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

NCT04485949 | Active Not Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: 14379-201
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 23

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.

Conditions

Glioblastoma

Keywords

Newly Diagnosed

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 36 months

Secondary Outcomes (5)

• Overall Survival (OS)

  Up to 48 months

• Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Events (ADE), and Unexpected Adverse Device Events (ADR)

  Up to 36 months

• 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 Outcomes (3)

• Time to Deterioration of Karnofsky Performance Status (KPS) Score

  Up to 36 months

• PFS in Participants With O6-methylguanine-DNA Methyltransferase (MGMT) With Methylation [MGMT+] and MGMT Without Methylation [MGMT-]

  Up to 36 months

• OS in Participants With MGMT+ and MGMT-

  Up to 48 months

Study Arms (2)

IGV-001

EXPERIMENTAL

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).

Combination Product: IGV-001 Cell Immunotherapy; Procedure: Standard of Care (SOC): Radiation Therapy; Drug: SOC: Temozolomide

Placebo

PLACEBO COMPARATOR

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).

Combination Product: Placebo; Procedure: Standard of Care (SOC): Radiation Therapy; Drug: SOC: Temozolomide

Interventions

Placebo COMBINATION_PRODUCT

Placebo in implantable biodiffusion chambers containing a predetermined inactive solution.

Placebo

IGV-001 Cell Immunotherapy COMBINATION_PRODUCT

IGV-001, an immunotherapeutic product that combines personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001) in implantable biodiffusion chambers.

IGV-001

Standard of Care (SOC): Radiation Therapy PROCEDURE

Radiation therapy administered per institutional standards.

IGV-001; Placebo

SOC: Temozolomide DRUG

Temozolomide administered orally.

IGV-001; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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®

Sponsors & Collaborators

• Imvax: lead

Study Sites (23)

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

John Theurer Cancer Center At Hackensack UMC

Hackensack, New Jersey, 07601, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Northwell Health at North Shore University Hospital

Manhasset, New York, 11030, United States

Location

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Westchester Medical Center

Valhalla, New York, 10595, United States

Location

University of North Carolina (UNC) - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

UC Health

Cincinnati, Ohio, 45229, United States

Location

The Ohio State University (OSU) Wexner Medical Center

Columbus, Ohio, 43201, United States

Location

The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19130, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Location

Related Publications (2)

• Lee IY, Hanft S, Schulder M, Judy KD, Wong ET, Elder JB, Evans LT, Zuccarello M, Wu J, Aulakh S, Agarwal V, Ramakrishna R, Gill BJ, Quinones-Hinojosa A, Brennan C, Zacharia BE, Silva Correia CE, Diwanji M, Pennock GK, Scott C, Perez-Olle R, Andrews DW, Boockvar JA. Autologous cell immunotherapy (IGV-001) with IGF-1R antisense oligonucleotide in newly diagnosed glioblastoma patients. Future Oncol. 2024 Mar;20(10):579-591. doi: 10.2217/fon-2023-0702. Epub 2023 Dec 7.

  PMID: 38060340 DERIVED

• Andrews CE, Zilberberg J, Perez-Olle R, Exley MA, Andrews DW. Targeted immunotherapy for glioblastoma involving whole tumor-derived autologous cells in the upfront setting after craniotomy. J Neurooncol. 2023 Dec;165(3):389-398. doi: 10.1007/s11060-023-04491-4. Epub 2023 Nov 29.

  PMID: 38017340 DERIVED

MeSH Terms

Conditions

Glioblastoma

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 24, 2020
• Study Start: March 20, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)