Study of Nivolumab Plus Ipilimumab, Ipilimumab or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to determine whether Nivolumab plus Ipilimumab has preliminary evidence of safety and effectiveness in the treatment of participants with metastatic castration-resistant prostate cancer who have progressed after prior Docetaxel-containing regimen.

Inclusion Criteria

• Evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria) on previous bone, CT and/or MRI scan.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of ≤1.73nmol/L (50ng/dL)
• Participants with skeletal system symptoms who are already on medications to strengthen bones are allowed if they were started ˃28 days before study treatment

Exclusion Criteria

• Cancer that has spread to the liver or brain
• Active, known, or suspected autoimmune disease or infection
• Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
• Prior whole pelvic radiotherapy, or radiotherapy to >30% of bone marrow. Bone-directed radiotherapy for palliation of painful bone metastases to pelvic region is allowed up to 14 days before treatment assignment.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Bristol-Myers Squibb

• Primary ID CA209-650
• Secondary IDs NCI-2017-01488, 2016-001928-54
• Clinicaltrials.gov ID NCT02985957