A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650)
NCT ID: NCT02985957
Last Updated: 2025-12-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
351 participants
INTERVENTIONAL
2017-03-26
2025-01-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A (Arm A)
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Cohort B (Arm B)
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Cohort C (Arm C)
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Cohort D (Arm D1)
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Cohort D (Arm D2)
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Cohort D (Arm D3)
Ipilimumab
Specified dose on specified days
Cohort D (Arm D4)
Cabazitaxel
Specified dose on specified days
Prednisone
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Cabazitaxel
Specified dose on specified days
Prednisone
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
MALE
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0074
Tucson, Arizona, United States
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 - 0062
Aalborg, , Denmark
Local Institution - 0061
København Ø, , Denmark
Local Institution - 0060
Odense, , Denmark
Local Institution - 0009
Clermont-Ferrand, , France
Local Institution - 0005
Lyon, , France
Local Institution - 0004
Marseille, , France
Local Institution - 0003
Villejuif, , France
Local Institution - 0038
Göttingen, Lower Saxony, Germany
Local Institution - 0041
Braunschweig, , Germany
Local Institution - 0032
Dresden, , Germany
Local Institution - 0019
Herne, , Germany
Local Institution - 0017
Jena, , Germany
Local Institution - 0034
Munich, , Germany
Local Institution - 0018
Münster, , Germany
Local Institution - 0037
Nuremberg, , Germany
Local Institution - 0042
Nürtingen, , Germany
Local Institution - 0036
Rostock, , Germany
Local Institution - 0033
Tübingen, , Germany
Local Institution - 0035
Wesel, , Germany
Local Institution - 0071
Arezzo, , Italy
Local Institution - 0052
Milan, , Italy
Local Institution - 0053
Napoli, , Italy
Local Institution - 0072
Parma, , Italy
Local Institution - 0051
Terni, , Italy
Local Institution - 0055
Krakow, Lesser Poland Voivodeship, Poland
Local Institution - 0066
Koszalin, , Poland
Local Institution - 0054
Warsaw, , Poland
Local Institution - 0022
Madrid, Sede Madrid, Spain
Local Institution - 0026
Badajoz, , Spain
Local Institution - 0025
Barcelona, , Spain
Local Institution - 0020
Madrid, , Spain
Local Institution - 0021
Madrid, , Spain
Local Institution - 0024
Málaga, , Spain
Local Institution - 0023
Santiago Compostela, , Spain
Countries
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References
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Sharma P, Pachynski RK, Narayan V, Flechon A, Gravis G, Galsky MD, Mahammedi H, Patnaik A, Subudhi SK, Ciprotti M, Simsek B, Saci A, Hu Y, Han GC, Fizazi K. Nivolumab Plus Ipilimumab for Metastatic Castration-Resistant Prostate Cancer: Preliminary Analysis of Patients in the CheckMate 650 Trial. Cancer Cell. 2020 Oct 12;38(4):489-499.e3. doi: 10.1016/j.ccell.2020.08.007. Epub 2020 Sep 10.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2016-001928-54
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-650
Identifier Type: -
Identifier Source: org_study_id