NCT02906605撤回2 期
An Open-label, Randomized, Phase 2 Study of the Clinical Activity and Safety of JNJ-64041809, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Apalutamide Versus Apalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Time to Prostate-specific Antigen (PSA) Progression
研究概览
简要总结
The purpose of this study is to evaluate if the anti-tumor activity of JNJ-809 combined with apalutamide is improved compared with apalutamide alone for subjects with metastatic castration-resistant prostate cancer (mCRPC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adenocarcinoma of the prostate
- •Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans
- •Surgically or medically castrated, with testosterone levels of less than (<)50 nanogram per deciliter (ng/dL)
- •Castration-resistant prostate cancer documented by time to prostate-specific antigen (PSA) increase during continuous treatment with androgen deprivation therapy (ADT) OR radiographic progression of soft tissues OR radiographic progression of bone according to PCWG3
排除标准
- •Predominately small cell or neuroendocrine carcinoma of the prostate
- •Known brain metastases (even if treated) or untreated epidural spread
- •Prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting, or up to 6 cycles of docetaxel for metastatic hormone-sensitive prostate cancer
- •Treatment with medications known to lower the seizure threshold or any investigational agent that were not discontinued or substituted greater than or equal to (>=)28 days prior to randomization
研究组 & 干预措施
JNJ-809 plus Apalutamide (Group A)
Experimental
JNJ-809 given as an infusion and Apalutamide 240 milligram (mg) daily.
干预措施: JNJ-809 (Drug)
JNJ-809 plus Apalutamide (Group A)
Experimental
JNJ-809 given as an infusion and Apalutamide 240 milligram (mg) daily.
干预措施: Apalutamide (Drug)
Apalutamide (Group B)
Experimental
Apalutamide 240 mg orally daily.
干预措施: Apalutamide (Drug)
结局指标
主要结局
Time to Prostate-specific Antigen (PSA) Progression
时间窗: approximately 2 years
Time to PSA progression will be measured using Prostate Cancer Working Group 3 (PCWG3).
次要结局
- Blood Culture and Shedding Profile of JNJ-809 From Cultured Samples of Feces, Urine, and Saliva(approximately 2 years)
- Overall Survival(approximately 2 years)
- Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability(approximately 2 years)
- PSA Doubling Time (PSADT)(approximately 2 years)
- Time to Unequivocal Clinical Progression(approximately 2 years)
- Radiographic Progression-free Survival(approximately 2 years)
研究者
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