Evaluating the Effect of Nivolumab for Patients With In-transit Metastases Treated With Isolated Limb Perfusion
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study summary
To evaluate safety and the effect of isolated limb perfusion together with nivolumab as a way to increase efficacy and give further insights in early immunological mechanisms.
In the first phase Ib part, 20 patients will be enrolled and followed for a minimum of 3 months. An independent data safety monitoring board (DSMB) will continuously review safety and judge the seriousness of the events and also recommend the study to stop if necessary. If the DSMB do not find safety issues, the trial will continue as a phase II trial.
Eligibility
Primary outcome measure(s)
- Complete response rate (CR) — 3 months
To evaluate if melphalan based isolated limb perfusion (ILP) synergizes with nivolumab in inducing complete responses (CR) at 3 months after treatment in melanoma patients with in-transit metastasis.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Netherlands Cancer Institute | Amsterdam | Netherlands | Recruiting |
| Erasmus MC Cancer Institute | Groningen | Netherlands | Not Yet Recruiting |
| Erasmus MC Cancer Institute | Rotterdam | Netherlands | Not Yet Recruiting |
| Sahlgrenska University Hospital | Gothenburg | Sweden | Recruiting |
On this site
📄 Opdivo (nivolumab) drug profile →More Vastra Gotaland Region trials in the Netherlands
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03685890 on ClinicalTrials.gov ↗ ← All trials in the Netherlands