Metastatic Castration-resistant Prostate Cancer
Conditions
Keywords
Prostate cancer, Protein degrader, Protein degradation, Androgen receptor, Castrate resistant prostate cancer, Castration resistant prostate cancer, Hormone resistant, Metastatic hormone resistant prostate cancer, Metastatic castrate resistant prostate cancer, Metastatic castration resistant prostate cancer, BMS-986365, CC-94676, CA071-1000, CA0711000, rechARge, Abiraterone, Docetaxel, Enzalutamide
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).
Interventions
DRUGBMS-986365
Specified dose on specified days
DRUGEnzalutamide
Specified dose on specified days
DRUGAbiraterone
Specified dose on specified days
DRUGDocetaxel
Specified dose on specified days
DRUGPredinsone/Prednisolone
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 \< 4. * Participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide).
Exclusion criteria
* 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Argentina, Australia, Austria, Brazil, Canada, Chile, China, Czechia, Denmark, France, Germany, Ireland, Italy, Poland, Puerto Rico, Romania, Slovakia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed