An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer
NCT ID: NCT03338790
Last Updated: 2025-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
292 participants
INTERVENTIONAL
2017-12-19
2025-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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nivolumab + rucaparib
Specified dose on specified days
nivolumab
Specified dose on specified days
rucaparib
Specified dose on specified days
nivolumab + docetaxel + prednisone
Specified dose on specified days
nivolumab
Specified dose on specified days
docetaxel
Specified dose on specified days
prednisone
Specified dose on specified days
nivolumab + enzalutamide
Specified dose on specified days
nivolumab
Specified dose on specified days
enzalutamide
Specified dose on specified days
Interventions
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nivolumab
Specified dose on specified days
docetaxel
Specified dose on specified days
enzalutamide
Specified dose on specified days
rucaparib
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
* Evidence of stage IV disease on previous bone, CT, and/or MRI scan
* Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
* Mandatory plasma and fresh or archival tumor tissue must be submitted
Exclusion Criteria
* Participants with active brain metastases
* Participants must have recovered from the effects of major surgery requiring general anesthesia or significant traumatic injury at least 14 days before treatment arm assignment
18 Years
MALE
No
Sponsors
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Clovis Oncology, Inc.
INDUSTRY
Astellas Pharma Inc
INDUSTRY
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 - 0036
Daphne, Alabama, United States
Local Institution - 0010
Rancho Mirage, California, United States
Local Institution - 0049
New Haven, Connecticut, United States
Local Institution - 0037
Miami, Florida, United States
Local Institution - 0009
Marietta, Georgia, United States
Local Institution - 0065
Louisville, Kentucky, United States
Tulane University
New Orleans, Louisiana, United States
Local Institution - 0040
Rockville, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Local Institution - 0012
Detroit, Michigan, United States
Local Institution - 0069
Jackson, Mississippi, United States
Local Institution - 0011
St Louis, Missouri, United States
Local Institution - 0035
Omaha, Nebraska, United States
Local Institution - 0038
Albany, New York, United States
Local Institution - 0068
New York, New York, United States
Local Institution - 0041
Durham, North Carolina, United States
Local Institution - 0024
Portland, Oregon, United States
Local Institution - 0053
Allentown, Pennsylvania, United States
Local Institution - 0039
Fairfax, Virginia, United States
Local Institution - 0052
CABA, Buenos Aires, Argentina
Local Institution - 0042
Capital Federal, Buenos Aires, Argentina
Local Institution - 0062
Villa Siburu, Córdoba Province, Argentina
Local Institution - 0044
Buenos Aires, Distrito Federal, Argentina
Local Institution - 0043
CABA, , Argentina
Local Institution - 0015
Camperdown, New South Wales, Australia
Local Institution - 0017
Westmead, New South Wales, Australia
Local Institution - 0014
South Brisbane, Queensland, Australia
Local Institution - 0016
Elizabeth Vale, South Australia, Australia
Local Institution - 0050
Clayton, Victoria, Australia
Local Institution - 0013
Heidelberg, Victoria, Australia
Local Institution - 0020
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0074
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0075
Curitiba, Paraná, Brazil
Local Institution - 0018
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0021
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0022
Campinas, São Paulo, Brazil
Local Institution - 0071
São Paulo, São Paulo, Brazil
Local Institution - 0019
Rio de Janeiro, , Brazil
Local Institution - 0073
São Paulo, , Brazil
Local Institution - 0067
Kelowna, British Columbia, Canada
Local Institution - 0059
Moncton, New Brunswick, Canada
Local Institution - 0055
Hamilton, Ontario, Canada
Local Institution - 0066
Montreal, Quebec, Canada
Local Institution - 0056
Québec, Quebec, Canada
Local Institution - 0051
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0034
Santiago, Santiago Metropolitan, Chile
Local Institution - 0027
Montería, Departamento de Córdoba, Colombia
Local Institution - 0026
Medellín, , Colombia
Local Institution - 0033
Besançon, , France
Local Institution - 0032
Clermont-Ferrand, , France
Local Institution - 0031
Lyon, , France
Local Institution - 0030
Marseille, , France
Local Institution - 0029
Villejuif, , France
Local Institution - 0001
Essen, , Germany
Local Institution - 0006
Göttingen, , Germany
Local Institution - 0004
Heidelberg, , Germany
Local Institution - 0002
Jena, , Germany
Local Institution - 0007
Koblenz, , Germany
Local Institution - 0064
München, , Germany
Local Institution - 0054
León, Guanajuato, Mexico
Local Institution - 0061
Guadalajara, Jalisco, Mexico
Local Institution - 0048
Guadalajara, Jalisco, Mexico
Local Institution - 0025
Culiacán, Sinaloa, Mexico
Local Institution - 0045
Madrid, , Spain
Local Institution - 0046
Pamplona, , Spain
Local Institution - 0047
Seville, , Spain
Countries
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References
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Fizazi K, Retz M, Petrylak DP, Goh JC, Perez-Gracia J, Lacombe L, Zschabitz S, Burotto M, Mahammedi H, Gravis G, Bastos DA, McCune SL, Vazquez Limon JC, Kwan EM, Castellano D, Flechon A, Saad F, Grimm MO, Shaffer DR, Armstrong AJ, Bhagavatheeswaran P, Amin NP, Unsal-Kacmaz K, Wang X, Li J, Loehr A, Pachynski RK. Nivolumab plus rucaparib for metastatic castration-resistant prostate cancer: results from the phase 2 CheckMate 9KD trial. J Immunother Cancer. 2022 Aug;10(8):e004761. doi: 10.1136/jitc-2022-004761.
Fizazi K, Gonzalez Mella P, Castellano D, Minatta JN, Rezazadeh Kalebasty A, Shaffer D, Vazquez Limon JC, Sanchez Lopez HM, Armstrong AJ, Horvath L, Bastos DA, Amin NP, Li J, Unsal-Kacmaz K, Retz M, Saad F, Petrylak DP, Pachynski RK. Nivolumab plus docetaxel in patients with chemotherapy-naive metastatic castration-resistant prostate cancer: results from the phase II CheckMate 9KD trial. Eur J Cancer. 2022 Jan;160:61-71. doi: 10.1016/j.ejca.2021.09.043. Epub 2021 Nov 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA209-9KD
Identifier Type: -
Identifier Source: org_study_id
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