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Clinical Trial 19122
Interventions:Aldesleukin (Interleukin-2); BMS-936558 (Nivolumab); IL-2 (Interleukin-2); Interleukin-2; Nivolumab; Proleukin (Interleukin-2); TIL; cyclophosphamide; cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
Study Type: Treatment
Phase of Study: Phase I
- Benjamin Creelan
A Phase I Clinical Trial Combining Nivolumab and Tumor Infiltrating Lymphocytes (TIL) for Patients with Advanced Non-Small Cell Lung Cancer
Investigators plan to study the safety, side effects, and benefits of tumor-infiltrating lymphocytes (TILs) when they are given with the drug nivolumab. Nivolumab is a type of immunotherapy - a drug that is used to boost the ability of the immune system to fight cancer, infection, and other diseases.
Primary Objectives: - To evaluate the safety and tolerability of TILs administered following initial progression on nivolumab therapy in combination with nivolumab in subjects with advanced non-small cell lung cancer (NSCLC). Secondary Objectives: - To evaluate the efficacy of TIL administered in combination with nivolumab in subjects with NSCLC by assessing the objective response rate (ORR) per modified RECIST v1.1 (mRECIST v1.1) at the biologically active dose of nivolumab. - To evaluate the efficacy of TIL administered in combination with nivolumab in subjects with NSCLC by assessing duration of response and progression-free survival (PFS). - To evaluate the T-cell persistence following TIL and nivolumab when administered in combination. Exploratory Objectives: - To characterize the pharmacodynamics and evaluate biomarkers of TIL and nivolumab from tumor tissue and peripheral blood. - To explore the antitumor activity of nivolumab in combination with TIL based on immune-related response criteria (irRC). - To evaluate the overall survival (OS) of subjects with select advanced solid tumors treated with TIL administered in combination with nivolumab.