期刊
FUTURE ONCOLOGY
卷 -, 期 -, 页码 -出版社
FUTURE MEDICINE LTD
DOI: 10.2217/fon-2023-0702
关键词
antisense; autologous; glioblastoma; Goldspire (TM); IGV-001; immunotherapy; radiation; temozolomide
类别
This article describes the design and rationale of a randomized, double-blind, phase IIb trial evaluating the efficacy of IGV-001 compared with placebo in patients with ndGBM, followed by standard-of-care treatment. The therapy aims to induce tumor-specific immune response in ndGBM patients.
Standard-of-care first-line therapy for patients with newly diagnosed glioblastoma (ndGBM) is maximal safe surgical resection, then concurrent radiotherapy and temozolomide, followed by maintenance temozolomide. IGV-001, the first product of the Goldspire (TM) platform, is a first-in-class autologous immunotherapeutic product that combines personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001) in implantable biodiffusion chambers, with the intent to induce a tumor-specific immune response in patients with ndGBM. Here, we describe the design and rationale of a randomized, double-blind, phase IIb trial evaluating IGV-001 compared with placebo, both followed by standard-of-care treatment in patients with ndGBM. The primary end point is progression-free survival, and key secondary end points include overall survival and safety.
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