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The PISCES study: A Multicenter Phase 2, Open-Label Study of Intratumoral Tavokinogene Telseplasmid (tavo, 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
The study will be comprised of a screening period, a treatment period (up to 2 years) and a long term follow-up. Eligible patients will be treated with intratumoral tavo-EP to the accessible lesions on Days 1, 5 and 8 every 6 weeks and with IV pembrolizumab (200mg) on Day 1 of each 3-week cycle for 17 tavo-EP cycles and 33 pembrolizumab cycles (from baseline) of continued treatment (approximately 2 years), or until disease progression. As many accessible lesions may be treated as deemed feasible by the treating physician assuming the size of each lesion is greater than 0.3 cm x 0.3 cm. Long-term Follow-up: All subjects will be followed after End of Study (EOS) visit for SAEs (through 90 days from last dose of study drug) and long term survival status. EOS visit will occur 4 weeks after last study treatment administration.
- To assess objective response rate (ORR) by blinded1 independent central review (BICR) based on RECIST v1.1. - To assess safety and tolerability of the combined treatment in subjects with unresectable or metastatic melanoma who previously have progressed on prior approved anti-PD-1 antibodies (either as monotherapy or in combination with another approved checkpoint inhibitor). - To assess duration of response (DOR), objective response rate (ORR), immune ORR (iORR), progression free survival (PFS), immune PFS (iPFS), and overall survival (OS) of combination therapy. - To assess long-term safety and tolerability of the combination therapy.
Pembrolizumab (Keytruda); Tavo-EP ()