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The FDA has granted Orphan Drug Designation for pIL-12 (tavokinogene telsaplasmid) for the treatment of unresectable metastatic melanoma. Tavokinogene telsaplasmid is the active biologic agent in ImmunoPulse IL-12.

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The registration-directed PISCES trial is being initiated to evaluate the safety and efficacy of ImmunoPulse IL-12 and the approved anti-PD-1 agent, pembrolizumab, in patients with metastatic melanoma following disease progression on previous treatment with an anti-PD-1 therapy.


PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study) will be a phase II multicenter study of ImmunoPulse IL-12 in combination with pembrolizumab in patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as stage III or stage IV.


Eligible patients will be those with stage III/IV metastatic melanoma who are progressing or have progressed on an approved anti-PD-1 therapy. The primary endpoint for this registration-directed trial is best overall response rate.