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 tavokinogene telseplasmid (tavo; pIL-12) Electroporation (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:

  • Overall Response Rate (ORR)
Secondary Outcome:
  • Objective Response rate (ORR)
  • Duration of Response (DOR)
  • Progression free survival (PFS)
  • Immune Progression Free Survival (iPFS)
  • Immune Overall Response Rate (iORR)
  • Overall survival (OS)
The study will be comprised of a screening period, a treatment period (up to 2 years) and a long term follow-up. Eligible patients will be treated with intratumoural tavo-EP to the accessible lesions on Days 1, 5 and 8 every 6 weeks and with IV pembrolizumab (200mg) on Day 1 of each 3-week cycle for 17 tavo-EP cycles and 33 pembrolizumab cycles (from baseline) of continued treatment (approximately 2 years), or until disease progression. As many accessible lesions may be treated as deemed feasible by the treating physician assuming the size of each lesion is greater than 0.3 cm x 0.3 cm. Long-term Follow-up: All subjects will be followed after End of Study (EOS) visit for SAEs (through 90 days from last dose of study drug) and long term survival status. EOS visit will occur 4 weeks after last study treatment administration.

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