Prostate Cancer
Conditions
Interventions
investigational material(s)
Generic name etc :
INN of investigational material : Nivolumab, Docetaxel, Prednisone
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for
Sponsors
Bristol-Myers Squibb
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Histologic confirmation of adenocarcinoma of the prostate without small cell features Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI) Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy Documented prostate cancer progression per Prostate Cancer Working Group (PCWG3) criteria within 6 months prior to screening Chemotherapy-naive for metastatic castration-resistant prostate cancer (mCRPC), with 1 to 2 prior second generation hormonal therapies in the recurrent non-metastatic setting and/or metastatic setting, and no more than 1 second generation hormonal therapy in the mCRPC setting. Must have progressed during or after second generation hormonal therapy or have documented intolerance to second generation hormonal therapy Participants must meet one of the following criteria regarding tissue submission: Sufficient tumor samples from a newly obtained ("fresh") biopsy (obtained during screening); or archival tumor tissue in the form of formalin-fixed paraffin-embedded (FFPE) block or unstained tumor tissue slides. For participants with bone-only disease or inaccessible soft tissue lesions or if the biopsy procedure would pose an unacceptable clinical risk for the participant, submission of tumor tissue obtained from a fresh biopsy is not required. Men must agree to follow specific methods of contraception, if applicable
Exclusion criteria
Exclusion criteria: Active brain metastases Active, known, or suspected autoimmune disease Condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids or adrenal replacement steroid doses are permitted in the absence of active autoimmune disease Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Prior treatment with docetaxel or other chemotherapy for mCRPC. Prior docetaxel for metastatic castration-sensitive prostate cancer is permitted if at least 12 months have elapsed from last dose of docetaxel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic progression-free survival (rPFS) Overall Survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) Duration of response (DOR) PSA Response Rate (PSA-RR) Time to Response per PCWG3 (TTR-PCWG3) Time to pain progression Time to PSA Progression (TTP-PSA) Incidence of SAEs ( Serious Adverse Events) Incidence of AEs (Adverse Events) | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Contacts
Public ContactYull Arriaga
Bristol-Myers Squibb
Outcome results
None listed