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
- Conditions
- Treatment of newly diagnosed glioblastomaMedDRA version: 19.0Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-002685-23-NL
- Lead Sponsor
- ImmunoCellular Therapeutics, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 414
Screening Inclusion Criteria:
• Confirmed Initial Diagnosis of glioblastoma, including unmutated iso-citrate dehydrogenase (IDH)
• Glioblastoma tissue available for MGMT methylation testing by central lab.
• > 18 years of age
• Access to blood for HLA phenotyping
• WHO performance score 0-2
• Subjects must understand and sign the screening informed consent
Main study inclusions
1. Subjects must understand and sign the study specific informed consent
2. Subjects must be in primary remission
3. Subjects should have < 1 cm3 disease by MRI within the previous 4 weeks as defined by iRANO (by central read)
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:
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
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.
7. Subjects must have at least one positive DTH skin response (more than 5 mm) to test item challenge prior to randomization.
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 328
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 86
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 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 therapy. Acute 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
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