CTIS2022-502909-15-00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 - CA209650
未提供0 个研究点目标入组 477 人开始时间: 2023年6月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 477
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 65+（—）
- 性别
- Male
入选标准
- •ECOG performance status 0-1, Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI), Ongoing androgen deprivation therapy (ADT) with a Gonadotropinreleasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of =1.73nmol/L (50ng/dL), For crossover phase for participants originally randomized to Arm D3 or Arm D4 only: - Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma of the prostate and evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria (AJCC criteria) prior to randomization
排除标准
- •Presence of visceral metastases in the liver, Active brain metastases or leptomeningeal metastases, Active, known, or suspected autoimmune disease or infection, Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti- CTLA-4 antibody, or any other antibody or drug specifically targeting Tcell co-stimulation or checkpoint pathways., For crossover phase for participants originally randomized to Arm D3 or Arm D4 only: - Prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab., For crossover phase for participants originally randomized to Arm D3 or Arm D4 only: - Have received systemic anti-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel).
研究者
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