A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650)

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

The purpose of this study is to evaluate the effectiveness, safety and tolerability of nivolumab followed by ipilimumab, in subjects with metastatic castration resistant prostate cancer (mCRPC).

Key facts

Study ID

NCT02985957

Run by

Bristol-Myers Squibb

People needed

351

Starts

2017-03-26

Expected to finish

2025-01-07

Last updated by the study team

2025-12-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI).
• 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)
• For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:
• Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma of the prostate and evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria (AJCC criteria) prior to randomization

You may not qualify if…

• Presence of visceral metastases in the liver
• Active brain metastases or leptomeningeal metastases
• Active, known, or suspected autoimmune disease or infection
• Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
• For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:
• Prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab
• Have received systemic anti-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel)
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0046 — Marietta, Georgia, United States
• Local Institution - 0011 — Chicago, Illinois, United States
• Local Institution - 0076 — Minneapolis, Minnesota, United States
• Local Institution - 0008 — St Louis, Missouri, United States
• Local Institution - 0075 — Las Vegas, Nevada, United States
• Local Institution - 0078 — Albany, New York, United States
• Local Institution - 0065 — Lake Success, New York, United States
• Local Institution - 0001 — New York, New York, United States
• Local Institution - 0077 — Tigard, Oregon, United States
• Local Institution - 0047 — Allentown, Pennsylvania, United States
• Local Institution - 0010 — Philadelphia, Pennsylvania, United States
• Local Institution - 0067 — Charleston, South Carolina, United States
• Local Institution - 0079 — Austin, Texas, United States
• Local Institution - 0002 — Houston, Texas, United States
• Local Institution - 0027 — Gosford, New South Wales, Australia
• Local Institution - 0059 — Wahroonga, New South Wales, Australia
• Local Institution - 0029 — Westmead, New South Wales, Australia
• Local Institution - 0028 — Southport, Queensland, Australia
• Local Institution - 0043 — Woolloongabba, Queensland, Australia
• Local Institution - 0030 — Elizabeth Vale, South Australia, Australia
• Local Institution - 0031 — Clayton, Victoria, Australia
• Local Institution - 0048 — Vienna, Austria
• Local Institution - 0044 — Montreal, Quebec, Canada
• Local Institution - 0063 — Aarhus N, Central Jutland, Denmark
• Local Institution - 0074 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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