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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 : February 25, 2020
Sponsor:
Collaborators:
Clovis Oncology, Inc.
Astellas Pharma Inc
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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

Study Design
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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

Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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

Contacts and Locations
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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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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
More Information
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Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site Investigator Inquiry Form  This link exits the ClinicalTrials.gov site FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

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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: February 25, 2020
Last Verified: February 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