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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 27, 2020
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 : November 19, 2020
Estimated Study Completion Date : November 18, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: nivolumab + rucaparib
Specified dose on specified days
Biological: nivolumab
Specified dose on specified days
Other Name: 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 Name: 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 Name: BMS-936558, Opdivo

Drug: enzalutamide
Specified dose on specified days




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Approximately 12 months ]
  2. Prostate-specific antigen response rate (RR-PSA) [ Time Frame: Approximately 12 months ]

Secondary Outcome Measures :
  1. Radiographic progression-free survival (rPFS) [ Time Frame: Approximately 12 months ]
  2. Time to response (TTR) [ Time Frame: Approximately 12 months ]
  3. Duration of response (DOR) [ Time Frame: Approximately 12 months ]
  4. Time to prostate-specific antigen progression (TTP-PSA) [ Time Frame: Approximately 12 months ]
  5. Overall Survival (OS) [ Time Frame: Up to 5 years ]
  6. Incidence of adverse events (AEs) [ Time Frame: Approximately 12 months ]
  7. Incidence of serious adverse events (SAEs) [ Time Frame: Approximately 12 months ]
  8. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 12 months ]
  9. Incidence of immune-mediated AEs [ Time Frame: Approximately 12 months ]
  10. Incidence of deaths [ Time Frame: Approximately 12 months ]
  11. Incidence of Laboratory Abnormalities [ Time Frame: Approximately 12 months ]
  12. Number of clinically significant changes in lab assessment of blood [ Time Frame: Approximately 12 months ]
  13. Number of clinically significant changes in lab assessment of blood serum [ Time Frame: Approximately 12 months ]


Information from the National Library of Medicine

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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 #.

