A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Safety and Efficacy of IGV-001, an Autologous Cell Immunotherapy With Antisense Oligonucleotide (IMV-001) Targeting IGF-1R, in Newly Diagnosed Patients With Glioblastoma

NCT04485949 Phase 2 ACTIVE_NOT_RECRUITING

The purpose of this study is to assess progression-free survival (PFS) and overall survival (OS) in newly diagnosed Glioblastoma (GBM) participants treated with IGV-001 as compared with placebo.

Details

Lead sponsor	Imvax
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	93
Start date	2023-03-20
Completion	2027-07

Conditions

• Glioblastoma

Interventions

• IGV-001 Cell Immunotherapy
• Placebo
• Standard of Care (SOC): Radiation Therapy
• SOC: Temozolomide

Primary outcomes

• Progression-free Survival (PFS) — Up to 36 months
  PFS is defined as the time from randomization to first progression, as determined by the central radiology review group blinded to the study treatment arm, or death.

Countries

United States