A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma
Glioblastoma
About this trial
This is an interventional treatment trial for Glioblastoma focused on measuring Newly Diagnosed
Eligibility Criteria
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®
Sites / Locations
- Mayo Clinic - JacksonvilleRecruiting
- Tufts Medical CenterRecruiting
- Henry Ford Health SystemRecruiting
- Dartmouth Hitchcock Medical CenterRecruiting
- Jersey Shore University Medical CenterRecruiting
- Montefiore Medical CenterRecruiting
- Northwell Health at North Shore University HospitalRecruiting
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterRecruiting
- Icahn School of Medicine at Mount SinaiRecruiting
- Columbia University Medical CenterRecruiting
- Weill Cornell MedicineRecruiting
- Lenox Hill HospitalRecruiting
- Westchester Medical CenterRecruiting
- University of North Carolina (UNC) - Chapel HillRecruiting
- UC HealthRecruiting
- The Ohio State University (OSU) Wexner Medical CenterRecruiting
- The Pennsylvania State University (Penn State) Milton S. Hershey Medical CenterRecruiting
- Thomas Jefferson UniversityRecruiting
- University of Pennsylvania
- Rhode Island HospitalRecruiting
- West Virginia UniversityRecruiting
- University of Wisconsin - MadisonRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
IGV-001
Placebo
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).
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).