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

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04485949
• Other study ID #: 14379-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 20, 2023
• Est. completion date: July 2027

Study information

• Verified date: May 2024
• Source: Imvax
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 93
• Est. completion date: July 2027
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• Has bi-hemispheric disease, multicentric disease, or disease burden involving the brain stem or cerebellum based on MRI post-gadolinium enhancement

• 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

• 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)

• Has an active cardiac disease or a history of cardiac dysfunction

• 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

• Is partaking in another interventional study. Participants who are partaking in an observational study are eligible

• Has received a live vaccine within 30 days of screening

• 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.

• Is receiving treatment with Tumor Treating Fields or Optune®

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	University of North Carolina (UNC) - Chapel Hill	Chapel Hill	North Carolina
United States	UC Health	Cincinnati	Ohio
United States	The Ohio State University (OSU) Wexner Medical Center	Columbus	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	John Theurer Cancer Center At Hackensack UMC	Hackensack	New Jersey
United States	The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Wisconsin - Madison	Madison	Wisconsin
United States	Northwell Health at North Shore University Hospital	Manhasset	New York
United States	West Virginia University	Morgantown	West Virginia
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Columbia University Medical Center	New York	New York
United States	David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Lenox Hill Hospital	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Westchester Medical Center	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Imvax

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to Deterioration of Karnofsky Performance Status (KPS) Score	Time to KPS deterioration is defined as the time from screening to the first date of deterioration of the KPS score. Deterioration of KPS is defined as a stable or increasing steroid dose-dependent stabilization of a KPS score of <70 over 2 consecutive visits at least 4 weeks apart. KPS is an 11-level score which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks.	Up to 36 months
Other	PFS in Participants With O6-methylguanine-DNA Methyltransferase (MGMT) With Methylation [MGMT+] and MGMT Without Methylation [MGMT-]	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. MGMT status will be determined per epigenetic and tumor proliferation analysis from tissue obtained during surgery.	Up to 36 months
Other	OS in Participants With MGMT+ and MGMT-	OS is defined as the time from randomization to death due to any cause. MGMT status will be determined per epigenetic and tumor proliferation analysis from tissue obtained during surgery.	Up to 48 months
Primary	Progression-free Survival (PFS)	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.	Up to 36 months
Secondary	Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause.	Up to 48 months
Secondary	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Events (ADE), and Unexpected Adverse Device Events (ADR)	An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a product, which does not have a causal relationship with treatment. AEs will be graded according to Common Terminology Criteria for Adverse Events, version 5.0 from mild(Grade 1) to death(Grade 5). SAE is an AE which is considered serious if it results in any of the following outcomes: death, life-threatening AE, require hospitalizations/prolongation of hospitalizations, results in persistent or significant disability; results in a congenital anomaly and is a medically important event. An ADE is defined as any AE caused by or associated with use of a device and suspected to be resulting from insufficiencies in the instructions for use, the deployment, the implantation, the installation, the operation, or any malfunction of the medical device. An Unexpected ADR is defined as an adverse reaction, nature or severity of which is not consistent with product information.	Up to 36 months
Secondary	Number of Participants With Clinically Significant Laboratory Assessment Abnormalities		Up to 36 months
Secondary	Number of Participants With Clinically Significant Vital Signs Measurements		Up to 36 months
Secondary	Number of Participants With Clinically Significant Physical Examination Findings		Up to 36 months