NL-OMON45749撤回3 期
STING (Study of Immunotherapy in Newly Diagnosed Glioblastoma): 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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Screening Inclusion Criteria:
- •Subjects may sign informed consent and submit a sampale for HLA typing prior to surgical resection of tumor. Upon receipt of an eligible HLA type resulting (HLA-A2+), tissue should be submitted for determination of MGMT methylation status by the central laboratory, and a post surgical MRI should be submitted for central radiological assessment. These submissions can occur concurrently. Upon receipt of an eligible determination of MRI radiological assessment, a full review of the Inclusion and Exclusion criteria should be completed to determine subject eligibility for enrollment and randomization.;Main study 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 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) > 1500 / 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) * 1.6 x 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 fertillity potential.
- •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.
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 subjects or compliance with the protocol.
- •4. Subjects with a history of chronic or acute hepatitis B, C or HIV infection.
- •5. Subjects require or are likely to require more than a 2-weeks course of corticosteroids for intercurrent illness. Subjects must have completed the course of corticosteriods 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 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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