Clinical Trials /

A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer

NCT04100018

Description:

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

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CA209-7DX
  • NCT ID: NCT04100018

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
nivolumabArm A: (nivolumab + docetaxel + prednisone)
prednisoneArm A: (nivolumab + docetaxel + prednisone)
docetaxelArm A: (nivolumab + docetaxel + prednisone)

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Arm A: (nivolumab + docetaxel + prednisone)Experimental
  • nivolumab
  • prednisone
  • docetaxel
Arm B: (placebo + docetaxel + prednisone)Active Comparator
  • prednisone
  • docetaxel

Eligibility 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 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG3)
Time Frame:Approxmiately 2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective Response Rate (ORR) per Prostate Cancer Working Group (PCWG3)
Time Frame:Approxmiately 3 years
Safety Issue:
Description:
Measure:Duration of response (DOR) per Prostate Cancer Working Group (PCWG3)
Time Frame:Approxmiately 3 years
Safety Issue:
Description:
Measure:PSA Response Rate (PSA-RR)
Time Frame:Approxmiately 3 years
Safety Issue:
Description:
Measure:Time to Response per PCWG3 (TTR-PCWG3) assessed by BICR
Time Frame:Approxmiately 3 years
Safety Issue:
Description:
Measure:Time to pain progression
Time Frame:Approxmiately 3 years
Safety Issue:
Description:
Measure:Time to PSA Progression (TTP-PSA)
Time Frame:Approxmiately 3 years
Safety Issue:
Description:
Measure:Incidence of AEs (Adverse Events)
Time Frame:Approxmiately 3 years
Safety Issue:
Description:
Measure:Incidence of SAEs ( Serious Adverse Events)
Time Frame:Approxmiately 3 years
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Bristol-Myers Squibb

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