Clinical Trials /

An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer

NCT02632409

Description:

The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.

Related Conditions:
  • Urothelial Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer
  • Official Title: A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)

Clinical Trial IDs

  • ORG STUDY ID: CA209-274
  • SECONDARY ID: 2014-003626-40
  • NCT ID: NCT02632409

Conditions

  • Various Advanced Cancer

Interventions

DrugSynonymsArms
NivolumabNivolumab

Purpose

The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.

Trial Arms

NameTypeDescriptionInterventions
NivolumabExperimentalNivolumab dose as specified
    PlaceboPlacebo ComparatorPlacebo dose as specified

      Eligibility Criteria

              For more information regarding BMS clinical trial participation, please visit
              www.BMSStudyConnect.com
      
              Inclusion Criteria:
      
                -  Must have had invasive urothelial cancer at high risk of recurrence originating in
                   the bladder, ureter, or renal pelvis
      
                -  Must have had radical surgical resection (e.g. radical cystectomy), performed within
                   the last 90 days
      
                -  Must have disease free status as determined by imaging within 4 weeks of dosing
      
                -  Tumor tissue must be provided for biomarker analysis
      
                -  Patients who have not received prior neoadjuvant cisplatin chemotherapy must be
                   ineligible for or refuse cisplatin-based adjuvant chemotherapy
      
              Exclusion Criteria:
      
                -  Partial bladder or kidney removal (eg, partial cystectomy)
      
                -  Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following
                   surgical removal of bladder cancer
      
                -  Subjects with active, known or suspected autoimmune disease
      
                -  Prior malignancy active within the previous 3 years except for locally curable
                   cancers that have been apparently cured
      
                -  Condition requiring systemic treatment with either corticosteroids or other
                   immunosuppressive medications within 14 day of study drug administration
      
                -  Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus
                   ribonucleic acid (HCV antibody) indicating acute or chronic infection
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Disease free survival (DFS)
      Time Frame:Approximately 5 years after the first subject is randomized
      Safety Issue:
      Description:DFS defined as the time between the date of randomization and the date of first recurrence or death (of any cause) whichever occurs first.

      Secondary Outcome Measures

      Measure:Non-Urothelial track recurrence free survival (NUTRFS)
      Time Frame:Approximately 5 years after the first subject is randomized
      Safety Issue:
      Description:NUTRFS is defined as the time between the date of randomization and the date of first local non urothelial tract or distant recurrence or death (of any cause), whichever occurs first.
      Measure:Disease specific survival (DSS)
      Time Frame:Approximately 5 years after the first subject is randomized
      Safety Issue:
      Description:DSS is defined the time between the date of randomization and the date of death due to disease (urothelial cancer).
      Measure:Overall survival (OS)
      Time Frame:Approximately 5 years after the first subject is randomized
      Safety Issue:
      Description:OS is defined as the time between the date of randomization and the date of death (of any cause).

      Details

      Phase:Phase 3
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Bristol-Myers Squibb

      Last Updated

      April 18, 2017