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

Sponsor

Imvax (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04485949

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2027

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Progression-free Survival (PFS) [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

Overall Survival (OS) [Up to 48 months]
OS is defined as the time from randomization to death due to any cause.
Time to Deterioration of Karnofsky Performance Status (KPS) Score [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.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [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.
Number of Participants With Clinically Significant Laboratory Assessment Abnormalities [Up to 36 months]
Number of Participants With Clinically Significant Vital Signs Measurements [Up to 36 months]
Number of Participants With Clinically Significant Physical Examination Findings [Up to 36 months]

Other Outcome Measures

PFS at 6 Months After Randomization (PFS6) [Up to 6 months]
PFS6 is defined as the time from randomization to event or censoring for up to 6 months after randomization.
PFS in Participants With O6-methylguanine-DNA Methyltransferase (MGMT) With Methylation [MGMT+] and MGMT Without Methylation [MGMT-] [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.
OS in Participants With MGMT+ and MGMT- [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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®

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ChristianaCare Helen F. Graham Cancer Center and Research Institute	Newark	Delaware	United States	19713
2	Mayo Clinic - Jacksonville	Jacksonville	Florida	United States	32224
3	Piedmont Healthcare	Atlanta	Georgia	United States	30318
4	Tufts Medical Center	Boston	Massachusetts	United States	02111
5	Henry Ford Health System	Detroit	Michigan	United States	48202
6	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
7	John Theurer Cancer Center At Hackensack UMC	Hackensack	New Jersey	United States	07601
8	Montefiore Medical Center	Bronx	New York	United States	10467
9	Northwell Health at North Shore University Hospital	Manhasset	New York	United States	11030
10	David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center	New York	New York	United States	10021
11	Columbia University Medical Center	New York	New York	United States	10032
12	Weill Cornell Medicine	New York	New York	United States	10065
13	Lenox Hill Hospital	New York	New York	United States	10075
14	Wake Forest	Winston-Salem	North Carolina	United States	27157
15	UC Health	Cincinnati	Ohio	United States	45229
16	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
17	The Ohio State University (OSU) Wexner Medical Center	Columbus	Ohio	United States	43201
18	The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
19	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
20	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19130
21	Rhode Island Hospital	Providence	Rhode Island	United States	02903
22	West Virginia University	Morgantown	West Virginia	United States	26506
23	University of Wisconsin - Madison	Madison	Wisconsin	United States	53705

Sponsors and Collaborators

Imvax

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Imvax

ClinicalTrials.gov Identifier:

NCT04485949

Other Study ID Numbers:

14379-201

First Posted:

Jul 24, 2020

Last Update Posted:

Jun 29, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Glioblastoma

Temozolomide

Study Results

No Results Posted as of Jun 29, 2022