EUCTR2014-001167-12-AT进行中（未招募）1 期
A Phase II Randomized, Double-Blind Trial of Immunotherapy with Nivolumab or Nivolumab plus Ipilimumab versus Double-Placebo Control as a Post-Surgical/Post-Radiation Treatment for Stage IV Melanoma with No Evidence of Disease - Immuned
niversity of Essen0 个研究点目标入组 312 人开始时间: 2017年11月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 312
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.Stage IV melanoma arising from a primary cutaneous site or metastatic from an unknown primary site with no evidence of disease (NED) after surgery or radiation therapy (conducted within 8 weeks before enrolment)
- •2.Signed written informed consent
- •3.Men and women, aged 18 to 80 years
- •4.Known BRAF status
- •5.Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
- •6.Minimum life expectancy of five years excluding their melanoma diagnosis
- •7.ECOG performance status of or 1
- •8.Tumor tissue from the resected site of disease must be provided for biomarker analyses. In order to be randomized a subject must have a PD-L 1 expression classification (positive (= 5% tumor cells expressing PD-L1) or negative (< 5% tumor cells expressing PD-L1)). If an insufficient amount of tumor tissue from the resected site is provided for analysis, acquisition of additional archived tumor tissue (block and/or slides) for the biomarker analyses is required.
- •9.Prior radiotherapy must have been completed at least 2 weeks prior to study drug administration
- •10.Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to randomization:
- •oWBC = 2000/µL
- •oNeutrophils = 1500/µL
- •oPlatelets = 100 x103/µL
- •oHemoglobin = 9.0 g/dL
- •oSerum creatinine = 1.5xUL
- •oCreatinine clearance (CrCl) = 40mL/min if using the Cockcroft-Gault formula
- •11.Negative pregnancy test for female subjects and effective contraception (Pearl-Index <1) for both male and female subjects if the risk of conception exists
- •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 156
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 156
排除标准
- •1.History of primary uveal or mucosal melanoma
- •2.Prior therapy with CTLA4 or PD1 antibodies
- •3.The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
- •4.Lack of availability for clinical follow-up assessments.
- •5.Any immunosuppressive therapy given within the past 30 days prior to study drug administration (excluding physiologic steroid hormone replacement)
- •6.Other malignancies within the past five years requiring treatment except basal or squamous skin carcinomas or carcinoma in situ of the cervix
- •7.Serious cardiac, gastrointestinal, hepatic or pulmonary disease reducing life expectancy to less than five years
- •8.Patients with serious intercurrent illness, requiring hospitalization.
- •9.Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders.
- •10.The patient is known to be positive for Human Immunodeficiency Virus (HIV) or other chronic infections (HBV, HCV).or has another confirmed or suspected immunosuppressive or immunodeficient condition.
- •11.Known hypersensitivity reaction to any of the components of study treatment
- •12.Pregnancy (absence to be confirmed by ß-HCG serum test, minimum sensitivity 25IU/L or equivalent units of HCG)) or lactation period
- •13.Women of childbearing potential (WOCBP): Refusal or inability to use effective means of contraception (Pearl-Index <1). WOCBP receiving Nivolumab will be instructed to adhere to contraception until 31 weeks after the last dose of investigational product
- •14.Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year (Pearl-Index <1). Men receiving Nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception until 31 weeks after the last dose of investigational product
- •15.Known alcohol or drug abuse
- •16.Participation in another clinical study and use of any investigational or non-registered product (drug or vaccine) other than the study treatment within the 30 days before registration
- •17.Significant disease or condition which, in the investigator’s opinion, would exclude the patient from the study
- •18.Legal incapacity or limited legal capacity
研究者
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