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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
Results First Posted : February 9, 2022
Last Update Posted : March 16, 2023
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)
Actual Enrollment : 292 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 19, 2017
Actual Primary Completion Date : January 13, 2021
Estimated Study Completion Date : June 28, 2024

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 Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3) [ Time Frame: Up to approximately 36 months ]
    Objective response rate per prostate cancer clinical trials working group 3 (ORR-PCWG3) for target lesions and assessed by MRI is the percentage of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among treated participants who have measurable disease

  2. Prostate-Specific Antigen Response Rate (RR-PSA) [ Time Frame: Up to approximately 36 months ]
    Prostate-specific antigen response rate (RR-PSA) is the percentage 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: Up to approximately 36 months ]
    Radiographic progress-free survival (rPFS) is the time between treatment initiation and the first date of documented progression or death due to any cause, whichever occurs first assessed by the investigator per PCWG3

  2. Time to Response Per Prostate Cancer Clinical Trials Working Group 3 (TTR-PCWG3) [ Time Frame: Up to approximately 36 months ]
    Time to response per prostate cancer clinical trials working group 3 (TTR-PCWG3) is the time from treatment initiation to the date of the first documented complete response (CR) or partial response (PR) per PCWG3

  3. Duration of Response Per Prostate Cancer Clinical Trials Working Group 3 (DOR-PCWG3) [ Time Frame: Up to approximately 36 months ]
    Duration of response per prostate cancer clinical trials working group 3 (DOR-PCWG3) is the time between the date of first response (complete response/partial response per PCWG3) to the date of first documented radiographic progression per PCWG3 or death due to any cause

  4. Prostate-Specific Antigen Time to Progression (TTP-PSA) [ Time Frame: Up to approximately 36 months ]
    Prostate-specific antigen time to progression (TTP-PSA) is the time between treatment initiation to the date of PSA progression per prostate cancer clinical trails working group 3

  5. Overall Survival (OS) [ Time Frame: Up to approximately 36 months ]
    Overall Survival (OS) is the time between treatment initiation and the date of death from any cause. For participants who are alive, their survival time will be censored at the last date that they were known to be alive. OS will be censored for participants at the date of treatment initiation if they had no follow-up

  6. Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose to up to 30 days post last dose (Up to 34 months) ]
    Number of Participants with any grade adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and immune-mediated AEs using the Common Toxicity Criteria Grade for Adverse Events (CTCAE V4)

  7. Number of Deaths [ Time Frame: Up to 36 months ]
    Number of deaths in all treated participants

  8. Number of Participants With Laboratory Abnormalities in Specific Liver Tests [ Time Frame: From first dose to up to 30 days post last dose (up to 34 months) ]

    Number of participants with laboratory abnormalities in specific liver tests based on SI conventional units to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:

    • ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN
    • Total bilirubin > 2 x ULN
    • ALP > 1.5 x ULN
    • Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN
    • Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN
    • Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
    • Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN

  9. Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests [ Time Frame: From first dose to up to 30 days post last dose (Up to 34 months) ]

    Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:

    • TSH value > ULN and
    • with baseline TSH value <= ULN
    • with at least one FT3/FT4 test value < LLN within 2-week window after the abnormal TSH test
    • with all FT3/FT4 test values >= LLN within 2-week window after the abnormal TSH test
    • with FT3/FT4 missing within 2-week window after the abnormal TSH test.
    • TSH < LLN and
    • with baseline TSH value >= LLN
    • with at least one FT3/FT4 test value > ULN within 2-week window after the abnormal TSH test
    • with all FT3/FT4 test values <= ULN within 2-week window after the abnormal TSH test
    • with FT3/FT4 missing within 2-week window after the abnormal TSH test

  10. Number of Participants With Laboratory Values Change From Baseline [ Time Frame: From first dose to up to 30 days post last dose (Up to 34 months) ]
    Number of participants changed from baseline in laboratory values of worst toxicity grade (grade 0= wnl, grade 1= mild, grade 2= moderate, grade 3= severe) based on US conventional units by cohort


Eligibility Criteria
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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

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


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
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] August 8, 2019
Statistical Analysis Plan  [PDF] December 19, 2019

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Results First Posted: February 9, 2022
Last Update Posted: March 16, 2023
Last Verified: March 2023

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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
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital 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
Immune Checkpoint Inhibitors
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors