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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03338790
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : January 15, 2019
Sponsor:
Collaborators:
Clovis Oncology, Inc.
Astellas Pharma Inc
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: Nivolumab Drug: Docetaxel Drug: Enzalutamide Drug: Rucaparib Drug: Prednisone Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : February 18, 2020
Estimated Study Completion Date : November 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Arm A
Nivolumab in combination with Rucaparib
Biological: Nivolumab
Specified dose on specified day
Other Name: BMS-936558

Drug: Rucaparib
Specified dose on specified day

Experimental: Arm B
Nivolumab in combination with Docetaxel
Biological: Nivolumab
Specified dose on specified day
Other Name: BMS-936558

Drug: Docetaxel
Specified dose on specified day

Drug: Prednisone
Specified dose on specified day

Experimental: Arm C
Nivolumab in combination with Enzalutamide
Biological: Nivolumab
Specified dose on specified day
Other Name: BMS-936558

Drug: Enzalutamide
Specified dose on specified day




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Approximately 12 months ]
    Assessed per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)

  2. Prostate-specific antigen response rate (RR-PSA) [ Time Frame: Approximately 12 months ]
    Assessed per the proportion of treated participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result


Secondary Outcome Measures :
  1. Radiographic progression-free survival (rPFS) [ Time Frame: Approximately 12 months ]
    Assessed per PCWG3

  2. Time to response (TTR) [ Time Frame: Approximately 12 months ]
    Assessed per PCWG3

  3. Duration of response (DOR) [ Time Frame: Approximately 12 months ]
    Assessed per PCWG3

  4. Time to prostate-specific antigen progression (TTP-PSA) [ Time Frame: Approximately 12 months ]
    Assessed per PCWG3

  5. Overall Survival (OS) [ Time Frame: Up to 5 years ]
    Time between treatment initiation and the date of death from any cause

  6. Incidence of adverse events (AEs) [ Time Frame: Approximately 12 months ]
  7. Incidence of serious adverse events (SAEs) [ Time Frame: Approximately 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338790


