Clinical Trials Search
Clinical Trial 19381
Interventions:DTIC (Dacarbazine); Dacarbazine; Not Applicable; PV-10; Talimogene Laherparepvec (OncoVEX); Talimogene laherparepvec 10^6 PFU (Talimogene Laherparepvec); Talimogene laherparepvec 10^8 PFU (Talimogene Laherparepvec); Temodal (Temozolomide); Temozolomide
Study Type: Treatment
Phase of Study: Phase III
- Jonathan Zager
PV-10 Intralesional Injection vs Systemic Chemotherapy or Intralesional Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
The purpose of this study is to see if an investigational drug called PV-10 can help people with melanoma.
Primary Objective: The primary objective of this randomized controlled trial (RCT) is to assess the effectiveness of intralesional (IL) PV-10 compared to the Investigators choice of systemic chemotherapy or intralesional oncolytic viral therapy in treating locally advanced cutaneous melanoma. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms. Secondary Objectives: This study will also include assessment and comparison of the two study treatment arms with respect to: Complete response rate (CRR). Duration of complete response. Overall survival (OS). Safety and tolerability.