Article Content

The FDA awarded Fast Track designation to ImmunoPulse IL-12, a potentially first-in-class, intratumoral anti-cancer gene therapy that expresses interleukin-12 (IL-12) for the treatment of metastatic melanoma, following progression on pembrolizumab or nivolumab.

FDA; ImmunoPulse IL-... - Click to enlarge in new windowFDA; ImmunoPulse IL-12. FDA; ImmunoPulse IL-12

The PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study) will be a phase IIb, Simon two-stage, non-comparative, open-label, single-arm, multicenter study of ImmunoPulse IL-12 (intratumoral pIL-12 plus electroporation) in combination with an IV anti-PD-1 antibody in patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as stage III or IV.


Eligible patients will be those with stage III/IV metastatic melanoma who are progressing or have progressed according to RECIST v1.1 guidelines on, or within, 24 weeks of receiving approved anti-PD-1 antibodies on either pembrolizumab or nivolumab treatment (either as monotherapy or in combination with another approved checkpoint inhibitor).


The primary endpoint for this registration-directed trial will be overall response rate at 24 weeks with secondary endpoints of best overall response rate, duration of response, median progression-free survival, and overall survival. This clinical trial is planned to initiate in the first half of 2017.