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

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Locations
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United States, Alabama
Southern Cancer Center Pc Recruiting
Daphne, Alabama, United States, 36526
Contact: Michael Meshad, Site 0036    251-607-5036      
United States, California
Desert Hematology Oncology Medical Group Recruiting
Rancho Mirage, California, United States, 92270
Contact: David Young, Site 0010    7605683613110      
Local Institution Withdrawn
San Francisco, California, United States, 94158
United States, Connecticut
Yale University School Of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Daniel Petrylak, Site 0049    203-785-6821      
United States, Florida
Baptist Health Medical Group Oncology Recruiting
Miami, Florida, United States, 33176
Contact: Antonio Muina, Site 0037    786-596-7706      
United States, Georgia
Northwest Georgia Oncology Centers, P.C. Recruiting
Marietta, Georgia, United States, 30060
Contact: Steven McCune, Site 0009    770-333-2161      
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40202
Contact: Arash Rezazadeh Kalebasty, Site 0065         
United States, Louisiana
Tulane University Recruiting
New Orleans, Louisiana, United States, 70112
Contact: A. Oliver Sartor, Site 0072         
United States, Maryland
Maryland Oncology Hematology, P.A. Recruiting
Rockville, Maryland, United States, 20850
Contact: Manish Agrawal, Site 0040    41096422121132      
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Gretchen Gignac, Site 0070         
United States, Michigan
Karmanos Cancer Center Recruiting
Detroit, Michigan, United States, 48201
Contact: Elisabeth Heath, Site 0012    313-576-9372      
United States, Minnesota
Local Institution Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Site 0076         
United States, Mississippi
Jackson Oncology Associates, Pllc Recruiting
Jackson, Mississippi, United States, 39202
Contact: Justin Baker, Site 0069         
United States, Missouri
Washington University School Of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Russell Pachynski, Site 0011    314-747-1343      
United States, Nebraska
Oncology Hematology West P.C. dba Nebraska Cancer Specialists Recruiting
Omaha, Nebraska, United States, 68130
Contact: Ralph Hauke, Site 0035    402-691-6971      
United States, New York
New York Oncology Hematology, P.C. Recruiting
Amsterdam, New York, United States, 12010
Contact: David Shaffer, Site 0038    518-262-2767      
Columbia University Medical Center (Cumc) Recruiting
New York, New York, United States, 10032
Contact: Mark Stein, Site 0068         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Andrew Armstrong, Site 0041    919-681-1030      
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Brendan Curti, Site 0024    503-215-2604      
United States, Pennsylvania
Lehigh Valley Health Network Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Maged Khalil, Site 0053         
United States, Virginia
Virginia Cancer Care Specialist, PC Recruiting
Fairfax, Virginia, United States, 22031
Contact: Daniel Chong, Site 0039    540-662-1108      
Argentina
Hospital Militar Central Recruiting
Caba, Buenos Aires, Argentina, 1426
Contact: Emilio Batagelj, Site 0052         
Instituto Medico Especializado Alexander Fleming Recruiting
Capital Federal, Buenos Aires, Argentina, 1426
Contact: Juan Sade, Site 0042         
Hospital Britanico De Buenos Aires Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1280
Contact: Ernesto Korbenfeld, Site 0044         
Hospital Italiano De Buenos Aires Recruiting
Caba, Argentina, 1199
Contact: Jose Minatta, Site 0043         
Instituto Oncologico De Cordoba Recruiting
Cordoba, Argentina, 5000
Contact: Martin Richardet, Site 0062         
Australia, New South Wales
Chris O'Brien Lifehouse Recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Lisa Horvath, Site 0015    +61285140574      
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Howard Gurney, Site 0017    +61288909526 000000000      
Australia, Queensland
Integrated Clinical Oncology Network Pty Ltd (ICON) Recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Jeffrey Goh, Site 0014    +61737374500      
Australia, Victoria
Monash Medical Centre Clayton Recruiting
Clayton, Victoria, Australia, 3168
Contact: Edmond Kwan, Site 0050    +61385722017      
Austin Hospital Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Andrew Weickhardt, Site 0013    +61394969712 00000 0000      
Australia
Lyell McEwin Hospital Recruiting
Elizabeth Vale, Australia, 5112
Contact: Christopher Hocking, Site 0016    +61882820833      
Brazil
PERSONAL Oncologia de Precisao e Personalizada Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30130-090
Contact: Andre Murad, Site 0074    +553136576864      
