A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, 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.
18 Years and up
Accepting Healthy Volunteers?
- 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
- 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.
Other protocol defined inclusion/exclusion criteria could apply