A Phase 1b/2 Study of PV-10 Intralesional Injection in Combination with Systemic Immune Checkpoint Inhibition for Treatment of Metastatic Melanoma
This is an international multicenter, open-label, sequential phase study of intralesional
(IL) PV-10 in combination with immune checkpoint inhibition. Metastatic melanoma patients
(Stage IV or Stage III unresectable, in-transit or satellite disease) with at least one
injectable lesion who are candidates for pembrolizumab (both treatment naïve patients and
treatment refractory patients who have failed to achieve a complete or partial response to or
previously progressed on one or more checkpoint inhibitor) will be eligible for study
participation. In the Phase 1b portion of the study, all participants will receive the
combination of IL PV-10 and pembrolizumab (i.e., PV-10 + standard of care). In the subsequent
Phase 2 portion of the study participants will be randomized 1:1 to receive either the
combination of IL PV-10 and pembrolizumab or pembrolizumab alone (i.e., PV-10 + standard of
care vs. standard of care).
View more details from ClinicalTrials.gov.
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Please Note: Any eligibility criteria noted are subject to change. Our research nurses can provide you with the most current eligibility and exclusion criteria. Any study involvement to be undertaken must ultimately be determined on an individual basis.