PV-10 Intralesional Injection vs Systemic Chemotherapy or Intralesional Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
This is an international multicenter, open-label, randomized controlled trial (RCT) of
single-agent intralesional PV-10 versus systemic chemotherapy or intralesional oncolytic
viral therapy to assess treatment of locally advanced cutaneous melanoma in patients who (1)
are not candidates for targeted therapy and (2) are not candidates for an immune checkpoint
inhibitor. Subjects in the comparator arm will receive the Investigator''s choice of
dacarbazine (DTIC), temozolomide (TMZ) or intralesional talimogene laherparepvec as
determined by Investigator preference and standard of care in the Investigator''s country or
region. Effectiveness will be assessed by comparison of progression-free survival (PFS)
between all intent-to-treat (ITT) subjects in the two study treatment arms.
View more details from ClinicalTrials.gov.
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