A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 Versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Celgene
- 入组人数
- 960
- 试验地点
- 782
- 主要终点
- Radiographic progression-free survival (rPFS) by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) (bone) criteria
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of BMS-986365 versus the investigator's choice of therapy in participants with Metastatic Castration-resistant Prostate Cancer.
详细描述
The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of BMS-986365 versus investigator's choice comprising Docetaxel + Prednisone/Prednisolone or Abiraterone + Prednisone/Prednisolone or Enzalutamide.
In Part 1, participants will be randomized 1:1:1 to one of the two BMS-986365 dose levels, or to the active comparator arm (investigator's choice). In Part 2 of the study, participants will be randomized 1:1 between BMS-986365 selected dose, or to the active comparator arm (investigator's choice).
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
- •Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features.
- •Participants must have current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography/magnetic resonance imaging (CT/MRI).
- •Participants must be asymptomatic or mildly symptomatic from prostate cancer with score on Brief Pain Inventory - Short Form (BPI-SF) that must be <
- •Participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide).
排除标准
- •Participants must not have impaired cardiac function or clinically significant cardiac disease.
- •Participants must not have any brain metastasis.
- •Participants must not have any liver metastasis.
- •Participants with superscan on technetium-99m (Tc-99m) radionuclide bone scans.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Part 1: Comparator 2
干预措施: Docetaxel (Drug)
Part 2: Dose Selected
干预措施: BMS-986365 (Drug)
Part 1: Comparator 1
Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
干预措施: Predinsone/Prednisolone (Drug)
Part 1: Dose 2
干预措施: BMS-986365 (Drug)
Part 1: Comparator 1
Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
干预措施: Abiraterone (Drug)
Part 2: Comparator 1
Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
干预措施: Predinsone/Prednisolone (Drug)
Part 2: Comparator 2
干预措施: Docetaxel (Drug)
Part 1: Comparator 2
干预措施: Predinsone/Prednisolone (Drug)
Part 2: Comparator 2
干预措施: Predinsone/Prednisolone (Drug)
Part 1: Comparator 1
Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
干预措施: Enzalutamide (Drug)
Part 2: Comparator 1
Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
干预措施: Enzalutamide (Drug)
Part 2: Comparator 1
Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
干预措施: Abiraterone (Drug)
Part 1: Dose 1
干预措施: BMS-986365 (Drug)
结局指标
主要结局
Radiographic progression-free survival (rPFS) by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) (bone) criteria
时间窗: Up to 4 years
次要结局
- Confirmed overall response rate (ORR) by BICR assessment in participants with measurable disease using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria(Up to 4 years)
- Time to pain progression (TTPP)(Up to 4 years)
- Overall Survival (OS)(Up to 4 years)
- Recommended dose of BMS-986365 for Part 2(Up to approximately 1.5 years)
- Progression-free survival (PFS)(Up to 4 years)
- Time to symptomatic progression (TTSP)(Up to 4 years)
- Time to initiation of the first subsequent systemic therapy (TFST)(Up to 4 years)
- Prostate-specific antigen (PSA) response rate(Up to 4 years)
- Change from baseline in Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) total scores(Up to 4 years)
- Change from baseline in Prostate Cancer Subscale (PCS) scores(Up to 4 years)
- Change from baseline in trial outcome index (TOI)(Up to 4 years)
- Change from baseline in Brief Pain Inventory - Short Form (BPI-SF) worst pain (item #3) intensity(Up to 4 years)
- Incidence of adverse events (AEs)(Up to 4 years)
- Incidence of serious adverse events (SAEs)(Up to 4 years)
- Incidence of AEs leading to dose modifications(Up to 4 years)
- Incidence of AEs leading to interruptions(Up to 4 years)
- Incidence of AEs leading to discontinuation(Up to 4 years)
- Electrocardiogram (ECG) findings(Up to 4 years)
- Incidence of laboratory abnormalities(Up to 4 years)