Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 diagnosis of malignant glioma based on the treating neurosurgeon’s best clinical judgement defined using the patient’s symptomology, magnetic resonance imaging (MRI) scan results, and intraoperative frozen section verbal confirmation of malignant glioma. Verbal confirmation is defined as the pathologist’s interpretation of the initial result from the flash frozen section during craniotomy and verbally shared with the neurosurgeon as per standard of care (SOC) at the institution.
Note: The definition of GBM (or malignant glioma) has been updated to align with the WHO classification criteria to include diffuse astrocytic glioma, IDH-wildtype, with molecular features of GBM, WHO Grade IV. This would include IDH-wildtype and 1 or more of the following: o Microvascular proliferation; o Necrosis; o Telomerase reverse transcriptase (TERT) promoter mutation; or o Epidermal growth factor receptor (EGFR) amplification.
This would also include diffuse astrocytic glioma, IDH-mutant, WHO Grade IV with any combination of the following: o Microvascular proliferation; o Necrosis; or o Homozygous deletion of cyclin-dependent kinase inhibitor 2A (CDKN2A) and/or cyclin-dependent kinase inhibitor 2B (CDKN2B). Patients are not eligible if the frozen section indicates a diffuse astrocytic glioma with no high-grade features unless a prior needle biopsy (obtained prior to randomization) confirms a molecular WHO Grade IV astrocytic glioma. The Caris report should confirm, not suggest, a molecular Grade IV tumor (i.e., the presence of a TERT promoter mutation).
- 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.
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 (e.g., a cluster of differentiation 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, 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.
- Tests positive for hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or any other active infections that, in the Investigator's opinion, would impair or prohibit a participant's involvement in the study.
- Is receiving treatment with Tumor Treating Fields or Optune®.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 12/12/23. Questions regarding updates should be directed to the study team contact.