Treatment of newly diagnosed glioblastoma MedDRA version: 19.1 Level: PT Classification code 10018337 Term: Glioblastoma multiforme System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: ICT-107
Product Code: ICT-107
Pharmaceutical Form: Dispersion for injection
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: ICT-107
Other descriptive name: Peptide-loaded de
Sponsors
ImmunoCellular Therapeutics, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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) =65 years) yes F.1.3.1 Number of subjects for this age range 108
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To determine the OS of subjects with unmethylated MGMT tumours treated with ICT-107 and standard of care vs. control and standard of care. To determine the OS of subjects with methylated MGMT tumours treated with ICT-107 and standard of care vs. control and standard of care. To evaluate progression-free survival (PFS) of subjects treated with ICT-107 and standard of care vs. control and standard of care. To determine the overall safey of ICT-107 vs. control. ;Primary end point(s): The primary endpoint is overall survival (OS), which will be analyzed after 387 deaths have been observed, of subjects treated with ICT-107 and standard of care (RT and TMZ) vs. placebo control and standard of care (RT and TMZ);Timepoint(s) of evaluation of this end point: The primary endpoint is overall survival (OS), which will be analyzed after 387 deaths have been observed;Main Objective: To determine the overall survival (OS) of subjects treated with ICT-107 and standard of care (radiotherapy (RT)and Temozolomide (TMZ)) vs. placebo control and standard of care (RT and TMZ) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To determine the OS of subjects with unmethylated MGMT tumors treated with ICT-107 and standard of care vs. control and standard of care • To determine the OS of subjects with methylated MGMT tumors treated with ICT-107 and standard of care vs. control and standard of care. • To evaluate progression-free survival (PFS) of subjects treated with ICT-107 and standard of care vs. control and standard of care • To determine the overall safety of ICT-107 vs. control;Timepoint(s) of evaluation of this end point: Final Evaluation on all endpoints at 46 months Secondary Endpoint: 1 and 2: OS at 6, 9, 12 months, and every 3 months after until study completion. 3: Progression-free-survival (PFS) is determined based on patient having disease progression (PD). If preliminary diagnosis of PD is made at any time, follow up in 2 months to confirm. In the first cycle tumour assessments take place week 3, then cycles 2, 4, 6, 8, 10, 12, 14, 16, 18, 20 and 22. 4: - Overall safety assessed during Induction Phase on day of injection (weekly for 4 weeks), every 2 weeks during Maintenance Phase (Weeks 1 and 3 during Cycles 1 – 11), monthly during Extended Maintenance Phase (Cycles 12 -23). Also at time of PD confirmation and End of Study visit. Additionally, at any other time an adverse event reported. | — |
Countries
Austria, Canada, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactImmunoCellular Clinical Trials
ImmunoCellular Therapeutics, Ltd
Outcome results
None listed