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. Stage IV and unresectable Stage
III metastatic melanoma patients with at least one injectable lesion (i.e., cutaneous,
subcutaneous, soft tissue, superficial nodal or palpable nodal lesion suitable for injection
with PV-10) who are candidates for pembrolizumab 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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