An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (CheckMate 9KD)

January 8, 2026 updated by: Bristol-Myers Squibb

A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer

The purpose of this study is to assess safety and efficacy of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate cancer that has spread.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

292

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • CABA, Argentina, 1199
        • Local Institution - 0043
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, 1426
        • Local Institution - 0052
      • Capital Federal, Buenos Aires, Argentina, 1426
        • Local Institution - 0042
    • Córdoba Province
      • Villa Siburu, Córdoba Province, Argentina, 5003
        • Local Institution - 0062
    • Distrito Federal
      • Buenos Aires, Distrito Federal, Argentina, C1280
        • Local Institution - 0044
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Local Institution - 0015
      • Westmead, New South Wales, Australia, 2145
        • Local Institution - 0017
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Local Institution - 0014
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Local Institution - 0016
    • Victoria
      • Clayton, Victoria, Australia
        • Local Institution - 0050
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 0013
  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30110-022
        • Local Institution - 0020
      • Belo Horizonte, Minas Gerais, Brazil, 30130-090
        • Local Institution - 0074
    • Paraná
      • Curitiba, Paraná, Brazil, 81480-580
        • Local Institution - 0075
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • Local Institution - 0018
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035001
        • Local Institution - 0021
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 22793-080
        • Local Institution - 0019
    • São Paulo
      • Campinas, São Paulo, Brazil, 13075-460
        • Local Institution - 0022
      • São Paulo, São Paulo, Brazil, 01308-050
        • Local Institution - 0073
      • São Paulo, São Paulo, Brazil, 05652-900
        • Local Institution - 0071
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Local Institution - 0067
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Local Institution - 0059
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Local Institution - 0055
    • Quebec
      • Montreal, Quebec, Canada, H2X 0C1
        • Local Institution - 0066
      • Québec, Quebec, Canada, G1J 1Z4
        • Local Institution - 0056
  • Chile
    • Región de Valparaíso
      • Viña del Mar, Región de Valparaíso, Chile, 2540364
        • Local Institution - 0051
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Local Institution - 0034
  • Colombia
      • Medellín, Colombia
        • Local Institution - 0026
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia
        • Local Institution - 0027
  • France
      • Besançon, France, 25030
        • Local Institution - 0033
      • Clermont-Ferrand, France, 63000
        • Local Institution - 0032
      • Lyon, France, 69008
        • Local Institution - 0031
      • Marseille, France, 13273
        • Local Institution - 0030
      • Villejuif, France, 94800
        • Local Institution - 0029
  • Germany
      • Essen, Germany, 45122
        • Local Institution - 0001
      • Göttingen, Germany, 37075
        • Local Institution - 0006
      • Heidelberg, Germany, D-69120
        • Local Institution - 0004
      • Jena, Germany, 07747
        • Local Institution - 0002
      • Koblenz, Germany, 56068
        • Local Institution - 0007
      • München, Germany, 81675
        • Local Institution - 0064
  • Mexico
    • Guanajuato
      • León, Guanajuato, Mexico, 37000
        • Local Institution - 0054
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44130
        • Local Institution - 0061
      • Guadalajara, Jalisco, Mexico, 44280
        • Local Institution - 0048
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80230
        • Local Institution - 0025
  • Spain
      • Madrid, Spain, 28041
        • Local Institution - 0045
      • Pamplona, Spain, 31008
        • Local Institution - 0046
      • Seville, Spain, 41013
        • Local Institution - 0047
  • United States
    • Alabama
      • Daphne, Alabama, United States, 36526
        • Local Institution - 0036
    • California
      • Rancho Mirage, California, United States, 92270
        • Local Institution - 0010
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Local Institution - 0049
    • Florida
      • Miami, Florida, United States, 33176
        • Local Institution - 0037
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Local Institution - 0009
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Local Institution - 0065
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Local Institution - 0040
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Local Institution - 0012
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Local Institution - 0069
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Local Institution - 0011
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Local Institution - 0035
    • New York
      • Albany, New York, United States, 12208
        • Local Institution - 0038
      • New York, New York, United States, 10032
        • Local Institution - 0068
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Local Institution - 0041
    • Oregon
      • Portland, Oregon, United States, 97225
        • Local Institution - 0024
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Local Institution - 0053
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Local Institution - 0039

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologic confirmation of adenocarcinoma of the prostate
  • 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:

  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast
  • 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

