A Phase 1 Safety and Tolerability Study of Intralesional PV-10 Chemoablation in Subjects With Metastatic Melanoma
This is a two center, open label, ascending dose study. Subjects with at least two
measurable melanoma lesions will receive a single intralesional injection of 10% PV-10
solution into each of one to twenty (20) target lesions. Additionally, one to three
measurable untreated non-target lesions will be followed for assessment of bystander
response. Systemic and locoregional adverse events will be monitored over the study
interval. Dose escalation will be made only if no subjects at the first dose level have a
Grade 3 non-hematological or Grade 4 hematological toxicity over a period of two weeks after
PV-10 administration. Subject accrual and PV-10 administration at the second dose level
will be stopped if more than 1 subject has a treatment related Grade 3 non-hematological or
Grade 4 hematological toxicity within a period of two weeks after PV-10 administration.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety: adverse experience
Eric Wachter, Ph.D.
United States: Food and Drug Administration