pIL-12 and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Pembrolizumab or Nivolumab Treatment

Official Title

A Multicentre Phase 2, Open-Label Trial of Intratumoural pIL-12 Plus Electroporation in Combination With Intravenous Pembrolizumab in Patients With Stage III/IV Melanoma Who Are Progressing on Either Pembrolizumab or Nivolumab Treatment

Summary:

This will be a Phase 2 study of intratumoural pIL-12-EP plus IV pembrolizumab. Eligible patients will be those with pathological diagnosis of unresectable or metastatic melanoma who are progressing or have progressed on pembrolizumab or nivolumab..

Trial Description

Primary Outcome:

  • Best Overall Response Rate (BORR)
Secondary Outcome:
  • Objective Response rate
  • Duration
  • Progression free survival (PFS)
  • Overall survival
The study will be comprised of a Core study (24 weeks), an Extension Phase and a long-term safety follow-up. Core study: Eligible patients will be treated with intratumoural pIL-12-EP to the accessible lesions on Days 1, 5 and 8 every 6 weeks and with IV pembrolizumab (200 mg) on Day 1 of each 3-week cycle for 24 weeks. As many accessible lesions, may be treated, as deemed feasible by the treating physician . Extension phase: Patients who completed 24 weeks of treatment (Core study) with the investigators discretion, will enter an Extension phase and continue to receive the combined treatment of intratumoural pIL-12-EP and pembrolizumab for up to 35 cycles of pembrolizumab from baseline (approximately 2 years) or until subsequent disease progression.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society