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A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer (CheckMate 7DX)

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: NCT04100018
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : March 30, 2023
Sponsor:
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 effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: Nivolumab Drug: Prednisone Drug: Docetaxel Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 984 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-Blinded
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer
Actual Study Start Date : February 6, 2020
Estimated Primary Completion Date : April 1, 2026
Estimated Study Completion Date : August 30, 2028

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: Arm A: Nivolumab + docetaxel + prednisone Biological: Nivolumab
Specified dose on specified days
Other Names:
  • OPDIVO,
  • BMS-936558-01

Drug: Prednisone
Specified dose on specified days

Drug: Docetaxel
Specified dose on specified days
Placebo Comparator: Arm B: Placebo + docetaxel + prednisone Drug: Prednisone
Specified dose on specified days

Drug: Docetaxel
Specified dose on specified days

Other: Placebo
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Radiographic progressive free survival (rPFS) assessed by Blinded Independent Central Review (BICR) per Prostate Cancer Working Group (PCWG3) [ Time Frame: From the date of randomization to the first date of documented progression or death due to any cause, whichever occurs first, approximately 31 months ]
    Up to 530 rPFS events

  2. Overall Survival (OS) [ Time Frame: From the date of randomization to the date of death from any cause, approximately 51 months. For participants who are alive, their survival time will be censored at the last date that they were known to be alive ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) per PCWG3 [ Time Frame: From the date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first, approximately 31 months ]
  2. Time to Response per PCWG3 (TTR-PCWG3) determined by BICR [ Time Frame: From the date of randomization to the date of the first documented complete response (CR) or partial response (PR), approximately 31 months ]
  3. Duration of Response (DOR) per PCWG3 determined by BICR [ Time Frame: From the date of first response (CR/PR) to the date of first documented radiographic progression, or death due to any cause, approximately 31 months ]
  4. Prostate-specific antigen (PSA) Response Rate (PSA-RR) [ Time Frame: Approximately 31 months ]
  5. Time to PSA Progression (TTP-PSA) [ Time Frame: From date of randomization to the date of PSA progression per PCWG3, approximately 31 months ]
  6. Incidence of Adverse Events (AEs) [ Time Frame: Approximately 31 months ]
  7. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Approximately 31 months ]
  8. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 31 months ]
  9. Incidence of immune-mediated AEs [ Time Frame: Approximately 31 months ]
  10. Incidence of deaths [ Time Frame: Approximately 31 months ]
  11. Incidence of laboratory abnormalities: Clinical Chemistry Tests [ Time Frame: Approximately 31 months ]
  12. Incidence of laboratory abnormalities: Hematology tests [ Time Frame: Approximately 31 months ]
  13. Incidence of laboratory abnormalities: Serology tests [ Time Frame: Approximately 31 months ]
  14. Median time to pain progression assessed by Brief Pain Inventory-Short Form (BPI-SF) [ Time Frame: Approximately 31 months ]
  15. Incidence of changes from baseline in Physical Exam [ Time Frame: Approximately 31 months ]
  16. Incidence of changes from baseline in vital signs: Respiratory rate [ Time Frame: Approximately 31 months ]
  17. Incidence of changes from baseline in vital signs: Body temperature [ Time Frame: Approximately 31 months ]
  18. Incidence of changes from baseline in vital signs: Blood pressure [ Time Frame: Approximately 31 months ]
  19. Incidence of changes from baseline in vital signs: Heart Rate [ Time Frame: Approximately 31 months ]
  20. Incidence of changes from baseline electrocardiogram (ECG) [ Time Frame: Approximately 31 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic confirmation of adenocarcinoma of the prostate without small cell features
  • Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
  • Documented prostate cancer progression per Prostate Cancer Working Group (PCWG3) criteria within 6 months prior to screening
  • Chemotherapy-naïve for metastatic castration-resistant prostate cancer (mCRPC), with 1 to 2 prior second generation hormonal therapies in the recurrent non-metastatic setting and/or metastatic setting, and no more than 1 second generation hormonal therapy in the mCRPC setting. Must have progressed during or after second generation hormonal therapy or have documented intolerance to second generation hormonal therapy
  • Participants must meet one of the following criteria regarding tissue submission: Sufficient tumor samples from a newly obtained ("fresh") biopsy (obtained during screening); or archival tumor tissue in the form of formalin-fixed paraffin-embedded (FFPE) block or unstained tumor tissue slides. For participants with bone-only disease or inaccessible soft tissue lesions or if the biopsy procedure would pose an unacceptable clinical risk for the participant, submission of tumor tissue obtained from a fresh biopsy is not required.
  • Men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

  • Active brain metastases
  • Active, known, or suspected autoimmune disease
  • Condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids or adrenal replacement steroid doses are permitted in the absence of active autoimmune disease
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Prior treatment with docetaxel or other chemotherapy for mCRPC. Prior docetaxel for metastatic castration-sensitive prostate cancer is permitted if at least 12 months have elapsed from last dose of docetaxel

Other protocol-defined inclusion/exclusion criteria 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): NCT04100018


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 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
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04100018    
Other Study ID Numbers: CA209-7DX
2019-002030-36 ( EudraCT Number )
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: March 30, 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
Prostatic Diseases
Prednisone
Docetaxel
Nivolumab
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