PHP in Combination With IPI1/NIVO3 Compared to IPI3/NIVO1 Only in Patients With Uveal Melanoma Liver Metastases

PHASE3RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

June 10, 2024

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2030

Conditions
Uveal MelanomaLiver Metastases
Interventions
DEVICE

PHP

Patients will be treated with 2 cycles of PHP (CHEMOSAT® Hepatic Delivery System for Melphalan) six weeks apart

DRUG

IPI1/NIVO3

Patients will be treated with 2 cycles of i.v. ipilimumab 1mg/kg and nivolumab 3mg/kg q3w, followed by continued i.v. nivolumab 480mg q4w up to 1 year.

DRUG

IPI3/NIVO1

Patients will be treated with 4 cycles of intravenous (i.v.) infusion with ipilimumab 3mg/kg and nivolumab 1mg/kg q3w followed by continued i.v. nivolumab 480mg q4w up to 1 year.

Trial Locations (6)

Unknown

RECRUITING

Sahlgrenska University Hospital, Gothenburg

NOT_YET_RECRUITING

Linköping University Hospital, Linköping

NOT_YET_RECRUITING

Skåne University Hospital, Lund

RECRUITING

Karolinska University Hospital,, Stockholm

NOT_YET_RECRUITING

Norrland University Hospital, Umeå

RECRUITING

Uppsala University Hospital, Uppsala

All Listed Sponsors
lead

Vastra Gotaland Region

OTHER_GOV