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  • NCT02985957

Active, Not Recruiting

A Study to Evaluate Preliminary Safety and Efficacy of Nivolumab Plus Ipilimumab in Men With Metastatic Castration-Resistant Prostate Cancer - CA209-650

Oppdatert: 5 januar, 2024   |   ClinicalTrials.gov

Utskriftsvennlig Sammendrag

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  • Phase 2

    Fase

  • Kjønn

  • 18+

    Aldersgruppe

  • Active, Not Recruiting

Behandlingsalternativer

Studiearmer
TILDELT INTERVENSJON
Experimental: Cohort D (Arm D1)
Biological: Nivolumab, Ipilimumab
Experimental: Cohort D (Arm D2)
Biological: Nivolumab, Ipilimumab
Experimental: Cohort D (Arm D3)
Biological: Ipilimumab
Experimental: Cohort D (Arm D4)
Drug: Cabazitaxel, Prednisone
Experimental: Cytotoxic Chemotherapy
Biological: Nivolumab, Ipilimumab
Experimental: Immunotherapy regimens (Cohort D)
Biological: Nivolumab, Ipilimumab
Experimental: Second Generation Hormone Therapies
Biological: Nivolumab, Ipilimumab

Nøkkelkriterier for kvalifikasjon

For more information regarding Bristol Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Metastatic, castrate resistant prostate cancer (M1 by National Comprehensive Cancer Network (NCCN) criteria) - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of ≤1.73nmol/L (50ng/dL) - Patients with skeletal system symptoms who are already on medications to strengthen bones are allowed if they were started ˃28 days before study treatment - Bone-directed radiotherapy to pelvic region for ease of pain from painful bone metastases is allowed up to 14 days before Exclusion Criteria: - Cancer that has spread to the liver or brain - Active, known, or suspected autoimmune disease or infection - Prior treatment with any drug that targets T cell co-stimulation pathways(such as checkpoint inhibitors) Other protocol defined inclusion/exclusion criteria could apply

Vi anbefaler at du kontakter BMS for å rapportere bivirkninger.
Bivirkninger (uønskede hendelser) og andre rapporterbare hendelser er definert her
For å rapportere bivirkninger (uønskede hendelser) eller reklamere på et legemiddel: Medisinsk informasjon

MLTNO2000046