Brief 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.
Brief Title
A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Glioblastoma
Eligibility Criteria
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®
* 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®
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
Newly Diagnosed
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
70 Years
Minimum Age
18 Years
NCT Id
NCT04485949
Org Class
Industry
Org Full Name
Imvax
Org Study Id
14379-201
Overall Status
Active, not recruiting
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome Description
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.
Outcome Measure
Progression-free Survival (PFS)
Outcome Time Frame
Up to 36 months
Secondary Outcomes
Outcome Description
OS is defined as the time from randomization to death due to any cause.
Outcome Time Frame
Up to 48 months
Outcome Measure
Overall Survival (OS)
Outcome Description
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.
Outcome Time Frame
Up to 36 months
Outcome Measure
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Events (ADE), and Unexpected Adverse Device Events (ADR)
Outcome Time Frame
Up to 36 months
Outcome Measure
Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Outcome Time Frame
Up to 36 months
Outcome Measure
Number of Participants With Clinically Significant Vital Signs Measurements
Outcome Time Frame
Up to 36 months
Outcome Measure
Number of Participants With Clinically Significant Physical Examination Findings
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
70
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Vijay Agarwal
Investigator Email
vagarwal@montefiore.org
Investigator Phone
310-413-4338