Study of Nivolumab Plus Ipilimumab, Ipilimumab or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer
Trial Status: Active
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.
- 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.
University of Chicago Comprehensive Cancer Center
Siteman Cancer Center at Washington University
Icahn School of Medicine at Mount Sinai
University of Pennsylvania / Abramson Cancer Center
M D Anderson Cancer Center
Trial Phase Phase II
Trial Type Treatment
- Primary ID CA209-650
- Secondary IDs NCI-2017-01488, 2016-001928-54
- Clinicaltrials.gov ID NCT02985957