Evaluating the Effect of Nivolumab for Patients With In-transit Metastases Treated With Isolated Limb Perfusion

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

April 1, 2019

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2029

Conditions
MelanomaIn-Transit Metastasis
Interventions
DRUG

Nivolumab

One infusion of nivolumab (Opdivo®) 480mg (flat dose) in NaCl (Natriumklorid Baxter Viaflo, 9 mg/ml) during 60 minutes

PROCEDURE

Isolated limb perfusion (ILP)

Patients will be treated with ILP according to clinical routine at each separate site. The procedure is performed under general anaesthesia. The major artery and vein of the limb is catheterized, and a tourniquet is placed proximally on the limb. Continuous leakage monitoring is performed. The perfusate is heated to 40C and after ensuring steady state, melphalan (Alkeran®) at a dose of 13 mg/L (upper limb) or 10 mg/L (lower limb) is infused into the circulation during 20 minutes for a total perfusion time of 60 minutes. According to local routine tasonermin (Beromun®) will be added to the perfusate 30 minutes before the melphalan as a bolus dose of 1-4 mg.

Trial Locations (4)

Unknown

RECRUITING

Netherlands Cancer Institute, Amsterdam

NOT_YET_RECRUITING

Erasmus MC Cancer Institute, Groningen

NOT_YET_RECRUITING

Erasmus MC Cancer Institute, Rotterdam

413 45

RECRUITING

Sahlgrenska University Hospital, Gothenburg

All Listed Sponsors
lead

Vastra Gotaland Region

OTHER_GOV