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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
99
IGV-001, an immunotherapeutic product that combines personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001) in implantable biodiffusion chambers.
Placebo in implantable biodiffusion chambers containing a predetermined inactive solution.
Radiation therapy administered per institutional standards.
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Progression-free Survival (PFS)
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.
Time frame: Up to 36 months
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to 48 months
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Events (ADE), and Unexpected Adverse Device Events (ADR)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a product, which does not have a causal relationship with treatment. AEs will be graded according to Common Terminology Criteria for Adverse Events, version 5.0 from mild(Grade 1) to death(Grade 5). SAE is an AE which is considered serious if it results in any of the following outcomes: death, life-threatening AE, require hospitalizations/prolongation of hospitalizations, results in persistent or significant disability; results in a congenital anomaly and is a medically important event. An ADE is defined as any AE caused by or associated with use of a device and suspected to be resulting from insufficiencies in the instructions for use, the deployment, the implantation, the installation, the operation, or any malfunction of the medical device. An Unexpected ADR is defined as an adverse reaction, nature or severity of which is not consistent with product information.
Time frame: Up to 36 months
Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Time frame: Up to 36 months
Number of Participants With Clinically Significant Vital Signs Measurements
Time frame: Up to 36 months
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Temozolomide administered orally.
Tufts Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
John Theurer Cancer Center At Hackensack UMC
Hackensack, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Northwell Health at North Shore University Hospital
Manhasset, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
...and 13 more locations
Number of Participants With Clinically Significant Physical Examination Findings
Time frame: Up to 36 months