This is a multi-center, Phase II, open label, single-arm trial of intratumoral pIL-12 EP in combination with pembrolizumab in patients with low TIL melanoma. Patients will initiate treatment of pembrolizumab concurrently with the first cycle of intratumoral pIL-12 EP. Pembrolizumab will be administered at 200 mg flat dose every 3 weeks. Cycles of intratumoral pIL-12 EP (each cycle consisting of treatment on days 1, 5 and 8) will occur every 6 weeks as long as patients have accessible lesions for EP. Patients will be evaluated for response every 12 weeks by RECIST v1.1. Patients will continue on therapy if they have stable disease or better, defined under investigator evaluation at the time of disease evaluations. Therapy will be given until disease progression or unacceptable toxicity. The only exception will be those patients who experience a confirmed CR and who have been on treatment for at least 6 months; these patients may discontinue treatment at the investigator's discretion. Patients may reinitiate either therapy post-complete remission relapse if the study remains open and the patient meets the conditions outlined in the protocol. Patients will be followed continually for safety and tolerability by assessment of adverse events.
An Open-label, Phase II, Multicenter Study of Enhancing Pembrolizumab Responses in Melanoma Through Intratumoral pIL-12 Electroporation
Open to people ages 18 years and up
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