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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)

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ClinicalTrials.gov Identifier: NCT03338790
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : December 2, 2019
Sponsor:
Collaborators:
Clovis Oncology, Inc.
Astellas Pharma Inc
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE November 8, 2017
First Posted Date  ICMJE November 9, 2017
Last Update Posted Date December 2, 2019
Actual Study Start Date  ICMJE December 15, 2017
Estimated Primary Completion Date November 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2019)
  • Objective Response Rate (ORR) [ Time Frame: Approximately 12 months ]
  • Prostate-specific antigen response rate (RR-PSA) [ Time Frame: Approximately 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
  • Objective Response Rate (ORR) [ Time Frame: Approximately 12 months ]
    Assessed per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
  • 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
Change History Complete list of historical versions of study NCT03338790 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2019)
  • Radiographic progression-free survival (rPFS) [ Time Frame: Approximately 12 months ]
  • Time to response (TTR) [ Time Frame: Approximately 12 months ]
  • Duration of response (DOR) [ Time Frame: Approximately 12 months ]
  • Time to prostate-specific antigen progression (TTP-PSA) [ Time Frame: Approximately 12 months ]
  • Overall Survival (OS) [ Time Frame: Up to 5 years ]
  • Incidence of adverse events (AEs) [ Time Frame: Approximately 12 months ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Approximately 12 months ]
  • Incidence of AEs leading to discontinuation [ Time Frame: Approximately 12 months ]
  • Incidence of immune-mediated AEs [ Time Frame: Approximately 12 months ]
  • Incidence of deaths [ Time Frame: Approximately 12 months ]
  • Incidence of Laboratory Abnormalities [ Time Frame: Approximately 12 months ]
  • Number of clinically significant changes in lab assessment of blood [ Time Frame: Approximately 12 months ]
  • Number of clinically significant changes in lab assessment of blood serum [ Time Frame: Approximately 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
  • Radiographic progression-free survival (rPFS) [ Time Frame: Approximately 12 months ]
    Assessed per PCWG3
  • Time to response (TTR) [ Time Frame: Approximately 12 months ]
    Assessed per PCWG3
  • Duration of response (DOR) [ Time Frame: Approximately 12 months ]
    Assessed per PCWG3
  • Time to prostate-specific antigen progression (TTP-PSA) [ Time Frame: Approximately 12 months ]
    Assessed per PCWG3
  • Overall Survival (OS) [ Time Frame: Up to 5 years ]
    Time between treatment initiation and the date of death from any cause
  • Incidence of adverse events (AEs) [ Time Frame: Approximately 12 months ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Approximately 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Official Title  ICMJE A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Biological: nivolumab
    Specified dose on specified days
    Other Name: BMS-936558, Opdivo
  • Drug: docetaxel
    Specified dose on specified days
  • Drug: enzalutamide
    Specified dose on specified days
  • Drug: rucaparib
    Specified dose on specified days
  • Drug: prednisone
    Specified dose on specified days
Study Arms  ICMJE
  • Experimental: nivolumab + rucaparib
    Specified dose on specified days
    Interventions:
    • Biological: nivolumab
    • Drug: rucaparib
  • Experimental: nivolumab + docetaxel + prednisone
    Specified dose on specified days
    Interventions:
    • Biological: nivolumab
    • Drug: docetaxel
    • Drug: prednisone
  • Experimental: nivolumab + enzalutamide
    Specified dose on specified days
    Interventions:
    • Biological: nivolumab
    • Drug: enzalutamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 9, 2018)
330
Original Estimated Enrollment  ICMJE
 (submitted: November 8, 2017)
300
Estimated Study Completion Date  ICMJE November 18, 2021
Estimated Primary Completion Date November 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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 #.
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Canada,   Chile,   Colombia,   France,   Germany,   Mexico,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03338790
Other Study ID Numbers  ICMJE CA209-9KD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE
  • Clovis Oncology, Inc.
  • Astellas Pharma Inc
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP