NCT04485949Active, not recruitingPhase 2
A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma
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
Source: ClinicalTrials.gov · Last updated 9 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 99 (actual)
- First submitted
- 22 Jul 2020
- Start date
- 20 Mar 2023
- Primary completion date
- Jan 2027
- Lead sponsor
- Imvax
- Diseases
- Glioblastoma
- NCT number
- NCT04485949
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 99
- From 20 Mar 2023 to the primary completion date, Jan 2027
- 23 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received any previous surgical resection or any anticancer intervention for glioma
- Has any history of glioma, a concurrent malignancy, or malignancy within 3 years of randomization, unless definitive therapy is completed, with the exception of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast that has completed curative therapy
- Is receiving any other investigational agent(s) or has received an investigational agent within 30 days or 5 half-lives of investigational agent use, whichever is longer, prior to screening
- Has received a live vaccine within 30 days of screening
- Is receiving treatment with Tumor Treating Fields or Optune®
Other illness
- Has bi-hemispheric disease, multicentric disease, or disease burden involving the brain stem or cerebellum based on MRI post-gadolinium enhancement
- Has an active cardiac disease or a history of cardiac dysfunction
- Has active and uncontrolled/untreated hepatitis B virus (HBV), hepatitis C virus (HCV), HIV, or any other active infections that, in the Investigator's opinion, would impair or prohibit a participant's participation in this study.
Lab values
- Has any severe immunocompromised condition (eg, human immunodeficiency virus (HIV) with a cluster of differentiation \[CD\] 4+ cell count \<200\*10\^6/liter \[L\]) or any active uncontrolled autoimmune disease (eg, Crohn's disease)
Other
- Is partaking in another interventional study. Participants who are partaking in an observational study are eligible
Who the study is looking for
- Has a Karnofsky performance scale (KPS) score ≥ 70 at screening
- Has a new diagnosis of GBM (WHO GRADE III or Grade IV GBM) based on the treating neurosurgeon's best clinical judgement
- Has a diagnostic contrast-enhanced magnetic resonance imaging (MRI) scan with fluid attenuated inversion-recovery (FLAIR) sequence of the brain at screening. Participants must have a confirmed measurable disease pre-operatively with at least 1 lesion measuring a total bi-perpendicular product of 4 centimeter square (cm\^2) in 2 different planes (axial, sagittal, or coronal)
- The tumor must be located in the supratentorial compartment
- Has adequate bone marrow and organ function at screening
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tufts Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of North Carolina (UNC) - Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| UC Health Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| The Ohio State University (OSU) Wexner Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| John Theurer Cancer Center At Hackensack UMC Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Mayo Clinic- Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
| University of Wisconsin - Madison Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Northwell Health at North Shore University Hospital Coordinator of this site? Confirm its status | Manhasset | United States | Unknown status |
| West Virginia University Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| Jersey Shore University Medical Center Coordinator of this site? Confirm its status | Neptune City | United States | Unknown status |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Lenox Hill Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Rhode Island Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Westchester Medical Center Coordinator of this site? Confirm its status | Valhalla | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.