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An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer

Trial Status: Active

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

Inclusion Criteria

  • 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

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

Connecticut

New Haven
Yale University
Status: CLOSED_TO_ACCRUAL

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

North Carolina

Durham
Duke University Medical Center
Status: CLOSED_TO_ACCRUAL

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Bristol-Myers Squibb

  • Primary ID CA209-9KD
  • Secondary IDs NCI-2018-00244
  • Clinicaltrials.gov ID NCT03338790