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ACTIVE NOT RECRUITING Phase 2

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

NCT04485949 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

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

Study Locations (20)

New York

  • Northwell Health at North Shore University Hospital — Manhasset
  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York
  • Icahn School of Medicine at Mount Sinai — New York
  • Columbia University Medical Center — New York
  • Weill Cornell Medicine — New York
  • Lenox Hill Hospital — New York
  • Montefiore Medical Center — The Bronx
  • Westchester Medical Center — Valhalla

Pennsylvania

  • The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center — Hershey
  • Thomas Jefferson University — Philadelphia
  • University of Pennsylvania — Philadelphia

New Jersey

  • John Theurer Cancer Center At Hackensack UMC — Hackensack
  • Jersey Shore University Medical Center — Neptune City

Ohio

  • UC Health — Cincinnati
  • The Ohio State University (OSU) Wexner Medical Center — Columbus

Florida

  • Mayo Clinic - Jacksonville — Jacksonville

Massachusetts

  • Tufts Medical Center — Boston

Michigan

  • Henry Ford Health System — Detroit

New Hampshire

  • Dartmouth Hitchcock Medical Center — Lebanon

Trial Details

FieldValue
Enrollment Target 93 participants
Start Date 2023-03-20
Est. Completion 2027-07
Phase Phase 2

Sponsor

Imvax

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04485949

The ClinicalTrials.gov registry entry for NCT04485949 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Imvax, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 4 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04485949 reports 20 study locations spanning 9 distinct geographic areas — top geographies include New York, Pennsylvania, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04485949 about?

NCT04485949 is a clinical study titled "A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma". 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.

What is the current status of trial NCT04485949?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2023-03-20. Estimated completion is 2027-07.

What conditions does trial NCT04485949 study?

This clinical trial studies the following conditions: Glioblastoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04485949?

The interventions under investigation include: Placebo (COMBINATION_PRODUCT), IGV-001 Cell Immunotherapy (COMBINATION_PRODUCT), Standard of Care (SOC): Radiation Therapy (PROCEDURE), SOC: Temozolomide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04485949?

This trial is sponsored by Imvax, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04485949 being conducted?

This trial has 20 study locations across Florida, Massachusetts, Michigan, New Hampshire, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial