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Prostate CancerPhase 2CheckMate 9KDNCT03338790

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

A Phase 2 study testing nivolumab, docetaxel and enzalutamide in people with Prostate Cancer, run by Bristol-Myers Squibb at 66 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
nivolumab, docetaxel and enzalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
292 participants
Where
66 sitesin 11 countries
Study dates
19 Dec 2017to 10 Jan 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

66 sites in 11 countries.

66 sites in 11 countries

United States19 sites

  • Local Institution - 0038

    Albany, New York, 12208

  • Local Institution - 0053

    Allentown, Pennsylvania, 18103

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Local Institution - 0036

    Daphne, Alabama, 36526

  • Local Institution - 0012

    Detroit, Michigan, 48201

  • Local Institution - 0041

    Durham, North Carolina, 27710

  • Local Institution - 0039

    Fairfax, Virginia, 22031

  • Local Institution - 0069

    Jackson, Mississippi, 39202

  • Local Institution - 0065

    Louisville, Kentucky, 40207

  • Local Institution - 0009

    Marietta, Georgia, 30060

  • Local Institution - 0037

    Miami, Florida, 33176

  • Local Institution - 0049

    New Haven, Connecticut, 06520

  • Tulane University

    New Orleans, Louisiana, 70112

  • Local Institution - 0068

    New York, New York, 10032

  • Local Institution - 0035

    Omaha, Nebraska, 68130

  • Local Institution - 0024

    Portland, Oregon, 97225

  • Local Institution - 0010

    Rancho Mirage, California, 92270

  • Local Institution - 0040

    Rockville, Maryland, 20850

  • Local Institution - 0011

    St Louis, Missouri, 63110

Other trials in United States

Brazil9 sites

  • Local Institution - 0020

    Belo Horizonte, Minas Gerais, 30110-022

  • Local Institution - 0074

    Belo Horizonte, Minas Gerais, 30130-090

  • Local Institution - 0022

    Campinas, São Paulo, 13075-460

  • Local Institution - 0075

    Curitiba, Paraná, 81480-580

  • Local Institution - 0018

    Ijuí, Rio Grande do Sul, 98700-000

  • Local Institution - 0021

    Porto Alegre, Rio Grande do Sul, 90035001

  • Local Institution - 0019

    Rio de Janeiro, Rio de Janeiro, 22793-080

  • Local Institution - 0073

    São Paulo, São Paulo, 01308-050

  • Local Institution - 0071

    São Paulo, São Paulo, 05652-900

Other trials in Brazil

Australia6 sites

  • Local Institution - 0015

    Camperdown, New South Wales, 2050

  • Local Institution - 0050

    Clayton, Victoria, 0

  • Local Institution - 0016

    Elizabeth Vale, South Australia, 5112

  • Local Institution - 0013

    Heidelberg, Victoria, 3084

  • Local Institution - 0014

    South Brisbane, Queensland, 4101

  • Local Institution - 0017

    Westmead, New South Wales, 2145

Other trials in Australia

Germany6 sites

  • Local Institution - 0001

    Essen, 45122

  • Local Institution - 0006

    Göttingen, 37075

  • Local Institution - 0004

    Heidelberg, D-69120

  • Local Institution - 0002

    Jena, 07747

  • Local Institution - 0007

    Koblenz, 56068

  • Local Institution - 0064

    München, 81675

Other trials in Germany

Argentina5 sites

  • Local Institution - 0044

    Buenos Aires, Distrito Federal, C1280

  • Local Institution - 0052

    CABA, Buenos Aires, 1426

  • Local Institution - 0043

    CABA, 1199

  • Local Institution - 0042

    Capital Federal, Buenos Aires, 1426

  • Local Institution - 0062

    Villa Siburu, Córdoba Province, 5003

Other trials in Argentina

Canada5 sites

  • Local Institution - 0055

    Hamilton, Ontario, L8V 5C2

  • Local Institution - 0067

    Kelowna, British Columbia, V1Y 5L3

  • Local Institution - 0059

    Moncton, New Brunswick, E1C 6Z8

  • Local Institution - 0066

    Montreal, Quebec, H2X 0C1

  • Local Institution - 0056

    Québec, Quebec, G1J 1Z4

Other trials in Canada

France5 sites

  • Local Institution - 0033

    Besançon, 25030

  • Local Institution - 0032

    Clermont-Ferrand, 63000

  • Local Institution - 0031

    Lyon, 69008

  • Local Institution - 0030

    Marseille, 13273

  • Local Institution - 0029

    Villejuif, 94800

Other trials in France

Mexico4 sites

  • Local Institution - 0025

    Culiacán, Sinaloa, 80230

  • Local Institution - 0061

    Guadalajara, Jalisco, 44130

  • Local Institution - 0048

    Guadalajara, Jalisco, 44280

  • Local Institution - 0054

    León, Guanajuato, 37000

Other trials in Mexico

Spain3 sites

  • Local Institution - 0045

    Madrid, 28041

