EUCTR2021-003990-74-GR进行中（未招募）1 期
A Phase 2, Open-label, Randomized Controlled Trial of BMS-986218 or BMS-986218 Plus Nivolumab in Combination with Docetaxel in Participants with Metastatic Castration-resistant Prostate Cancer
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
- 204
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
- •Histologic confirmation of carcinoma of the prostate without small cell features.
- •Documented prostate cancer progression by Prostate Cancer Working Group 3 (PCWG3) criteria while castrate.
- •Evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography (CT)/magnetic resonance imaging (MRI).
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- •Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or bilateral orchiectomy (i.e., surgical or medical castration) confirmed by testosterone level = 1.73 nmol/L (50 ng/dL) at the screening visit.
- •Chemotherapy-naive for metastatic castration-resistant prostate cancer (mCRPC) and have received at least one novel antiandrogen therapy (NAT).
- •Other protocol-defined inclusion criteria apply.
- •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 163
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 41
排除标准
- •Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment in Part 1 or randomization in Part 2.
- •Untreated central nervous system (CNS) metastases.
- •Leptomeningeal metastases.
- •Active, known or suspected autoimmune disease.
- •Other protocol-defined exclusion criteria apply.
研究者
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