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 treatment of metastatic castration-resistant prostate cancer
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)
- Patients 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)
- Bone-directed radiotherapy to pelvic region for ease of pain from painful bone metastases is allowed up to 14 days before
Other protocol defined inclusion/exclusion criteria could apply