EUCTR2018-000095-15-GB进行中（未招募）1 期
A Phase II, Open Label, Randomised Study of Ipilimumab With Temozolomide Versus Temozolomide Alone after Surgery and Chemoradiotherapy in Patients with Recently Diagnosed Glioblastoma (IPI-GLIO) - IPI-GLIO: Ipilimumab in Recently 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
- 120
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.Newly diagnosed histologically-confirmed de-novo supratentorial glioblastoma (including gliosarcoma), by WHO guidelines with >20% surgical debulking (surgeon defined).
- •2.Radiotherapy to have begun within 49 days of surgery.
- •3.Completed standard radiotherapy and concurrent temozolomide.
- •4.Clinically appropriate for adjuvant temozolomide and capable of completing adjuvant temozolomide without dose reduction, based on investigator judgement.
- •5.Male or female, age 18-70 years.
- •6.Life expectancy of at least 12 weeks.
- •7.ECOG performance status of 0-1
- •8.The patient is willing and able to comply with the protocol scheduled follow-up visits and examinations for the duration of the study.
- •9.Written (signed and dated) informed consent.
- •10.Haematological and biochemical indices within stated ranges.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 113
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •1. Pregnant or breast-feeding women or women of childbearing potential unless effective methods of contraception are used.
- •2. Multifocal glioblastoma.
- •3. Secondary glioblastoma (i.e. previous histological or radiological diagnosis of lower grade glioma).
- •4. Known extracranial metastatic or leptomeningeal disease.
- •5. Any treatment for glioblastoma other than surgical resection/biopsy and temozolomide chemoradiotherapy.
- •6. Dexamethasone dose >3mg daily (or equivalent) at time of randomisation.
- •7. Intratumoural or peritumoural haemorrhage deemed significant by the treating physician.
- •8. Clinically relevant, active, known or suspected autoimmune disease.
- •9. History of significant gastrointestinal impairment, as judged by the investigator.
- •10. Any evidence of severe or uncontrolled diseases (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
- •11. Known hypersensitivity to trial medications or any of their excipients.
- •12. Past medical history of interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced interstitial disease which required steroid treatment or any evidence of clinically active interstitial lung disease.
- •13. Any condition requiring systemic treatment with corticosteroids (>10mg prednisolone daily or equivalent) or other immunosuppressive medications within 14 days or randomisation. Inhaled or topical steroids, and adrenal replacement steroid doses > 10mg daily prednisolone or equivalent are permitted in the absence of active autoimmune disease.
研究者
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