A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma
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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 |
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Recruitment Status :
Recruiting
First Posted : July 24, 2020
Last Update Posted : March 5, 2024
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Sponsor:
Imvax
Information provided by (Responsible Party):
Imvax
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Glioblastoma | Combination Product: IGV-001 Cell Immunotherapy Combination Product: Placebo Procedure: Standard of Care (SOC): Radiation Therapy Drug: SOC: Temozolomide | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 93 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel 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 |
| Actual Study Start Date : | March 20, 2023 |
| Estimated Primary Completion Date : | January 2025 |
| Estimated Study Completion Date : | July 2027 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: IGV-001
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).
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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. Procedure: Standard of Care (SOC): Radiation Therapy Radiation therapy administered per institutional standards. Drug: SOC: Temozolomide Temozolomide administered orally. |
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Placebo Comparator: Placebo
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).
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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. |
Primary Outcome Measures :
- Progression-free Survival (PFS) [ Time Frame: Up to 36 months ]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) [ Time Frame: Up to 48 months ]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) [ Time Frame: Up to 36 months ]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 [ Time Frame: Up to 36 months ]
- Number of Participants With Clinically Significant Vital Signs Measurements [ Time Frame: Up to 36 months ]
- Number of Participants With Clinically Significant Physical Examination Findings [ Time Frame: Up to 36 months ]
Other Outcome Measures:
- Time to Deterioration of Karnofsky Performance Status (KPS) Score [ Time Frame: Up to 36 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.
- 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 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.
- 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 and tumor proliferation analysis from tissue obtained during surgery.
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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 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®
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
| Contact: Madhavi Diwanji | +1 2679004110 | contact@imvax.com; m.diwanji@imvax.com | |
| Contact: Jill Krause | j.krause@imvax.com |
Locations
Show 23 study locations
Sponsors and Collaborators
Imvax
| Responsible Party: | Imvax |
| ClinicalTrials.gov Identifier: | NCT04485949 |
| Other Study ID Numbers: |
14379-201 |
| First Posted: | July 24, 2020 Key Record Dates |
| Last Update Posted: | March 5, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
Keywords provided by Imvax:
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Newly Diagnosed |
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 |