This is a Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study, with the objective of comparing Progression-Free Survival (PFS) in newly diagnosed GBM patients treated with IGV-001 with patients treated with placebo.
The ImmuneSense Study
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 – The ImmuneSense Study
Glioblastoma
All genders
18-70
Recruiting now
Overview
Principal Investigator: Julian Wu, MD
Contact Us
Christian Lawlor
Study details
Inclusion Criteria
- Has a Karnofsky Performance Scale (KPS) score at least 70 at screening
- Has a histologically proven diagnosis of GBM (World Health Organization [WHO] Grade IV) from tumor tissue obtained at time of craniotomy and resection on Day -2
- Has a diagnosis of malignant glioma based on the treating neurosurgeon’s best clinical judgement
Exclusion Criteria
- Has bi-hemispheric disease, multifocal disease, or multicentric disease, or disease burden involving the brain stem or cerebellum based on MRI post-gadolinium enhancement
- Has received any previous surgical resection or any anticancer intervention for GBM. Note: Patients who received prior biopsy are eligible as long as a post-biopsy MRI scan is available and they meet all other eligibility criteria
- Has recurrent glioma, a concurrent malignancy, or malignancy within 3 years of randomization, unless definitive therapy is completed, with the exception of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast that has completed curative therapy
Study Requirements
The study periods are comprised of the following 4 periods:
- Screening Period: from the day of signing the informed consent form (up to 14 days prior to randomization) to the time of randomization;
- Treatment Period: from the time of randomization to the day before the first day of SOC therapy at Week 7, Day 49 (1 week);
- Standard of Care Treatment Period: from the first day of starting SOC therapy until the last day of the TMZ maintenance cycle, including 6 weeks of RT and TMZ combination therapy and, 4 weeks later, six 28-day cycles of oral TMZ maintenance therapy (totaling approximately 34 weeks or 8 months); and
- Follow-Up Period: from the day after SOC treatment or early termination (ET) to 36 months after randomization.
Eligible patients will be randomized in a 2:1 ratio to receive either IGV-001 treatment (approximately 62 patients) or placebo (approximately 31 patients).