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A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients with Metastatic Melanoma
The purpose of this study is to find out if an investigational product called LN-144 is safe to give to patients with metastatic melanoma and if processing tumors to obtain cells in a central lab works. LN-144 is also called "tumor infiltrating lymphocytes" (TIL).
Primary Objectives: To assess the safety and toxicities associated with the treatment regimen. To assess the feasibility of TIL production, defined as the percentage of patients with tumor resected from which LN-144 is successfully produced (manufacture of more than 1.5 billion viable cells). Secondary Objectives: To assess the feasibility of LN-144 administration followed by IL-2 (defined as the percentage of patients with tumor resected with LN-144 subsequently infused). To evaluate the anti-tumor activity defined by best overall response rate by RECIST 1.1 in patients who receive LN-144 followed by IL-2. Exploratory Objectives: To evaluate additional measures of efficacy for up to 24 months, including: progression-free survival (PFS), overall survival (OS), duration of response, and time to response. To explore potential immune correlates of response, outcome, and toxicity of the treatment.
Patients must meet all of the following inclusion criteria to be eligible for participation in the study.