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A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma
Sponsor: Imvax
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
93
Start Date
2023-03-20
Completion Date
2027-07
Last Updated
2026-02-10
Healthy Volunteers
No
Conditions
Interventions
IGV-001 Cell Immunotherapy
IGV-001, an immunotherapeutic product that combines personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001) in implantable biodiffusion chambers.
Placebo
Placebo in implantable biodiffusion chambers containing a predetermined inactive solution.
Standard of Care (SOC): Radiation Therapy
Radiation therapy administered per institutional standards.
SOC: Temozolomide
Temozolomide administered orally.
Locations (23)
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
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
Weill Cornell Medicine
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Westchester Medical Center
Valhalla, New York, United States
University of North Carolina (UNC) - Chapel Hill
Chapel Hill, North Carolina, United States
UC Health
Cincinnati, Ohio, United States
The Ohio State University (OSU) Wexner Medical Center
Columbus, Ohio, United States
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
West Virginia University
Morgantown, West Virginia, United States
University of Wisconsin - Madison
Madison, Wisconsin, United States