Cetus Hospital Dia Oncologia Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30150-270
Contact: Charles Padua, Site 0020    +553135191685      
CIONC Recruiting
Curitiba, Parana, Brazil, 81480-580
Contact: Karina Vianna, Site 0075    +554130242421 (00)0000-0000      
Associacao Hospital de Caridade Ijui Recruiting
Ijui, RIO Grande DO SUL, Brazil, 98700-000
Contact: Fabio Franke, Site 0018    +555533319393      
Hospital Moinhos de Vento Recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90035-001
Contact: Sergio Roithmann, Site 0021    +555133143693      
Radium Instituto de Oncologia Recruiting
Campinas, SAO Paulo, Brazil, 13075-460
Contact: Andre Sasse, Site 0022    +551937534100      
Instituto COI de Educacao e Pesquisa Recruiting
Rio de Janeiro, Brazil, 22793-080
Contact: Diogo Rosa, Site 0019    +552135092116 (00)00000000      
Local Institution Withdrawn
Santa Catarina, Brazil, 89812-021
Hospital Sirio Libanes Recruiting
Sao Paulo, Brazil, 01308-050
Contact: Carlos Dzik, Site 0073    +551133945298      
Local Institution Recruiting
Sao Paulo, Brazil, 05651-901
Contact: Site 0071         
Canada, Alberta
Local Institution Withdrawn
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Local Institution Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Site 0063         
Canada, New Brunswick
The Moncton Hospital Recruiting
Moncton, New Brunswick, Canada, E1C 6Z8
Contact: Mahmoud Abdelsalam, Site 0059    5068575669      
Local Institution Withdrawn
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Ontario
Juravinski Cancer Center Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Sebastien Hotte, Site 0055    9053879495      
Local Institution Withdrawn
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Centre Hospitalier De L'Universite De Montreal Recruiting
Montreal, Quebec, Canada, H2X 0A9
Contact: Fred Saad, Site 0066    514890800027466      
Canada
BC Cancer - Kelowna Recruiting
Kelowna, Canada, V1Y 5L3
Contact: Susan Ellard, Site 0067    2507123996      
CHU de Quebec - Universite Laval Recruiting
Quebec, Canada, G1R 2J6
Contact: Louis Lacombe, Site 0056         
Chile
Bradford Hill Centro de Investigaciones Clinicas Recruiting
Santiago de Chile, Metropolitana, Chile
Contact: Osvaldo Aren Frontera, Site 0034    +56225757247      
Instituto Oncologico Recruiting
Vina Del Mar, Valparaiso, Chile, 254 0364
Contact: Pablo Gonzalez Mella, Site 0051    5632324375      
Colombia
Local Institution Recruiting
Monteria, Cordoba, Colombia
Contact: Site 0027         
Local Institution Not yet recruiting
Bogota, Colombia
Contact: Site 0028         
Local Institution Recruiting
Medellin, Colombia, MEDELLIN
Contact: Site 0026         
France
Local Institution Recruiting
Besancon, France, 25030
Contact: Site 0033         
Local Institution Recruiting
Clermont-ferrand, France, 63000
Contact: Site 0032         
Local Institution Recruiting
Lyon, France, 69008
Contact: Site 0031         
Local Institution Recruiting
Marseille, France, 13273
Contact: Site 0030         
Local Institution Recruiting
Villejuif, France, 94805
Contact: Site 0029         
Germany
Universitaetsklinikum Essen Recruiting
Essen, Germany, 45122
Contact: Boris Hadaschik, Site 0001    +492017233699      
Universitaetsmedizin Goettingen Recruiting
Goettingen, Germany, 37075
Contact: Arne Strauss, Site 0006         
Uniklinik Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Carsten Gruellich, Site 0004         
Universitaetsklinikum Jena Recruiting
Jena, Germany, 07747
Contact: Marc-Oliver Grimm, Site 0002         
Praxisklinik Fuer Haematologie Und Onkologie Recruiting
Koblenz, Germany, 56068
Contact: Christoph Lutz, Site 0007         
Klinikum rechts der Isar der Technischen Universitat Munchen Recruiting
Munich, Germany, 81675
Contact: Margitta Retz, Site 0064    +498941402548      
Mexico
Local Institution Recruiting
Leon, Guanajuato, Mexico, 37000
Contact: Site 0054         
Local Institution Recruiting
Guadalajara, Jalisco, Mexico, 44130
Contact: Site 0061         
Local Institution Recruiting
Guadalajara, Jalisco, Mexico, 44280
Contact: Site 0048         
Local Institution Recruiting
Culiacan, Sinaloa, Mexico, 80230
Contact: Site 0025         
Spain
Local Institution Recruiting
Madrid, Spain, 28041
Contact: Site 0045         
Local Institution Recruiting
Pamplona, Spain, 31008
Contact: Site 0046         
Hospital Universitario Virgen Del Rocio Recruiting
Sevilla, Spain, 41013
Contact: Begona Perez Valderrama, Site 0047         
Sponsors and Collaborators
Bristol-Myers Squibb
Clovis Oncology, Inc.
Astellas Pharma Inc
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03338790     History of Changes
Other Study ID Numbers: CA209-9KD
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nivolumab
Rucaparib
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors