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This investigational combination therapy regimen was developed and evaluated by the H. Lee Moffitt Cancer Center and Research Institute for the treatment of metastatic melanoma. The protocol combines the administration of ipilimumab, a monoclonal antibody that inhibits the cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) checkpoint, with adoptive cell therapy using autologous tumor-infiltrating lymphocytes (TILs). The treatment process typically involves a pre-treatment phase with ipilimumab to enhance the immune environment, followed by surgical tumor harvest for ex vivo TIL expansion. Patients then undergo a lymphodepletion phase using chemotherapy (cyclophosphamide and fludarabine) before receiving the TIL infusion and high-dose interleukin-2 (IL-2) to support T-cell persistence and anti-tumor activity. This multi-modality approach aims to overcome immune suppression and maximize the effector function of tumor-reactive T cells.
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