A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma
- Conditions
- Glioblastoma
- Interventions
- Combination Product: IGV-001 Cell ImmunotherapyCombination Product: Placebo
- Registration Number
- NCT04485949
- Lead Sponsor
- Imvax
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 93
- 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
- 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®
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IGV-001 IGV-001 Cell Immunotherapy 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). Placebo 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).
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) 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
Name Time Method Number of Participants With Clinically Significant Vital Signs Measurements Up to 36 months Number of Participants With Clinically Significant Laboratory Assessment Abnormalities Up to 36 months Overall Survival (OS) Up to 48 months OS is defined as the time from randomization to death due to any cause.
Number of Participants With Clinically Significant Physical Examination Findings Up to 36 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 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.
Trial Locations
- Locations (23)
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
John Theurer Cancer Center At Hackensack UMC
🇺🇸Hackensack, New Jersey, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
UC Health
🇺🇸Cincinnati, Ohio, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Northwell Health at North Shore University Hospital
🇺🇸Manhasset, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
The Ohio State University (OSU) Wexner Medical Center
🇺🇸Columbus, Ohio, United States
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
University of North Carolina (UNC) - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
University of Wisconsin - Madison
🇺🇸Madison, Wisconsin, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States