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

The purpose of this study is to determine which combination of Nivolumab plus either Rucaparib, Docetaxel, or Enzalutamide is the most effective in treating Castration-resistant Prostate Cancer that has spread.

Arm A Nivolumab in combination with Rucaparib

Arm B Nivolumab in combination with Docetaxel

Arm C Nivolumab in combination with Enzalutamide

Inclusion Criteria:
• Histologic confirmation of adenocarcinoma of the prostate
• Evidence of metastatic disease
• Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
• Mandatory tumor tissue must be submitted

Exclusion Criteria:
• 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

Other protocol defined inclusion/exclusion criteria could apply.
Phase II
Brendan Curti, M.D.
BMS (Bristol-Myers Squibb)
  • Providence Cancer Institute Franz Clinic