  • Local Institution - 0046

    Pamplona, 31008

  • Local Institution - 0047

    Seville, 41013

Other trials in Spain

Chile2 sites

  • Local Institution - 0034

    Santiago, Santiago Metropolitan, 8420383

  • Local Institution - 0051

    Viña del Mar, Valparaiso, 2540364

Other trials in Chile

Colombia2 sites

  • Local Institution - 0026

    Medellín, 0

  • Local Institution - 0027

    Montería, Departamento de Córdoba, 0

Other trials in Colombia

About this study

Official title: 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.

Conditions
Prostate Cancer
Being tested
nivolumab, docetaxel, enzalutamide, rucaparib, prednisone
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nivolumabBiological

    Also called BMS-936558, Opdivo

    Specified dose on specified days

  • docetaxelDrug

    Specified dose on specified days

  • enzalutamideDrug

    Specified dose on specified days

  • rucaparibDrug

    Specified dose on specified days

  • prednisoneDrug

    Specified dose on specified days

Study groups in NCT03338790
Study groupRoleWhat they receive
nivolumab + rucaparibExperimentalSpecified dose on specified days
Receives: Biological: nivolumab; Drug: rucaparib
nivolumab + docetaxel + prednisoneExperimentalSpecified dose on specified days
Receives: Biological: nivolumab; Drug: docetaxel; Drug: prednisone
nivolumab + enzalutamideExperimentalSpecified dose on specified days
Receives: Biological: nivolumab; Drug: enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3)

    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

    Measured: Up to approximately 36 months

  2. Prostate-Specific Antigen Response Rate (RR-PSA)

    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

    Measured: Up to approximately 36 months

Secondary outcomes (10)

  1. Radiographic Progression-Free Survival (rPFS)

    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)

    Measured: Up to approximately 84 months

  2. Time to Response Per Prostate Cancer Clinical Trials Working Group 3 (TTR-PCWG3)

    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)

    Measured: Up to approximately 84 months

  3. Duration of Response Per Prostate Cancer Clinical Trials Working Group 3 (DOR-PCWG3)

    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

    Measured: Up to approximately 84 months

  4. Prostate-Specific Antigen Time to Progression (TTP-PSA)

    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)

    Measured: Up to approximately 84 months

  5. Overall Survival (OS)

    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

    Measured: Up to approximately 84 months

  6. Number of Participants With Adverse Events (AEs)

    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)

    Measured: From first dose to up to 30 days post last dose (Up to 82 months)

  7. Number of Participants Who Died

    Number of participants who died due to any cause.

    Measured: Up to 84 months

  8. Number of Participants With Laboratory Abnormalities in Specific Liver Tests

    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

    Measured: From first dose to up to 30 days post last dose (up to 82 months)

  9. Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

    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

    Measured: From first dose to up to 30 days post last dose (Up to 82 months)

  10. Number of Participants With Laboratory Values Change From Baseline

    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

    Measured: From first dose to up to 30 days post last dose (Up to 82 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2017
  2. Study start19 Dec 2017
  3. Primary completion13 Jan 2021
  4. Study completion10 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
292 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03338790
Sponsor's protocol ID
CA209-9KD
Acronym
CheckMate 9KD
Status last verified
Jan 2026
First submitted
8 Nov 2017
Last updated
27 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 35977756

  • 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.

    PubMed 34802864

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing nivolumab, docetaxel and enzalutamide in people with Prostate Cancer, run by Bristol-Myers Squibb at 66 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Brazil, Australia, Germany, Argentina and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3) (time frame: Up to approximately 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03338790, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.

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