A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer
- Conditions
- Metastatic Castration-resistant Prostate Cancer
- Interventions
- Registration Number
- NCT06764485
- Lead Sponsor
- Celgene
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 960
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Dose 2 BMS-986365 - Part 1: Comparator 1 Enzalutamide Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone Part 1: Comparator 1 Abiraterone Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone Part 1: Comparator 1 Predinsone/Prednisolone Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone Part 1: Comparator 2 Docetaxel - Part 1: Comparator 2 Predinsone/Prednisolone - Part 2: Comparator 1 Enzalutamide Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone Part 2: Comparator 1 Abiraterone Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone Part 2: Comparator 1 Predinsone/Prednisolone Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone Part 2: Comparator 2 Docetaxel - Part 2: Comparator 2 Predinsone/Prednisolone - Part 1: Dose 1 BMS-986365 - Part 2: Dose Selected BMS-986365 -
- Primary Outcome Measures
Name Time Method 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 Up to 4 years
- Secondary Outcome Measures
Name Time Method 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 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 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 ECG Findings defined as :
* Number of Postbaseline Abnormal Corrected QT (QTc) Values
* Number of abnormal Beats Per Minute (BPM)Incidence of laboratory abnormalities Up to 4 years
Related Research Topics
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Trial Locations
- Locations (258)
Lakeland Regional Cancer Center
🇺🇸Lakeland, Florida, United States
Philadelphia Veterans Affairs Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Cetus Oncologia - Unidade Belo Horizonte
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Liga Norte Riograndense Contra o Câncer
🇧🇷Natal, Rio Grande do Norte, Brazil
A. C. Camargo Cancer Center
🇧🇷São Paulo, São Paulo, Brazil
Oncocentro Valdivia
🇨🇱Valdivia, Los Ríos Region, Chile
The First Affiliated hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
The First People's Hospital of Changzhou
🇨🇳Changzhou, Jiangsu, China
Sichuan Cancer hospital
🇨🇳Chengdu, Sichuan, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Scroll for more (248 remaining)Lakeland Regional Cancer Center🇺🇸Lakeland, Florida, United StatesPeter Hinds, Site 0426Contact412-573-9554