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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03338790
Recruitment Status : Active, not recruiting
First Posted : November 9, 2017
Last Update Posted : September 10, 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 : January 20, 2021
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Locations
Hide Hide 66 study locations
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United States, Alabama
Southern Cancer Center Pc
Daphne, Alabama, United States, 36526
United States, California
Desert Hematology Oncology Medical Group
Rancho Mirage, California, United States, 92270
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
Baptist Health Medical Group Oncology
Miami, Florida, United States, 33176
United States, Georgia
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, United States, 30060
United States, Kentucky
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
United States, Maryland
Maryland Oncology Hematology, P.A.
Rockville, Maryland, United States, 20850
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
United States, Mississippi
Jackson Oncology Associates, Pllc
Jackson, Mississippi, United States, 39202
United States, Missouri
Washington University School Of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
United States, New York
New York Oncology Hematology, P.C.
Amsterdam, New York, United States, 12010
Columbia University Medical Center (Cumc)
New York, New York, United States, 10032
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
United States, Virginia
Virginia Cancer Care Specialist, PC
Fairfax, Virginia, United States, 22031
Argentina
Hospital Militar Central
Caba, Buenos Aires, Argentina, 1426
Instituto Medico Especializado Alexander Fleming
Capital Federal, Buenos Aires, Argentina, 1426
Hospital Britanico De Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1280
Hospital Italiano De Buenos Aires
Caba, Argentina, 1199
Instituto Oncologico De Cordoba
Cordoba, Argentina, 5000
Australia, New South Wales
Chris O'Brien Lifehouse Hospital
Camperdown, New South Wales, Australia, 2050
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Integrated Clinical Oncology Network Pty Ltd (ICON)
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia, 5112
Australia, Victoria
Monash Medical Centre Clayton
Clayton, Victoria, Australia, 3168
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Brazil
Cetus Hospital Dia Oncologia
Belo Horizonte, Minas Gerais, Brazil, 30110-022
PERSONAL Oncologia de Precisao e Personalizada
Belo Horizonte, Minas Gerais, Brazil, 30130-090
CIONC
Curitiba, Parana, Brazil, 81480-580
Associacao Hospital de Caridade Ijui
Ijui, RIO Grande DO SUL, Brazil, 98700-000
Hospital Moinhos de Vento
Porto Alegre, RIO Grande DO SUL, Brazil, 90035-001
Radium Instituto de Oncologia
Campinas, SAO Paulo, Brazil, 13075-460
Instituto COI de Educacao e Pesquisa
Rio de Janeiro, Brazil, 22793-080
Hospital Sirio Libanes
Sao Paulo, Brazil, 01308-050
Local Institution
Sao Paulo, Brazil, 05651-901
Canada, British Columbia
BC Cancer - Kelowna
Kelowna, British Columbia, Canada, V1Y 5L3
Canada, New Brunswick
The Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
Juravinski Cancer Center
Hamilton, Ontario, Canada, L8V 5C2
Canada
Centre Hospitalier De L'Universite De Montreal
Montreal, Canada, H2X 0A9
CHU de Quebec - Universite Laval
Quebec, Canada, G1R 2J6
Chile
Centro de Investigacion Clinica Bradford Hill
Santiago de Chile, Metropolitana, Chile
Instituto Oncologico
Vina del Mar, Valparaiso, Chile, 2540364
Colombia
Local Institution
Monteria, Cordoba, Colombia
Local Institution
Medellin, Colombia, MEDELLIN
France
Chu Jean Minjoz
Besancon, France, 25030
Local Institution
Clermont-ferrand, France, 63000
Centre Leon Berard
Lyon, France, 69008
Local Institution
Marseille, France, 13273
Local Institution
Villejuif, France, 94805
Germany
Universitaetsklinikum Essen
Essen, Germany, 45122
Universitaetsmedizin Goettingen
Goettingen, Germany, 37075
Uniklinik Heidelberg
Heidelberg, Germany, 69120
Universitaetsklinikum Jena
Jena, Germany, 07747
Praxisklinik Fuer Haematologie Und Onkologie
Koblenz, Germany, 56068
Klinikum rechts der Isar der Technischen Universitat Munchen
Munich, Germany, 81675
Mexico
Local Institution
Leon, Guanajuato, Mexico, 37000
Local Institution
Guadalajara, Jalisco, Mexico, 44130
Local Institution
Guadalajara, Jalisco, Mexico, 44280
Local Institution
Culiacan, Sinaloa, Mexico, 80230
Spain
Local Institution
Madrid, Spain, 28041
Local Institution
Pamplona, Spain, 31008
Hosp. Univ. Virgen Del Rocio
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: September 10, 2020
Last Verified: September 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
Prostatic Diseases
Prednisone
Docetaxel
Nivolumab
Rucaparib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Immunological
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors