EUCTR2015-002685-23-AT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)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 542
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
- •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
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 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.
研究者
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