Clinical Trials Search
Clinical Trial 18377
Interventions:Aldesleukin (Interleukin-2); BMS-936558 (Nivolumab); IL-2 (Interleukin-2); Interleukin-2; Nivolumab; Proleukin (Interleukin-2); TIL
Study Type: Treatment
Phase of Study: Pilot
- Amod Sarnaik
A Pilot Clinical Trial Combining PD-1 Blockade, CD137 Agonism and Adoptive Cell Therapy for Metastatic Melanoma
The purpose of this study is to investigate 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.
The primary objectives of this study will be: 1. To determine the safety of the combination of the PD-1 antibody, nivolumab, with adoptive cell therapy using cells grown with CD137 antibody in patients with unresectable metastatic melanoma. 2. To establish the feasibility of the combination treatment, as shown by the ability to successfully treat >= 67% of patients (i.e., at least 5 of 6 if 6 patients are accrued to a given cohort) with adoptive cell therapy without defined DLT accrued to any cohort of the trial. 3. To determine the recommended phase 2 scheduling of PD-1 antibody nivolumab when combined with adoptive cell therapy. The secondary objectives of this study will be: 1. To determine the objective response rate associated with the treatment regimen. 2. To determine the progression-free and overall survival associated with the treatment regimen. 3. To measure the infiltration of T cells into tumors after PD-1 antibody treatment, and to determine TIL persistence after adoptive cell therapy combined with PD-1 antibody treatment.