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

NCT03338790 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CA209-9KD
• Study Type: interventional
• Target: 292
• Locations: 11 countries
• Sites: 66

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• 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

  Up to approximately 36 months

• 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

  Up to approximately 36 months

Secondary Outcomes (10)

• Radiographic Progression-Free Survival (rPFS)

  Up to approximately 84 months

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

  Up to approximately 84 months

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

  Up to approximately 84 months

• Prostate-Specific Antigen Time to Progression (TTP-PSA)

  Up to approximately 84 months

• Overall Survival (OS)

  Up to approximately 84 months

Study Arms (3)

nivolumab + rucaparib

EXPERIMENTAL

Specified dose on specified days

Biological: nivolumab; Drug: rucaparib

nivolumab + docetaxel + prednisone

EXPERIMENTAL

Specified dose on specified days

Biological: nivolumab; Drug: docetaxel; Drug: prednisone

nivolumab + enzalutamide

EXPERIMENTAL

Specified dose on specified days

Biological: nivolumab; Drug: enzalutamide

Interventions

nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: BMS-936558, Opdivo

nivolumab + docetaxel + prednisone; nivolumab + enzalutamide; nivolumab + rucaparib

docetaxel DRUG

Specified dose on specified days

nivolumab + docetaxel + prednisone

enzalutamide DRUG

Specified dose on specified days

nivolumab + enzalutamide

rucaparib DRUG

Specified dose on specified days

nivolumab + rucaparib

prednisone DRUG

Specified dose on specified days

nivolumab + docetaxel + prednisone

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: collaborator
• Bristol-Myers Squibb: lead
• Clovis Oncology, Inc.: collaborator

Study Sites (66)

Local Institution - 0036

Daphne, Alabama, 36526, United States

Location

Local Institution - 0010

Rancho Mirage, California, 92270, United States

Location

Local Institution - 0049

New Haven, Connecticut, 06520, United States

Location

Local Institution - 0037

Miami, Florida, 33176, United States

Location

Local Institution - 0009

Marietta, Georgia, 30060, United States

Location

Local Institution - 0065

Louisville, Kentucky, 40207, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Local Institution - 0040

Rockville, Maryland, 20850, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Local Institution - 0012

Detroit, Michigan, 48201, United States

Location

Local Institution - 0069

Jackson, Mississippi, 39202, United States

Location

Local Institution - 0011

St Louis, Missouri, 63110, United States

Location

Local Institution - 0035

Omaha, Nebraska, 68130, United States

Location

Local Institution - 0038

Albany, New York, 12208, United States

Location

Local Institution - 0068

New York, New York, 10032, United States

Location

Local Institution - 0041

Durham, North Carolina, 27710, United States

Location

Local Institution - 0024

Portland, Oregon, 97225, United States

Location

Local Institution - 0053

Allentown, Pennsylvania, 18103, United States

Location

Local Institution - 0039

Fairfax, Virginia, 22031, United States

Location

Local Institution - 0052

CABA, Buenos Aires, 1426, Argentina

Location

Local Institution - 0042

Capital Federal, Buenos Aires, 1426, Argentina

Location

Local Institution - 0062

Villa Siburu, Córdoba Province, 5003, Argentina

Location

Local Institution - 0044

Buenos Aires, Distrito Federal, C1280, Argentina

Location

Local Institution - 0043

CABA, 1199, Argentina

Location

Local Institution - 0015

Camperdown, New South Wales, 2050, Australia

Location

Local Institution - 0017

Westmead, New South Wales, 2145, Australia

Location

Local Institution - 0014

South Brisbane, Queensland, 4101, Australia

Location

Local Institution - 0016

Elizabeth Vale, South Australia, 5112, Australia

Location

Local Institution - 0050

Clayton, Victoria, 0, Australia

Location

Local Institution - 0013

Heidelberg, Victoria, 3084, Australia

Location

Local Institution - 0020

Belo Horizonte, Minas Gerais, 30110-022, Brazil

Location

Local Institution - 0074

Belo Horizonte, Minas Gerais, 30130-090, Brazil

Location

Local Institution - 0075

Curitiba, Paraná, 81480-580, Brazil

Location

Local Institution - 0019

Rio de Janeiro, Rio de Janeiro, 22793-080, Brazil

Location

Local Institution - 0018

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Local Institution - 0021

Porto Alegre, Rio Grande do Sul, 90035001, Brazil

Location

Local Institution - 0022

Campinas, São Paulo, 13075-460, Brazil

Location

Local Institution - 0073

São Paulo, São Paulo, 01308-050, Brazil

Location

Local Institution - 0071

São Paulo, São Paulo, 05652-900, Brazil

Location

Local Institution - 0067

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Local Institution - 0059

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Local Institution - 0055

Hamilton, Ontario, L8V 5C2, Canada

Location

Local Institution - 0066

Montreal, Quebec, H2X 0C1, Canada

Location

Local Institution - 0056

Québec, Quebec, G1J 1Z4, Canada

Location

Local Institution - 0051

Viña del Mar, Región de Valparaíso, 2540364, Chile

Location

Local Institution - 0034

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0027

Montería, Departamento de Córdoba, 0, Colombia

Location

Local Institution - 0026

Medellín, 0, Colombia

Location

Local Institution - 0033

Besançon, 25030, France

Location

Local Institution - 0032

Clermont-Ferrand, 63000, France

Location

Local Institution - 0031

Lyon, 69008, France

Location

Local Institution - 0030

Marseille, 13273, France

Location

Local Institution - 0029

Villejuif, 94800, France

Location

Local Institution - 0001

Essen, 45122, Germany

Location

Local Institution - 0006

Göttingen, 37075, Germany

Location

Local Institution - 0004

Heidelberg, D-69120, Germany

Location

Local Institution - 0002

Jena, 07747, Germany

Location

Local Institution - 0007

Koblenz, 56068, Germany

Location

Local Institution - 0064

München, 81675, Germany

Location

Local Institution - 0054

León, Guanajuato, 37000, Mexico

Location

Local Institution - 0061

Guadalajara, Jalisco, 44130, Mexico

Location

Local Institution - 0048

Guadalajara, Jalisco, 44280, Mexico

Location

Local Institution - 0025

Culiacán, Sinaloa, 80230, Mexico

Location

Local Institution - 0045

Madrid, 28041, Spain

Location

Local Institution - 0046

Pamplona, 31008, Spain

Location

Local Institution - 0047

Seville, 41013, Spain

Location

Related Publications (2)

• 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.

  PMID: 35977756 DERIVED

• 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.

  PMID: 34802864 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Nivolumab; Docetaxel; enzalutamide; rucaparib; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email:

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 9, 2017
• Study Start: December 19, 2017
• Primary Completion: January 13, 2021
• Study Completion: January 10, 2025
• Last Updated: January 27, 2026
• Results First Posted: February 9, 2022

Record last verified: 2026-01

Locations

FR (5); US (19); BR (9); DE (6); ME (4); AR (5); ES (3); AU (6); CO (2); CA (5); CL (2)