Clinical Trials Search
Clinical Trial 18309
Interventions:Aldesleukin (Interleukin-2); IL-2 (Interleukin-2); Interleukin-2; Proleukin (Interleukin-2); TIL
Study Type: Treatment
Phase of Study: Phase II
- Amod Sarnaik
A Phase 2, Multicenter, Single-arm Study to Assess the Safety, Feasibility, and Efficacy of Cell Transfer Therapy Using Autologous Tumor Infiltrating Lymphocytes (LN-144) Followed by IL-2 for Treatment of 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.