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A Multicenter Phase 2, Open-Label Trial of Intratumoral 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
OncoSec Medical Incorporated
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 intratumoral 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 intratumoral pIL-12-EP and pembrolizumab for up to 35 cycles of pembrolizumab from baseline (approximately 2 years) or until subsequent disease progression.