EUCTR2015-002685-23-DE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)
适应症
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 RANO/iRANO for post surgical resection as confirmed by central radiological assessment of MRI with residual tumor < 1 cm x 1 cm on the x and y axes, i.e. tumors = 1cm2 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:
- •a.Hemoglobin (Hgb) > 8 g/dL
- •b.Absolute Neutrophil Count (ANC) = 1.5 x 109/L Platelet count = 100,000/mm3
- •c.Blood Urea Nitrogen (BUN) < 30 mg/dL
- •d.Creatinine < 2 mg/dL
- •e.Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2 x upper limit of normal (ULN)
- •f.Prothrombin Time (PT) and activated partial thromboplastin time (PTT) = 1.6x ULN unless therapeutically warranted
- •6. Subjects must use highly effective contraceptive methods during the study with monthly pregnancy testing 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, B, HIV infection or a positive result upon testing.
- •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, Td, TMZ or dacarbazine
- •11. Patients treated with a live vaccination within the past 4 weeks.
研究者
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