Clinical trial NCT04485949: A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Glioblastoma
Keywords: Newly Diagnosed
Lead sponsor: Imvax
Sponsor class: INDUSTRY
First posted: 2020-07-24
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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®

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to 36 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 48 months
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Events (ADE), and Unexpected Adverse Device Events (ADR)
timeFrame: Up to 36 months
measure: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
timeFrame: Up to 36 months
measure: Number of Participants With Clinically Significant Vital Signs Measurements
timeFrame: Up to 36 months
measure: Number of Participants With Clinically Significant Physical Examination Findings
timeFrame: Up to 36 months
Other outcomes:
measure: Time to Deterioration of Karnofsky Performance Status (KPS) Score
timeFrame: Up to 36 months
measure: PFS in Participants With O6-methylguanine-DNA Methyltransferase (MGMT) With Methylation [MGMT+] and MGMT Without Methylation [MGMT-]
timeFrame: Up to 36 months
measure: OS in Participants With MGMT+ and MGMT-
timeFrame: Up to 48 months
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Hackensack
country: United States
facility: John Theurer Cancer Center At Hackensack UMC
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Manhasset
country: United States
facility: Northwell Health at North Shore University Hospital
state: New York
city: New York
country: United States
facility: David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina (UNC) - Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: UC Health
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University (OSU) Wexner Medical Center
state: Ohio
city: Hershey
country: United States
facility: The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
References: