Phase II Study of LM103 Tumor Infiltrating Lymphocyte Injection Compared to Chemotherapy for Advanced Melanoma in Adults

What this Trial Is About

Researchers are evaluating LM103 tumor infiltrating lymphocyte TIL injection therapy compared to chemotherapy for adults with advanced melanoma who have not responded to at least two prior standard treatments. This phase II trial aims to assess the effects of these treatments on progression-free survival and other outcomes over a 24-month follow-up period. The study involves a total of 92 participants randomly assigned to either the LM103 TILs group or a chemotherapy group. The experimental treatment involves extracting, growing, and expanding TILs from the patients tumor tissue, followed by a non-myeloablative lymphodepletion NMA-LD, infusion of LM103 TILs, and supportive interleukin-2 treatment. The comparison group receives chemotherapy regimens selected by investigators, including drugs like dacarbazine, temozolomide, paclitaxel, and platinum-based agents. Both groups receive treatment according to their assigned arm, with monitoring scheduled throughout the study. Participants will be monitored regularly with assessments every 6 weeks in the first 6 months and every 12 weeks thereafter up to 24 months. These assessments include measuring progression-free survival, overall survival, response rates, disease control, duration of response, and monitoring adverse events. The study involves clinical evaluations, imaging to track tumor lesions, and laboratory tests to ensure safety and effectiveness of the treatments.

A Phase II Trial of LM103 in Advanced Melanoma