74
Participants
Start Date
April 1, 2019
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2029
Nivolumab
One infusion of nivolumab (Opdivo®) 480mg (flat dose) in NaCl (Natriumklorid Baxter Viaflo, 9 mg/ml) during 60 minutes
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.
RECRUITING
Netherlands Cancer Institute, Amsterdam
NOT_YET_RECRUITING
Erasmus MC Cancer Institute, Groningen
NOT_YET_RECRUITING
Erasmus MC Cancer Institute, Rotterdam
RECRUITING
Sahlgrenska University Hospital, Gothenburg
Vastra Gotaland Region
OTHER_GOV