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

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ClinicalTrials.gov Identifier: NCT04100018
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to test 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: Double (Participant, Investigator)
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 : December 6, 2019
Estimated Primary Completion Date : March 19, 2024
Estimated Study Completion Date : July 6, 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: 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 2 years ]
  2. Overall Survival (OS) [ Time Frame: From the date of randomization to the date of death from any cause, approximately 3 years. 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 3 years ]
  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 3 years ]
  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 3 years ]
  4. Prostate-specific antigen (PSA) Response Rate (PSA-RR) [ Time Frame: Approximately 3 years ]
  5. Time to PSA Progression (TTP-PSA) [ Time Frame: From date of randomization to the date of PSA progression per PCWG3, approximately 3 years ]
  6. Incidence of Adverse Events (AEs) [ Time Frame: Approximately 3 years ]
  7. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Approximately 3 years ]
  8. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 3 years ]
  9. Incidence of immune-mediated AEs [ Time Frame: Approximately 3 years ]
  10. Incidence of deaths [ Time Frame: Approximately 3 years ]
  11. Incidence of laboratory abnormalities [ Time Frame: Approximately 3 years ]
  12. Median time to pain progression assessed by Brief Pain Inventory-Short Form (BPI-SF) [ Time Frame: Approximately 3 years ]

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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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
  • Sufficient tumor samples from either a fresh biopsy (obtained during screening) or archival tumor tissue in the form of formalin-fixed paraffin-embedded (FFPE) block or unstained tumor tissue slides
  • Men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

  • Prior malignancy active within the previous 3 years (i.e. participants with a history of prior malignancy are eligible if treatment was completed at least 3 years before enrollment) 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
  • 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: 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
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: November 19, 2020
Last Verified: November 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
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