion Date

July 26, 2024

Conditions
Uveal MelanomaLiver Metastases
Interventions
PROCEDURE

Isolated hepatic perfusion

The procedure is performed under general anaesthesia. The caval vein is isolated infrahepatically above the renal veins and suprahepatically between the diaphragm and the pericardium. A catheter is placed in the retrohepatic portion of the caval vein for perfusion outflow. The portal vein is clamped and the proper hepatic artery is cannulated via the gastroduodenal artery. The liver perfusion is performed at a rate of 8- 9 ml/kg/min with a target liver temperature of 40 degrees Celsius. The leakage from the system was continuously recorded using Technetium labelled albumin (Vasculosis) injected into the perfusion circuit. Melphalan (1 mg/kg bodyweight divided into two doses, given 30 minutes apart) is added to the perfusion system. The perfusion is then continued for 60 minutes, after which the perfusion was discontinued.

DRUG

Ipilimumab

4 courses of ipilimumab 3mg/kg every third week

DRUG

Nivolumab

4 courses of nivolumab 1mg/kg every third week

Trial Locations (1)

413 45

Sahlgrenska University Hospital, Gothenburg

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Vastra Gotaland Region

OTHER_GOV