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

Primary Purpose

Glioblastoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IGV-001 Cell Immunotherapy
Placebo
Standard of Care (SOC): Radiation Therapy
SOC: Temozolomide
Sponsored by
Imvax
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Newly Diagnosed

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Has a Karnofsky performance scale (KPS) score ≥ 70 at screening
  • Has a 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 (as assessed by the adapted Response Assessment in Neuro-Oncology [RANO] criteria) 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
  • Tests positive for at least 1 antigen for Candida or trichophyton from the anergy panel at screening
  • 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 GBM
  • Has recurrent 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, 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), human immunodeficiency virus (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®

Sites / Locations

  • Mayo Clinic - JacksonvilleRecruiting
  • Tufts Medical CenterRecruiting
  • Henry Ford Health SystemRecruiting
  • Dartmouth Hitchcock Medical CenterRecruiting
  • Jersey Shore University Medical CenterRecruiting
  • Montefiore Medical CenterRecruiting
  • Northwell Health at North Shore University HospitalRecruiting
  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting
  • Columbia University Medical CenterRecruiting
  • Weill Cornell MedicineRecruiting
  • Lenox Hill HospitalRecruiting
  • Westchester Medical CenterRecruiting
  • University of North Carolina (UNC) - Chapel HillRecruiting
  • UC HealthRecruiting
  • The Ohio State University (OSU) Wexner Medical CenterRecruiting
  • The Pennsylvania State University (Penn State) Milton S. Hershey Medical CenterRecruiting
  • Thomas Jefferson UniversityRecruiting
  • University of Pennsylvania
  • Rhode Island HospitalRecruiting
  • West Virginia UniversityRecruiting
  • University of Wisconsin - MadisonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IGV-001

Placebo

Arm Description

Participants will be implanted with biodiffusion chambers containing IGV-001 on Day 1 and explanted on Day 3 (at approximately 48 hours following implantation). After 6 weeks, participants will receive radiotherapy (RT) per institutional standards for 5 days per week along with temozolomide 75 mg/m^2 orally, once daily (QD) for up to 12 weeks followed by temozolomide 150 to 200 mg/m^2, orally, on Days 1 to 5 of each 28-day cycle for up to 6 cycles (Week 41).

Participants will be implanted with biodiffusion chambers containing placebo on Day 1 and explanted on Day 3 (at approximately 48 hours following implantation). After 6 weeks, participants will receive RT per institutional standards for 5 days per week along with temozolomide 75 mg/m^2 orally, QD for up to 12 weeks followed by temozolomide 150 to 200 mg/m^2, orally, on Days 1 to 5 of each 28-day cycle for up to 6 cycles (Week 41).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
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.
Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Number of Participants With Clinically Significant Vital Signs Measurements
Number of Participants With Clinically Significant Physical Examination Findings

Full Information

First Posted
July 22, 2020
Last Updated
October 17, 2023
Sponsor
Imvax
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1. Study Identification

Unique Protocol Identification Number
NCT04485949
Brief Title
A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imvax

