Phase III (main) study of medicinal product, code ICT-107, along with standard anti-tumour therapy, temozolomide (TMZ), in patients who have newly diagnosed glioblastoma (brain tumour), after surgery along with TMZ and radiation therapy

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 542

Inclusion Criteria

1. Subjects or Legal Authorized Representative (LAR) (varies by region) must understand and sign the study specific informed consent
2. Subjects must be in primary remission
3. Subjects should have non-measureable disease as defined by iRANO for post surgical resection as confirmed by central radiological
assessment of the MRI with residual tumor = 1 cm x 1 cm on the x and y axes, i.e. patients with tumors >1 cm2 will be excluded.
4. Subjects must be HLA-A2 positive by central lab
5. 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) = 1500/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 ULN unless therapeutically warranted
6. 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)
7. Confirmed Initial Diagnosis of glioblastoma, including documentation of unmutated iso-citrate dehydrogenase (IDH)
8. Tissue available for MGMT methylation analysis by central laboratory
9. = 18 years of age
10. WHO performance score 0-2
11. Subjects must understand and sign the informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 434
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 108

Exclusion Criteria

1. Subjects receiving investigational study drug for any indication or immunological-based treatment for any reason (Filgrastim may be used
for prevention of severe neutropenia).
2. Subjects with glioblastoma mutated IDH by Immunohistochemistry (IHC)
3. Subjects with concurrent conditions that would jeopardize the safety of the subject or compliance with the protocol.
4. Subjects with a history of chronic or acute hepatitis C or B or HIV infection.
5. 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.
6. Subjects have any acute infection that requires specific intravenous (IV) therapy. Acute IV therapy must have been completed within seven
days prior to study enrollment.
7. Subjects with active malignancy diagnosed in the past 3 years (excepting in situ tumors)
8. Subjects known to be pregnant or nursing.
9. See Section 8.12.1 for excluded therapies.
10. Patients with hypersensitivity towards a known constituent of the study therapy, TMZ or dacarbazine
11. Patients treated with a live vaccination within the past 4 weeks.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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