Trials / Active Not Recruiting
Active Not RecruitingNCT04485949
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
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 93 (estimated)
- Sponsor
- Imvax · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-03-20
- Primary completion
- 2026-06-01
- Completion
- 2027-07-01
- First posted
- 2020-07-24
- Last updated
- 2026-02-10
Locations
23 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04485949. Inclusion in this directory is not an endorsement.