A Phase I open label dose escalation trial of plasmid interleukin-12 (IL-12) electroporation was carried out to assess safety and explore anti-tumor activity in 24 patients with metastatic melanoma. Patients were treated at seven dose levels, with minimal systemic toxicity. Transient pain (Grades 1 and 2) associated with the electroporation procedure was the most frequently reported adverse event. Post-treatment biopsies showed plasmid increases in IL-12 protein levels as well as marked tumor necrosis and lymphocytic infiltrate. Two (10%) of 19 patients with nonelectroporated distant lesions that did not receive other systemic therapy had a complete response to therapy, including metastatic disease, whereas eight additional patients (42%) showed disease stabilization.
OBJECTIVES: Assess the safety and overall objective response rate by modified “skin” RECIST criteria of intratumoral injection of pIL-12 electroporation in patients with in-transit cutaneous and subcutaneous metastatic melanoma
Phase II single-arm, open-label, trial in Merkel Cell Carcinoma (MCC) to evaluate IL-12 protein expression following intratumoral injection of pIL-12 followed by electroporation. Other study endpoints include evaluating anti-tumor activity, safety, and intratumoral biomarkers of inflammation.
Multicenter Phase II Trial of Intratumoral pIL-12 Electroporation in Treatment-Refractory Metastatic and Unresectable Squamous Cell Carcinoma of the Head and Neck Phase II trial to assess the safety and effectiveness of intratumoral pIL-12 DNA injection with electroporation in treatment-refractory metastatic and unresectable squamous cell carcinoma of the head and neck. This study is ongoing, but not recruiting participants.