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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 : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE September 20, 2019
First Posted Date  ICMJE September 23, 2019
Last Update Posted Date November 26, 2019
Estimated Study Start Date  ICMJE December 16, 2019
Estimated Primary Completion Date February 20, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2019)
  • Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG3) [ Time Frame: Approxmiately 2 years ]
  • Overall Survival (OS) [ Time Frame: Approxmiately 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04100018 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2019)
  • Objective Response Rate (ORR) per Prostate Cancer Working Group (PCWG3) [ Time Frame: Approxmiately 3 years ]
  • Duration of response (DOR) per Prostate Cancer Working Group (PCWG3) [ Time Frame: Approxmiately 3 years ]
  • PSA Response Rate (PSA-RR) [ Time Frame: Approxmiately 3 years ]
  • Time to Response per PCWG3 (TTR-PCWG3) assessed by BICR [ Time Frame: Approxmiately 3 years ]
  • Time to pain progression [ Time Frame: Approxmiately 3 years ]
  • Time to PSA Progression (TTP-PSA) [ Time Frame: Approxmiately 3 years ]
  • Incidence of AEs (Adverse Events) [ Time Frame: Approxmiately 3 years ]
  • Incidence of SAEs ( Serious Adverse Events) [ Time Frame: Approxmiately 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer
Official Title  ICMJE A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Biological: nivolumab
    specified dose on specified days
  • Drug: prednisone
    specified dose on specified days
  • Drug: docetaxel
    specified dose on specified days
Study Arms  ICMJE
  • Experimental: Arm A: (nivolumab + docetaxel + prednisone)
    Interventions:
    • Biological: nivolumab
    • Drug: prednisone
    • Drug: docetaxel
  • Active Comparator: Arm B: (placebo + docetaxel + prednisone)
    Interventions:
    • Drug: prednisone
    • Drug: docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 20, 2019)		 984
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 14, 2024
Estimated Primary Completion Date February 20, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Inclusion Criteria:

  • Histologic confirmation of adenocarcinoma of the prostate and evidence of stage IV disease
  • Must have ECOG performance status 0-1
  • Documented prostate cancer progression per PCWG3 criteria within 6 months prior to screening
  • Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
  • Participants who are chemotherapy-naive and received 1 to 2 prior second generation hormonal therapies
  • Sufficient tumor sample from fresh or archival tumor tissue obtained no more than 1 year prior to enrollment, from a metastatic lesion or primary tumor lesion that has not been previously irradiated

Exclusion Criteria:

  • Participants with active brain metastases
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
  • Participants with an active, known, or suspected autoimmune disease
  • Participants requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications
  • Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or any antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Prior treatment with docetaxel or another chemotherapy for metastatic castration resistant prostate cancer

Other protocol defined inclusion/exclusion criteria could apply
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   China,   Czechia,   France,   Germany,   Hong Kong,   Israel,   Italy,   Korea, Republic of,   Mexico,   New Zealand,   Poland,   Romania,   Russian Federation,   Singapore,   Spain,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04100018
Other Study ID Numbers  ICMJE CA209-7DX
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bristol-Myers Squibb
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP