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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 30
- 主要终点
- Number of Participants With Treatment Related Adverse Events
研究概览
简要总结
The purpose of this study is to assess the safety, efficacy, tolerability, and toxicity of docetaxel alone, in combination with BMS-986218, or in combination with nivolumab plus BMS-986218 in men who have metastatic castration-resistant prostate cancer (mCRPC) that progressed after novel antiandrogen therapy and have not received chemotherapy for mCRPC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 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)
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 inclusion/exclusion criteria apply
研究组 & 干预措施
Arm 1A: Docetaxel + BMS-986218
干预措施: BMS-986218 (Biological)
Arm 1A: Docetaxel + BMS-986218
干预措施: Docetaxel (Drug)
Arm 2B: Docetaxel + BMS-986218
干预措施: BMS-986218 (Biological)
Arm 1B: Docetaxel + BMS-986218 + Nivolumab
干预措施: BMS-986218 (Biological)
Arm 1B: Docetaxel + BMS-986218 + Nivolumab
干预措施: Docetaxel (Drug)
Arm 1B: Docetaxel + BMS-986218 + Nivolumab
干预措施: Nivolumab (Biological)
Arm 2A: Docetaxel
干预措施: Docetaxel (Drug)
Arm 2B: Docetaxel + BMS-986218
干预措施: Docetaxel (Drug)
Arm 2C: Docetaxel + BMS-986218 + Nivolumab
干预措施: BMS-986218 (Biological)
Arm 2C: Docetaxel + BMS-986218 + Nivolumab
干预措施: Docetaxel (Drug)
Arm 2C: Docetaxel + BMS-986218 + Nivolumab
干预措施: Nivolumab (Biological)
Arm 2D (Optional Crossover): BMS-986218 + Nivolumab
干预措施: BMS-986218 (Biological)
Arm 2D (Optional Crossover): BMS-986218 + Nivolumab
干预措施: Nivolumab (Biological)
结局指标
主要结局
Number of Participants With Treatment Related Adverse Events
时间窗: From first dose to 100 days follow up to last dose (Approximately 22 months)
Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
Number of Participants With Treatment Related Serious Adverse Events
时间窗: From first dose to 100 days follow up to last dose (Approximately 22 months)
Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
Number of Participants With Dose Limiting Toxicities
时间窗: From first dose to 100 days follow up to last dose (Approximately 22 months)
DLTs will be defined as: Any treatment-related AEs for which a participant permanently discontinues a study treatment (other than daily prednisone) and that occurs during the first 2 cycles of treatment. Any death not clearly due to the underlying disease or extraneous causes and that occurs during the first 2 cycles of treatment Greater than or equal to Grade 2 pneumonitis lasting greater than 5 days despite appropriate medical therapy and that occurs during the first 2 cycles of treatment Any neutropenic fever as well as Grade 4 neutropenia or thrombocytopenia for \> 7 days that occurs during the first 2 cycles of treatment Any treatment-related AE that delays initiation of Cycle 2 or Cycle 3 of treatment by greater than 2 consecutive weeks.
Number of Participants With AEs Leading to Discontinuation
时间窗: From first dose to 100 days follow up to last dose (Approximately 22 months)
Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
Number of Participants Who Died
时间窗: From first dose to 100 days follow up to last dose (Approximately 22 months)
Number of participant deaths
次要结局
- Prostate Specific Antigen Response Rate (PSA-RR)(From first dose to 100 days follow up to last dose (Approximately 22 months))
- Objective Response Rate(From first dose to 100 days follow up to last dose (Approximately 22 months))
- Time to Response(From first dose to 100 days follow up to last dose (Approximately 22 months))
- Duration of Response(From first dose to 100 days follow up to last dose (Approximately 22 months))
- Overall Survival(From first dose to 100 days follow up to last dose (Approximately 22 months))