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

NCT04485949 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2026-02-10

No results posted yet for this 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

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.

Sponsors & Collaborators

  • Imvax

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2026-06-30
Completion
2027-07-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04485949 on ClinicalTrials.gov