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nivolumab + rucaparib
Specified dose on specified days
Biological: nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558, Opdivo
Drug: rucaparib
Specified dose on specified days
Experimental: nivolumab + docetaxel + prednisone
Specified dose on specified days
Biological: nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558, Opdivo
Drug: docetaxel
Specified dose on specified days
Drug: prednisone
Specified dose on specified days
Experimental: nivolumab + enzalutamide
Specified dose on specified days
Biological: nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558, Opdivo
Drug: enzalutamide
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3)
Time Frame: Up to approximately 36 months
Objective response rate per prostate cancer clinical trials working group 3 (ORR-PCWG3) for target lesions and assessed by MRI is the percentage of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among treated participants who have measurable disease
Up to approximately 36 months
Prostate-Specific Antigen Response Rate (RR-PSA)
Time Frame: Up to approximately 36 months
Prostate-specific antigen response rate (RR-PSA) is the percentage of treated participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result
Up to approximately 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Progression-Free Survival (rPFS)
Time Frame: Up to approximately 84 months
Radiographic progress-free survival (rPFS) is the time between treatment initiation and the first date of documented progression or death due to any cause, whichever occurs first assessed by the investigator per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Up to approximately 84 months
Time to Response Per Prostate Cancer Clinical Trials Working Group 3 (TTR-PCWG3)
Time Frame: Up to approximately 84 months
Time to response per prostate cancer clinical trials working group 3 (TTR-PCWG3) is the time from treatment initiation to the date of the first documented complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Up to approximately 84 months
Duration of Response Per Prostate Cancer Clinical Trials Working Group 3 (DOR-PCWG3)
Time Frame: Up to approximately 84 months
Duration of response per prostate cancer clinical trials working group 3 (DOR-PCWG3) is the time between the date of first response (complete response/partial response per PCWG3) to the date of first documented radiographic progression per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) or death due to any cause
Up to approximately 84 months
Prostate-Specific Antigen Time to Progression (TTP-PSA)
Time Frame: Up to approximately 84 months
Prostate-specific antigen time to progression (TTP-PSA) is the time between treatment initiation to the date of PSA progression per prostate cancer clinical trials working group 3 (PCWG3)
Up to approximately 84 months
Overall Survival (OS)
Time Frame: Up to approximately 84 months
Overall Survival (OS) is the time between treatment initiation and the date of death from any cause. For participants who are alive, their survival time will be censored at the last date that they were known to be alive. OS will be censored for participants at the date of treatment initiation if they had no follow-up
Up to approximately 84 months
Number of Participants With Adverse Events (AEs)
Time Frame: From first dose to up to 30 days post last dose (Up to 82 months)
Number of Participants with any grade adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and immune-mediated AEs using the Common Toxicity Criteria Grade for Adverse Events (CTCAE V4)
From first dose to up to 30 days post last dose (Up to 82 months)
Number of Participants Who Died
Time Frame: Up to 84 months
Number of participants who died due to any cause.
Up to 84 months
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Time Frame: From first dose to up to 30 days post last dose (up to 82 months)

Number of participants with laboratory abnormalities in specific liver tests based on SI conventional units to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:

  • ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN
  • Total bilirubin > 2 x ULN
  • ALP > 1.5 x ULN
  • Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN
  • Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN
  • Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
  • Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
From first dose to up to 30 days post last dose (up to 82 months)
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Time Frame: From first dose to up to 30 days post last dose (Up to 82 months)

Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:

  • TSH value > ULN and
  • with baseline TSH value <= ULN
  • with at least one FT3/FT4 test value < LLN within 2-week window after the abnormal TSH test
  • with all FT3/FT4 test values >= LLN within 2-week window after the abnormal TSH test
  • with FT3/FT4 missing within 2-week window after the abnormal TSH test.
  • TSH < LLN and
  • with baseline TSH value >= LLN
  • with at least one FT3/FT4 test value > ULN within 2-week window after the abnormal TSH test
  • with all FT3/FT4 test values <= ULN within 2-week window after the abnormal TSH test
  • with FT3/FT4 missing within 2-week window after the abnormal TSH test
From first dose to up to 30 days post last dose (Up to 82 months)
Number of Participants With Laboratory Values Change From Baseline
Time Frame: From first dose to up to 30 days post last dose (Up to 82 months)
Number of participants changed from baseline in laboratory values of worst toxicity grade (grade 0= wnl, grade 1= mild, grade 2= moderate, grade 3= severe) based on US conventional units by cohort
From first dose to up to 30 days post last dose (Up to 82 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Astellas Pharma Inc
Clovis Oncology, Inc.

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2017

Primary Completion (Actual)

January 13, 2021

Study Completion (Actual)

January 10, 2025

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

November 8, 2017

First Posted (Actual)

November 9, 2017

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-9KD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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