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
Newly Diagnosed

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
93 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IGV-001
Arm Type
Experimental
Arm Description
Participants will be implanted with biodiffusion chambers containing IGV-001 on Day 1 and explanted on Day 3 (at approximately 48 hours following implantation). After 6 weeks, participants will receive radiotherapy (RT) per institutional standards for 5 days per week along with temozolomide 75 mg/m^2 orally, once daily (QD) for up to 12 weeks followed by temozolomide 150 to 200 mg/m^2, orally, on Days 1 to 5 of each 28-day cycle for up to 6 cycles (Week 41).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be implanted with biodiffusion chambers containing placebo on Day 1 and explanted on Day 3 (at approximately 48 hours following implantation). After 6 weeks, participants will receive RT per institutional standards for 5 days per week along with temozolomide 75 mg/m^2 orally, QD for up to 12 weeks followed by temozolomide 150 to 200 mg/m^2, orally, on Days 1 to 5 of each 28-day cycle for up to 6 cycles (Week 41).
Intervention Type
Combination Product
Intervention Name(s)
IGV-001 Cell Immunotherapy
Intervention Description
IGV-001, an immunotherapeutic product that combines personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001) in implantable biodiffusion chambers.
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
Placebo in implantable biodiffusion chambers containing a predetermined inactive solution.
Intervention Type
Procedure
Intervention Name(s)
Standard of Care (SOC): Radiation Therapy
Intervention Description
Radiation therapy administered per institutional standards.
Intervention Type
Drug
Intervention Name(s)
SOC: Temozolomide
Intervention Description
Temozolomide administered orally.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
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.
Time Frame
Up to 36 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to 48 months
Title
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Events (ADE), and Unexpected Adverse Device Events (ADR)
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.
Time Frame
Up to 36 months
Title
Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Time Frame
Up to 36 months
Title
Number of Participants With Clinically Significant Vital Signs Measurements
Time Frame
Up to 36 months
Title
Number of Participants With Clinically Significant Physical Examination Findings
Time Frame
Up to 36 months
Other Pre-specified Outcome Measures:
Title
Time to Deterioration of Karnofsky Performance Status (KPS) Score
Description
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.
Time Frame
Up to 36 months
Title
PFS in Participants With O6-methylguanine-DNA Methyltransferase (MGMT) With Methylation [MGMT+] and MGMT Without Methylation [MGMT-]
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. MGMT status will be determined per epigenetic and tumor proliferation analysis from tissue obtained during surgery.
Time Frame
Up to 36 months
Title
OS in Participants With MGMT+ and MGMT-
Description
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.
Time Frame
Up to 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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®
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madhavi Diwanji
Phone
+1 2679004110
Email
contact@imvax.com; m.diwanji@imvax.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Krause
Email
j.krause@imvax.com
Facility Information:
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfredo Quinones-Hinojosa
Phone
904-956-3435
Email
Quinones-Hinojosa.Alfredo@mayo.edu
First Name & Middle Initial & Last Name & Degree
Alfredo Quinones-Hinojosa
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julian Wu
Phone
617-636-4500
Email
jwu3@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name & Degree
Julian Wu
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Lee
Phone
313-916-1340
Email
ILEE1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Ian Lee
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linton Evans
Phone
603-715-0358
Email
Linton.T.Evans@hitchcock.org
First Name & Middle Initial & Last Name & Degree
Linton Evans
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Correia
Email
carloseduardo.silvacorreia@hmhn.org
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vijay Agarwal
Phone
310-413-4338
Email
vagarwal@montefiore.org
First Name & Middle Initial & Last Name & Degree
Vijay Agarwal
Facility Name
Northwell Health at North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Schulder
Phone
516-941-1260
Email
mschulder@northwell.edu
First Name & Middle Initial & Last Name & Degree
Michael Schulder
Facility Name
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cameron Brenan
Phone
212-639-2848
Email
brennac2@mskcc.org
First Name & Middle Initial & Last Name & Degree
Cameron Brennan
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Lyndon
Phone
212-824-8579
Email
lyndon.kim@mssm.edu
First Name & Middle Initial & Last Name & Degree
Kim Lyndon
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Gill
Phone
216-212-1545
Email
bjg2140@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Brian Gill
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rohan Ramakrishna
Phone
212-746-1996
Email
ror9068@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Rohan Ramakrishna
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Boockvar
Phone
212-746-1996
Email
jboockvar@northwell.edu
First Name & Middle Initial & Last Name & Degree
John Boockvar
Facility Name
Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Hanft
Phone
914-493-2363
Email
Simon.Hanft@wmchealth.org
First Name & Middle Initial & Last Name & Degree
Simon Hanft
Facility Name
University of North Carolina (UNC) - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasmeen Rauf
Email
raufy@email.unc.edu
First Name & Middle Initial & Last Name & Degree
Yasmeen Rauf
Facility Name
UC Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Zuccarello
Phone
513-475-8990
Email
zuccarm@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Mario Zuccarello
Facility Name
The Ohio State University (OSU) Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brad Elder
Phone
614-685-1965
Email
James.Elder@osumc.edu
First Name & Middle Initial & Last Name & Degree
Brad Elder
Facility Name
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brad Zacharia
Phone
717-531-8807
Email
bzacharia@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name & Degree
Brad Zacharia
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Judy
Phone
215-503-0524
Email
Kevin.Judy@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Kevin Judy
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19130
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nduka Amankulor
Phone
215-316-5151
Email
amankuln@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Nduka Amankulor
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Wong
Phone
401-444-0115
Email
EWong1@lifespan.org
First Name & Middle Initial & Last Name & Degree
Eric Wong
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonikpreet Aulakh
Phone
304-293-3489
Email
Sonikpreet.aulakh@hsc.wvu.edu
First Name & Middle Initial & Last Name & Degree
Sonikpreet Aulakh
Facility Name
University of Wisconsin - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ankush Bhatia
Phone
281-319-8530
Email
bhatia@neurology.wisc.edu
First Name & Middle Initial & Last Name & Degree
Ankush Bhatia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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