Locations
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United States, Alabama
Southern Cancer Center Pc Active, not recruiting
Daphne, Alabama, United States, 36526
United States, California
Desert Hematology Oncology Medical Group Active, not recruiting
Rancho Mirage, California, United States, 92270
Local Institution Withdrawn
San Francisco, California, United States, 94158
United States, Connecticut
Yale University School Of Medicine Active, not recruiting
New Haven, Connecticut, United States, 06520
United States, Florida
Baptist Health Medical Group Oncology Completed
Miami, Florida, United States, 33176
United States, Georgia
Northwest Georgia Oncology Centers, P.C. Active, not recruiting
Marietta, Georgia, United States, 30060
United States, Kentucky
Norton Cancer Institute Active, not recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane University Active, not recruiting
New Orleans, Louisiana, United States, 70112
United States, Maryland
Maryland Oncology Hematology, P.A. Active, not recruiting
Rockville, Maryland, United States, 20850
United States, Massachusetts
Boston Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02118
United States, Michigan
Karmanos Cancer Center Active, not recruiting
Detroit, Michigan, United States, 48201
United States, Minnesota
Local Institution Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Site 0076         
United States, Mississippi
Jackson Oncology Associates, Pllc Completed
Jackson, Mississippi, United States, 39202
United States, Missouri
Washington University School Of Medicine Active, not recruiting
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Oncology Hematology West P.C. dba Nebraska Cancer Specialists Active, not recruiting
Omaha, Nebraska, United States, 68130
United States, New York
New York Oncology Hematology, P.C. Active, not recruiting
Amsterdam, New York, United States, 12010
Columbia University Medical Center (Cumc) Active, not recruiting
New York, New York, United States, 10032
United States, North Carolina
Duke University Active, not recruiting
Durham, North Carolina, United States, 27710
United States, Oregon
Providence Portland Medical Center Active, not recruiting
Portland, Oregon, United States, 97213
United States, Pennsylvania
Lehigh Valley Health Network Active, not recruiting
Allentown, Pennsylvania, United States, 18103
United States, Virginia
Virginia Cancer Care Specialist, PC Active, not recruiting
Fairfax, Virginia, United States, 22031
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    +541132218956      
Hospital Britanico De Buenos Aires Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1280
Contact: Ernesto Korbenfeld, Site 0044    541163819972      
Hospital Italiano De Buenos Aires Recruiting
Caba, Argentina, 1199
Contact: Jose Minatta, Site 0043    +541149590200      
Instituto Oncologico De Cordoba Recruiting
Cordoba, Argentina, 5000
Contact: Martin Richardet, Site 0062    +543514601544      
Australia, New South Wales
Chris O'Brien Lifehouse Hospital 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, South Australia
Lyell McEwin Hospital Recruiting
Elizabeth Vale, South Australia, Australia, 5112
Contact: Christopher Hocking, Site 0016    +61882820833      
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      
Brazil
Cetus Hospital Dia Oncologia Active, not recruiting
Belo Horizonte, Minas Gerais, Brazil, 30110-022
PERSONAL Oncologia de Precisao e Personalizada Active, not recruiting
Belo Horizonte, Minas Gerais, Brazil, 30130-090
CIONC Active, not recruiting
Curitiba, Parana, Brazil, 81480-580
Associacao Hospital de Caridade Ijui Active, not recruiting
Ijui, RIO Grande DO SUL, Brazil, 98700-000
Hospital Moinhos de Vento Recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90035-001
Contact: Sergio Roithmann, Site 0021    +555133143693      
Radium Instituto de Oncologia Active, not recruiting
Campinas, SAO Paulo, Brazil, 13075-460
Instituto COI de Educacao e Pesquisa Active, not recruiting
Rio de Janeiro, Brazil, 22793-080
Local Institution Withdrawn
Santa Catarina, Brazil, 89812-021
Hospital Sirio Libanes Active, not recruiting
Sao Paulo, Brazil, 01308-050
Local Institution Active, not recruiting
Sao Paulo, Brazil, 05651-901
Canada, Alberta
Local Institution Withdrawn
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BC Cancer - Kelowna Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Susan Ellard, Site 0067    2507123996      
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
Centre Hospitalier De L'Universite De Montreal Recruiting
Montreal, Canada, H2X 0A9
Contact: Fred Saad, Site 0066    514890800027466      
CHU de Quebec - Universite Laval Recruiting
Quebec, Canada, G1R 2J6
Contact: Louis Lacombe, Site 0056         
Chile
Bradford Hill Centro de Investigacion Clinica Recruiting
Santiago de Chile, Metropolitana, Chile
Contact: Mauricio Burotto, Site 0034    +56225757247      
Instituto Oncologico Recruiting
Vina Del Mar, Valparaiso, Chile, 254 0364
Contact: Pablo Gonzalez Mella, Site 0051    +56322891219      
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
Chu Jean Minjoz Recruiting
Besancon, France, 25030
Contact: Antoine Thiery-Vuillemin, Site 0033         
Local Institution Recruiting
Clermont-ferrand, France, 63000
Contact: Site 0032         
Centre Leon Berard Recruiting
Lyon, France, 69008
Contact: Aude Flechon, Site 0031         
Local Institution Recruiting
Marseille, France, 13273
Contact: Site 0030         
Local Institution Recruiting
Villejuif, France, 94805
Contact: Site 0029         
Germany
Universitaetsklinikum Essen Completed
Essen, Germany, 45122
Universitaetsmedizin Goettingen Active, not recruiting
Goettingen, Germany, 37075
Uniklinik Heidelberg Active, not recruiting
Heidelberg, Germany, 69120
Universitaetsklinikum Jena Completed
Jena, Germany, 07747
Praxisklinik Fuer Haematologie Und Onkologie Active, not recruiting
Koblenz, Germany, 56068
Klinikum rechts der Isar der Technischen Universitat Munchen Active, not recruiting
Munich, Germany, 81675
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 Terminated
Madrid, Spain, 28041
Local Institution Terminated
Pamplona, Spain, 31008
Hosp. Univ. Virgen Del Rocio Terminated
Sevilla, Spain, 41013
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    
Other Study ID Numbers: CA209-9KD
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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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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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel
Nivolumab
Rucaparib
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