A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer

CompletadoFase 2ClinicalTrials.gov

ID: NCT03338790Tipo: INTERVENTIONALInicio: 19 de dic de 2017Fin estimado: 10 de ene de 2025

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Resumen

The purpose of this study is to assess safety and efficacy of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate cancer that has spread.

Elegibilidad

Edad mínima: 18 YearsSexo: MALE

Criterios de inclusión

Histologic confirmation of adenocarcinoma of the prostate
Evidence of stage IV disease on previous bone, CT, and/or MRI scan
Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
Mandatory plasma and fresh or archival tumor tissue must be submitted

Criterios de exclusión

Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast
Participants with active brain metastases
Participants must have recovered from the effects of major surgery requiring general anesthesia or significant traumatic injury at least 14 days before treatment arm assignment