EUCTR2013-002408-15-NO进行中（未招募）不适用
Phase IV ipilimumab in melanoma A National, Multicenter, Interventional Study in Patients with Unresectable or Metastatic Melanoma
Oslo University Hospital0 个研究点开始时间: 2013年10月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Histologically or cytologically confirmed diagnosis of malignant melanoma
- •Previously-treated unresectable Stage III or Stage IV melanoma (AJCC 2010)
- •Prior adjuvant melanoma therapy is permitted; any number of previous treatments for melanoma are permitted.
- •ECOG performance status of 0 or 1.
- •Men and women = 18 years of age
- •Adequate hematologic, renal and hepatic function, specifically:
- •- WBC = 2500/uL
- •- Absolute neutrophil count (ANC) = 1000/uL
- •- Platelets = 75 x 103/uL
- •- Hemoglobin = 9 g/dL
- •- Creatinine = 2.5 x ULN
- •- AST/ALT = 3 x ULN for subjects without liver metastasis; = 5 x ULN for subjects with liver metastasis
- •- Total bilirubin = 3 x ULN, (except subjects with Gilbert’s Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
- •Women of childbearing potential (WOCBP) and men must be using an acceptable method as described in section 7.2 to prevent pregnancy.
- •Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (eg, Guillain-Barre syndrome). Patients with vitiligo is NOT excluded.
- •MRI detected active brain metastatis wich require other therapies such as surgery and/or radio therapy. Patients already treated for their brain metastasis, surgery or radio therapy, and have had stable desease for more than two month and NOT requiring steroids may however be includet in this trial.
- •Uncontrolled infectious diseases – requires negative tests for clinically suspected HIV, HBV and HCV. If positive results are not indicative of true active or chronic infection, the subject may enter the study after discussion and agreement between the Investigator and the Medical Monitor.
- •History of or current immunodeficiency disease, splenectomy or splenic irradiation
- •Prior allogeneic stem cell transplantation
- •Women who are breastfeeding
- •Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea
- •History of allergic reaction to parenteral administered recombinant protein product
- •Any reason why, in the opinion of the investigator, the patient should not participate.
研究者
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