A Phase 3 Randomized, Double Blind, Controlled Study of ICT-107 with Maintenance Temozolomide (TMZ) in Newly Diagnosed Glioblastoma Following Resection and Concomitant TMZ Chemoradiotherapy
Neuroscience - Brain Tumor,
Tara Benkers, MD
ICT-107 consists of dendritic cells, prepared from autologous mononuclear cells that are pulsed with six synthetic peptides that were derived from tumor associated antigens (TAA) present on glioblastoma tumor cells. This is a Phase 3 study to evaluate ICT-107 in patients with newly diagnosed glioblastoma. Subjects will be randomized to receive standard of care chemoradiation (temozolomide (TMZ) with either ICT-107 or a blinded control. Reinfusion with the pulsed dendritic cells should stimulate cytotoxic T cells to specifically target glioblastoma tumour cells.
- Subjects must understand and sign the study specific informed consent
- Subjects must be in primary remission
- Subjects should have < 1 cm3 disease by MRI within the previous 4 weeks (by central read)
- Subjects must be HLA-A2 positive by central lab
- Subjects must have adequate renal, hepatic and bone marrow function based on screening laboratory assessments. Baseline hematologic studies and chemistry and coagulation profiles must meet the following criteria:
a. Hemoglobin (Hgb) > 8 g/dL
b. Absolute Neutrophil Count (ANC) > 1000/mm3
c. Platelet count > 100,000/mm3
d. Blood Urea Nitrogen (BUN) < 30 mg/dL
e. Creatinine < 2 mg/dL
f. Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2 x upper limit of normal (ULN)
g. Prothrombin Time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6x unless therapeutically warranted
- Subjects must use effective contraceptive methods during the study and for three months following the last dose of study product, if of reproductive age and still retain fertility potential.
- Subjects must have at least one positive DTH skin response (more than 5 mm) to test item challenge prior to randomization.
- Subjects receiving investigational study drug for any indication or immunological-based treatment for any reason (Filgrastim may be used for prevention of severe neutropenia).
- Subjects with glioblastoma mutated IDH by Immunohistochemistry (IHC)
- Subjects with concurrent conditions that would jeopardize the safety of the subject or compliance with the protocol.
- Subjects with a history of chronic or acute hepatitis C or B infection.
- Subjects require or are likely to require more than a 2-week course of corticosteroids for intercurrent illness. Subjects must have completed the course of corticosteroids at the time of apheresis to meet eligibility.
- Subjects have any acute infection that requires specific therapy. Acute therapy must have been completed within seven days prior to study enrollment.
- Subjects with active other malignancy diagnosed in the past 3 years (excepting in situ tumors)
- Subjects known to be pregnant or nursing.