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BMS-986365

Phase 3

Metastatic Castration-resistant Prostate Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: May 6, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment960
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06764485A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate CancerPHASE3 RECRUITING 960Mar 13, 2025Jan 19, 2029May 6, 2026282 United States, Argentina +24
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Study Endpoints
Primary Endpoints
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 Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1: Dose 1EXPERIMENTAL -
Part 1: Dose 2EXPERIMENTAL -
Part 1: Comparator 1ACTIVE_COMPARATOREnzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
Part 1: Comparator 2ACTIVE_COMPARATOR -
Part 2: Dose SelectedEXPERIMENTAL -
Part 2: Comparator 1ACTIVE_COMPARATOREnzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
Part 2: Comparator 2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
BMS-986365DRUGSpecified dose on specified days
EnzalutamideDRUGSpecified dose on specified days
AbirateroneDRUGSpecified dose on specified days
DocetaxelDRUGSpecified dose on specified days
Predinsone/PrednisoloneDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites282

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 ...

Countries:United StatesArgentinaAustraliaAustriaBrazilCanadaChileChinaCzechiaDenmarkFranceGermanyIndiaIrelandItalyJapanPolandPuerto RicoRomaniaSlovakiaSouth KoreaSpainSwedenTaiwanTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06764485primaryCompletionDate: changed
LOWMay 24, 2026NCT06764485studyFirstPostDate: changed