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A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) in Patients with Solid Tumors (IOV-COM-202)
LN-144 (Lifileucel)/LN-145/LN-145-S1 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process for the treatment of patients with advanced unresectable or metastatic melanoma, advanced squamous cell carcinoma of the head and neck, and non-small cell lung cancer. The adoptive cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphodepletion regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2. Patients in Cohorts 1A, Cohort 2A, and Cohort 3A will receive TIL plus pembrolizumab. Patients in Cohorts 1B and Cohort 3B will receive TIL as a single therapy.
Primary: -To evaluate the efficacy of autologous TIL LN-144/LN-145 in combination with pembrolizumab in MM, HNSCC< or NSCLC patients or TIL LN-145 as a single therapy in relapsed or refractory (r/r) NSCLC patients, who have previously progressed on or after treatment with CPIs, as determined by ORR, using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as assessed by Investigator -To characterize the safety profile of TIL LN-144/LN-145 in combination with pembrolizumab in MM, HNSCC, and NSCLC patients or TIL LN-145 as a single therapy in r/r NSCLC patients as measured by the incidence of Grade ≥3 treatment-emergent adverse events (TEAEs) Secondary: -To further evaluate the efficacy of autologous TIL LN-144/LN-145 in combination with pembrolizumab in MM, HNSCC, and NSCLC patients or TIL LN-145 as a single therapy in NSCLC patients using CR rate, duration of response (DOR), disease control rate (DCR), PFS using RECIST 1.1 as assessed by Investigator, and OR Exploratory: -To explore the persistence of TIL LN-144/LN-145 in combination with pembrolizumab or TIL LN-145 cells as a single therapy, and its resultant immune correlates that may affect response, outcome, and toxicity variables -To explore efficacy parameters (excluding OS) using the immune-related Response Evaluation Criteria in Solid Tumors (irRECIST), as assessed by Investigator -To assess respective, indication-specific, health-related quality-of-life (HRQoL) parameters
BMS-936558 (Nivolumab); IL-2 (Interleukin-2); Ipilimumab (); LN-144 (); LN-145 (); LN-145-S1 (); MESNA (); Nivolumab (Opdivo); Pembrolizumab (Keytruda); TIL (); Yervoy (Ipilimumab); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)