A Phase 1b/2 Study of PV-10 Intralesional Injection in Combination with Systemic Immune Checkpoint Inhibition for Treatment of Metastatic Melanoma
The goal of this clinical research study is to learn if PV-10 when given in combination with pembrolizumab can help to control metastatic melanoma. The safety of PV-10 will also be studied.
Treatment Location: N/A
Primary Objectives The primary objective of the initial, single-arm Phase 1b portion of the study, is to assess safety and preliminary efficacy (objective response rate (ORR) and progression free survival (PFS)) of the combination (i.e., PV-10 + pembrolizumab) in treating metastatic melanoma. Potential immunomodulatory impact of study treatment will also be assessed. The primary objective of the randomized controlled Phase 2 portion of the study is to assess progression free survival, objective response rate, overall survival and safety of the combination (i.e., PV-10 + pembrolizumab) vs. standard care (i.e., pembrolizumab alone) in treating metastatic melanoma. Efficacy will be assessed by comparison of outcome in all intent-to-treat (ITT) subjects in the two study treatment arms.
IRB Review and Approval Date: 04/26/2016
Recruitment Status: Closed
Projected Accrual: N/A