A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer

CompletadoFase 3ClinicalTrials.gov

ID: NCT04100018Tipo: INTERVENTIONALInicio: 6 de feb de 2020Fin estimado: 25 de jun de 2024

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to assess the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation.

Elegibilidad

Edad mínima: 18 YearsSexo: MALE

Criterios de inclusión

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-naïve 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

Criterios de exclusión

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

Intervenciones

biological

Nivolumab

Specified dose on specified days

drug

Prednisone

Specified dose on specified days

drug

Docetaxel

Specified dose on specified days

other

Placebo

Specified dose on specified days

Ubicaciones

Local Institution - 0129

Mar del Plata, Buenos Aires, Argentina

Local Institution - 0061

Pergamino, Buenos Aires, Argentina

Local Institution - 0153

Parana, Córdoba Province, Argentina

Local Institution - 0393

Río Cuarto, Córdoba Province, Argentina

Local Institution - 0083

Viedma, Río Negro Province, Argentina

Local Institution - 0077

Buenos Aires, Argentina

Local Institution - 0178

Buenos Aires, Argentina

Local Institution - 0185

Buenos Aires, Argentina

Local Institution - 0369

La Rioja, Argentina

Local Institution - 0394

San Juan, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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