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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 : August 28, 2018
Sponsor:
Collaborators:
Clovis Oncology
Astellas Pharma Inc
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine which combination of Nivolumab plus either Rucaparib, Docetaxel, or Enzalutamide is the most effective in treating 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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 metastatic disease
  • Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
  • Mandatory 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
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 #.

  Show 74 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Clovis Oncology
Astellas Pharma Inc
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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: August 28, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nivolumab
Rucaparib
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Prednisone
Antibodies, Monoclonal
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
Immunologic Factors
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors