EUCTR2015-002685-23-NL进行中（未招募）1 期
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. - STING (Study of Immunotherapy in Newly Diagnosed Glioblastoma)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 414
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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