EUCTR2016-001928-54-ES进行中（未招募）1 期
A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 495
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
- Male
入选标准
- •- Men, 18 years or older with histologic confirmation of adenocarcinoma of the prostate and evidence of
- •Stage IV disease (defined by AJCC)
- •-ECOG performance status 0-1
- •-Ongoing androgen deprivation therapy (ADT) with a GnRH analogue or a surgical/medical castration with testosterone level of =1.73nmol/L (50ng/dL)
- •-Patients with skeletal system symptoms who are already on medications to strengthen bones are allowed if they were started ?28 days before enrollment
- •-Bone-directed radiotherapy to pelvic region for ease of pain from painful bone metastases is allowed up to 14 days before
- •-Sufficient fresh or archival tumor tissue obtained within 5 years prior to enrollment from a metastatic tumor lesion or from a primary tumor lesion that has not been previously irradiated (formalin-fixed paraffin-embedded [FFPE] block or unstained tumor tissue sections).
- •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 198
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 297
排除标准
- •-Cancer that has spread to the liver or brain
- •-Active, known, or suspected autoimmune disease or infection
- •-Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
研究者
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