A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 292
- 试验地点
- 66
- 主要终点
- Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3)
研究概览
简要总结
The purpose of this study is to assess safety and efficacy of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate cancer that has spread.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Histologic confirmation of adenocarcinoma of the prostate
- •Evidence of stage IV disease on previous bone, CT, and/or MRI scan
- •Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
- •Mandatory plasma and fresh or archival tumor tissue must be submitted
排除标准
- •Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast
- •Participants with active brain metastases
- •Participants must have recovered from the effects of major surgery requiring general anesthesia or significant traumatic injury at least 14 days before treatment arm assignment
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
nivolumab + rucaparib
Specified dose on specified days
干预措施: nivolumab (Biological)
nivolumab + rucaparib
Specified dose on specified days
干预措施: rucaparib (Drug)
nivolumab + docetaxel + prednisone
Specified dose on specified days
干预措施: nivolumab (Biological)
nivolumab + docetaxel + prednisone
Specified dose on specified days
干预措施: docetaxel (Drug)
nivolumab + docetaxel + prednisone
Specified dose on specified days
干预措施: prednisone (Drug)
nivolumab + enzalutamide
Specified dose on specified days
干预措施: nivolumab (Biological)
nivolumab + enzalutamide
Specified dose on specified days
干预措施: enzalutamide (Drug)
结局指标
主要结局
Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3)
时间窗: Up to approximately 36 months
Objective response rate per prostate cancer clinical trials working group 3 (ORR-PCWG3) for target lesions and assessed by MRI is the percentage of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among treated participants who have measurable disease
Prostate-Specific Antigen Response Rate (RR-PSA)
时间窗: Up to approximately 36 months
Prostate-specific antigen response rate (RR-PSA) is the percentage of treated participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result
次要结局
- Radiographic Progression-Free Survival (rPFS)(Up to approximately 84 months)
- Time to Response Per Prostate Cancer Clinical Trials Working Group 3 (TTR-PCWG3)(Up to approximately 84 months)
- Duration of Response Per Prostate Cancer Clinical Trials Working Group 3 (DOR-PCWG3)(Up to approximately 84 months)
- Prostate-Specific Antigen Time to Progression (TTP-PSA)(Up to approximately 84 months)
- Overall Survival (OS)(Up to approximately 84 months)
- Number of Participants With Adverse Events (AEs)(From first dose to up to 30 days post last dose (Up to 82 months))
- Number of Participants Who Died(Up to 84 months)
- Number of Participants With Laboratory Abnormalities in Specific Liver Tests(From first dose to up to 30 days post last dose (up to 82 months))
- Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests(From first dose to up to 30 days post last dose (Up to 82 months))
- Number of Participants With Laboratory Values Change From Baseline(From first dose to up to 30 days post last dose (Up to 82 months))