Melanoma Clinical Trial
Official title:
Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma
The goal of this clinical research study is to find the recommended dose of OBX-115 in combination with acetazolamide that can be given to patients with metastatic melanoma previously treated with immune checkpoint inhibitors. The safety and tolerability of the study drug combination will also be studied.
Primary Objective: • Assess the safety and tolerability of OBX-115 + acetazolamide by CTCAE version 5 criteria to provide a recommended Phase II dose Secondary Objectives: - Assess preliminary efficacy of OBX-115 + acetazolamide cell therapy in patients with immune checkpoint inhibitor (ICI)-relapsed and/or refractory metastatic melanoma by evaluating overall response rate (ORR; complete response [CR] + partial response [PR]) by RECIST 1.1 criteria - Evaluate feasibility of the manufacturing process - Evaluate duration of response (DOR) - Evaluate progression free survival (PFS) - Characterize in vivo cellular kinetics of OBX-115 cells in tumor and/or in peripheral blood by polymerase chain (PCR) and/or fluorescence-activated cell sorting (FACS) analyses - Characterize the pharmacokinetic profile of acetazolamide when administered in combination with OBX-115 - Characterize the incidence and prevalence of OBX-115 therapy immunogenicity Exploratory Objectives: - Assess relationship of soluble immune factors and pharmacodynamic markers, with cellular kinetics, safety, and efficacy - Describe the composition of OBX-115 subsets (immunophenotyping in peripheral blood mononuclear cells [PBMCs] and in tumor), summarized by clinical response - Explore the correlation of OBX-115 kinetics in tumor and peripheral blood with clinical endpoints - Explore the correlation of immune checkpoints with OBX-115 cellular kinetics and efficacy - Evaluate overall survival (OS) ;
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