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NCT04485949 · ClinicalTrials.gov registry record · Phase 2
A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma
A Phase 2 study of Glioblastoma, sponsored by Imvax.
- Active
- Registry status
- Phase 2
- Development phase
- 93
- Enrollment target
- 20
- Study locations
NCT04485949: Active Phase 2 study of Glioblastoma, sponsored by Imvax.
NCT04485949 is a Phase 2 study of Glioblastoma that is active but no longer recruiting, run by Imvax. The registered enrollment target is 93 participants, below the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (14% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04485949, a Phase 2 study of Glioblastoma, is active but no longer recruiting, sponsored by Imvax.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 93 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2023-03-20 |
| Est. Completion | 2027-07 |
| Phase | Phase 2 |
What the registry record for NCT04485949 still lists
NCT04485949 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (14% lower).
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.
NCT04485949 names 20 study sites across 9 states, led by New York, Pennsylvania, New Jersey.
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.
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).
Who is sponsoring clinical trial NCT04485949?
This trial is sponsored by Imvax, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04485949's enrollment target sits among peer trials
93 50th of 199 higher than 150 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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