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

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.

Trial Details

NCT ID
NCT03685890
Phase
PHASE1 / PHASE2
Sponsor
Vastra Gotaland Region
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Nivolumab
  • Isolated limb perfusion (ILP)
Locations (sample)
  • Amsterdam, Netherlands|52.37403,4.88969
  • Groningen, Netherlands|53.21917,6.56667
  • Rotterdam, Netherlands|51.9225,4.47917
  • Gothenburg, Sweden|57.70716,11.96679

Key Eligibility Criteria

  • Male or female aged above 18 years.
  • Signed and dated written informed consent before the start of specific protocol procedures.
  • Histologically or cytologically proven in-transit metastases of malignant melanoma with or without regional lymph node metastases (AJCC v8 stage N1…
  • Measurable disease with at least 1 metastasis measuring at least 5mm

For full eligibility, visit ClinicalTrials.gov.

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