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  • NCT06764485

Recruiting

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 - CA071-1000

Opdateret: 9 april, 2025   |   ClinicalTrials.gov

Celgene er et helejet datterselskab af Bristol-Myers Squibb 

Udskriftsvenligt sammendrag

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VÆLG SPROG

Forsøgsdetaljer

  • Phase 3

    Fase

  • Køn

  • 18+

    Aldersinterval

  • 162

    Beliggenhed(er)

  • Recruiting

Behandlingsmuligheder

Forsøgsgrene
TILDELT INTERVENTION
Active Comparator: Part 1: Comparator 1
Drug: Enzalutamide, Abiraterone, Predinsone/Prednisolone
Active Comparator: Part 1: Comparator 2
Drug: Docetaxel, Predinsone/Prednisolone
Experimental: Part 1: Dose 1
Drug: BMS-986365
Experimental: Part 1: Dose 2
Drug: BMS-986365
Active Comparator: Part 2: Comparator 1
Drug: Enzalutamide, Abiraterone, Predinsone/Prednisolone
Active Comparator: Part 2: Comparator 2
Drug: Docetaxel, Predinsone/Prednisolone
Experimental: Part 2: Dose Selected
Drug: BMS-986365

Primære egnethedskriterier

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/Exclusion criteria apply.

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