RecruitingPhase 1Phase 2NCT03685890

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

A Phase Ib/II Randomized Double-blind Placebo Controlled Trial Evaluating the Effect of Nivolumab for Patients With In-transit Melanoma Metastases Treated With Isolated Limb Perfusion - the NivoILP Trial

Sponsor

Vastra Gotaland Region

Enrollment

74 participants

Start Date

Apr 1, 2019

Study Type

INTERVENTIONAL

Conditions

Melanoma In-Transit Metastasis

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether adding nivolumab (an immune-boosting cancer drug) to a procedure called isolated limb perfusion — a technique that delivers high-dose chemotherapy directly to a limb — is more effective than the procedure alone in treating melanoma that has spread within the skin or tissues of an arm or leg. **You may be eligible if...** - You are 18 or older - You have been diagnosed with melanoma that has spread within a limb (called in-transit metastases), confirmed by tissue biopsy - At least one visible melanoma lesion is 5mm or larger - You are well enough to tolerate general anesthesia **You may NOT be eligible if...** - Your life expectancy is less than 6 months - You are pregnant or breastfeeding - You have serious heart problems that prevent general anesthesia - You have severe lung disease - You have significant kidney, liver, or blood count problems - You have an active autoimmune disease (some autoimmune conditions may be allowed) - You are currently taking immune-suppressing medications like steroids - You have a history of serious lung inflammation (pneumonitis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab

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

PROCEDUREIsolated 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.