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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04485949
Recruitment Status : Not yet recruiting
First Posted : July 24, 2020
Last Update Posted : June 29, 2022
Sponsor:
Information provided by (Responsible Party):
Imvax

Brief Summary:
The purpose of this study is to assess progression-free survival (PFS) and overall survival (OS) in newly diagnosed Glioblastoma multiforme (GBM) participants treated with IGV-001 as compared with placebo.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Glioblastoma Biological: IGV-001 Cell Immunotherapy Biological: Placebo Procedure: Standard of Care (SOC): Radiation Therapy Drug: SOC: Temozolomide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 - the ImmuneSense Study
Estimated Study Start Date : December 2022
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IGV-001
Participants will be implanted with biodiffusion chambers containing IGV-001 on Day 1 and explanted with IGV-001 on Day 3 (at approximately 48 hours of 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).
Biological: IGV-001 Cell Immunotherapy
IGV-001, containing autologous GBM cells treated with antisense oligonucleotide (IMV-001), encapsulated in biodiffusion chambers.

Procedure: Standard of Care (SOC): Radiation Therapy
Radiation therapy administered per institutional standards.

Drug: SOC: Temozolomide
Temozolomide administered orally.

Placebo Comparator: Placebo
Participants will be implanted with biodiffusion chambers containing placebo on Day 1 and explanted with placebo on Day 3 (at approximately 48 hours of 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).
Biological: Placebo
Placebo, encapsulated in 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.




Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: Up to 36 months ]
    PFS is defined as the time from randomization to event or censoring, as determined by the independent central radiology review group blinded to the study treatment arm.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 48 months ]
    OS is defined as the time from randomization to death due to any cause.

  2. Time to Deterioration of Karnofsky Performance Status (KPS) Score [ Time Frame: Up to 48 months ]
    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.

  3. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 36 months ]
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 from mild (Grade 1) to death (Grade 5). SAE is an AE or adverse reaction which is considered serious if it results in any of the following outcomes: death, life-threatening AE, require hospitalizations or prolongation of hospitalizations, results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect and is a medically important event.

  4. Number of Participants With Clinically Significant Laboratory Assessment Abnormalities [ Time Frame: Up to 36 months ]
  5. Number of Participants With Clinically Significant Vital Signs Measurements [ Time Frame: Up to 36 months ]
  6. Number of Participants With Clinically Significant Physical Examination Findings [ Time Frame: Up to 36 months ]

Other Outcome Measures:
  1. PFS at 6 Months After Randomization (PFS6) [ Time Frame: Up to 6 months ]
    PFS6 is defined as the time from randomization to event or censoring for up to 6 months after randomization.

  2. PFS in Participants With O6-methylguanine-DNA Methyltransferase (MGMT) With Methylation [MGMT+] and MGMT Without Methylation [MGMT-] [ Time Frame: Up to 36 months ]
    PFS is defined as the time from randomization to event or censoring. MGMT status will be determined per epigenetic analysis from tissue obtained during surgery.

  3. OS in Participants With MGMT+ and MGMT- [ Time Frame: Up to 48 months ]
    OS is defined as the time from randomization to death due to any cause. MGMT status will be determined per epigenetic analysis from tissue obtained during surgery.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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®

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04485949


Contacts
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Contact: Madhavi Diwanji +1 2679004110 contact@imvax.com
Contact: Kirsten Lees

Locations
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Sponsors and Collaborators
Imvax
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Responsible Party: Imvax
ClinicalTrials.gov Identifier: NCT04485949    
Other Study ID Numbers: 14379-201
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: June 29, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents