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ACTIVE NOT RECRUITING
NCT04485949
PHASE2

A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma

Sponsor: Imvax

View on ClinicalTrials.gov

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

COMBINATION_PRODUCT

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.

COMBINATION_PRODUCT

Placebo

Placebo in implantable biodiffusion chambers containing a predetermined inactive solution.

PROCEDURE

Standard of Care (SOC): Radiation Therapy

Radiation therapy administered per institutional standards.

DRUG

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