Details
Description
Inclusion Criteria
Exclusion Criteria
Details
Title STING (Study of Immunotherapy in Newly Diagnosed Glioblastoma): A Phase III randomized double-blind, controlled study of ICT-107 with maintenance temozolomide (TMZ) in newly diagnosed glioblastoma following resection and concomitant TMZ chemoradiotherapy
IRB ICT1315
CC 15-1630
Hospital Main Campus
Phase Phase 3
Disease Brain, Glioblastoma
Drug Temozolomide
Description
Primary Objective- Determine the OS of subjects treated with ICT-107 and standard of care vs. Control and standard of care.
- Determine the OS of subjects with unmethylated MGMT tumors treated with ICT-107 and standard of care vs. control and standard of care;
- Determine the OS of subjects with methylated MGMT tumors treated with ICT-107 and standard of care vs. control and standard of care;
- Evaluate progression-free survival (PFS) of subjects treated with ICT-107 and standard of care vs. control and standard of care; and
- Determine the overall safety of ICT-107 vs. control.
Inclusion Criteria
Screening- Criteria will be assessed after surgical resection of tumor, MRI and tumor assessment and prior to initiation of apheresis and chemoradiation.
- Confirmed Initial Diagnosis of glioblastoma, including documentation of unmutated iso-citrate dehydrogenase (IDH)
- Tissue available for MGMT methylation testing by central testing
- > 18 years of age
- Access to blood for HLA phenotyping
- WHO performance score 0-2
- Subjects must understand and sign the screening informed consent
- 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. At confirmation of eligibility (prior to randomization), residual disease > 1 cm3 is acceptable as long as the total tumor volume is ≤ 25% increase from previous MRI (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:
- Hemoglobin (Hgb) > 8 g/dL
- Absolute Neutrophil Count (ANC) > 1000/mm3
- Platelet count > 100,000/mm3
- Blood Urea Nitrogen (BUN) < 30 mg/dL
- Creatinine < 2 mg/dL
- Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2 x upper limit of normal (ULN)
- 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 (see Section 9.2.3.3 for definition)
- Subjects must have at least one positive DTH skin response (more than 5 mm) to tetanus diphtheria vaccine prior to randomization
Exclusion Criteria
- 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 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 other active malignancy diagnosed in the past 3 years (excepting in situ tumors)
- Subjects known to be pregnant or nursing
- See Section 8.12.1 for excluded therapies
