A Randomized, Multicenter, Double-Blind, Placebo-Controlled,Phase 2b Study to Assess the Safety and Efficacy of IGV-001, anAutologous Cell Immunotherapy With Antisense Oligonucleotide (IMV-001) Targeting IGF-1R, in Newly Diagnosed Patients With Glioblastoma the ImmuneSense Study
Objective
Primary Objectives: The primary objective is to compare Progression-Free Survival (PFS) in newly diagnosed GBM patients treated with IGV-001 with patients treated with placebo.
Secondary: The secondary objectives are to compare patients treated with IGV-001 with patients treated with placebo for the following: Overall Survival (OS); PFS at 6 months (PFS6); PFS, OS, and PFS6 within subgroups of patients (O6-methylguanine-DNA methyltransferase [MGMT] methylated [MGMT+] and O6-methylguanine-DNA methyltransferase unmethylated [MGMT]); PFS, OS, and PFS6 within the subgroup of patients with histologic confirmation of World Health Organization (WHO) Grade III (diffuse astrocytic glioma, isocitrate dehydrogenase [IDH]-wildtype, with molecular features of glioblastoma, WHO Grade IV) or WHO Grade IV GBM; Time to deterioration of Karnofsky Performance Scale (KPS) score; and To determine safety and tolerability of IGV-001 in newly diagnosed GBM patients.
Exploratory: The exploratory objectives are to compare patients treated with IGV-001 with patients treated withplacebo for the following: Change in quality of life (QOL); Immune response markers; Response Rate in patients who have measurable residual disease after surgery; and Tumor mutational burden.
