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  • JAVELIN Bladder 100

    Acronym: 

    ACTRN/NCT /ethics: 

    NCT02603432

    Scientific title: 

    A Phase 3, Multicenter, Multinational, Randomized, Open-label, Parallel-arm Study Of Avelumab (msb0010718c) Plus Best Supportive Care Versus Best Supportive Care Alone As A Maintenance Treatment In Patients With Locally Advanced Or Metastatic Urothelial Cancer Whose Disease Did Not Progress After Completion Of First-line Platinum-containing Chemotherapy

    Summary of trial and patient characteristics

    Cancer Type Bladder
    Trial Type Treatment
    Phase Phase III Tumour Stream Urothelial
    Age Range 18 years and older Cancer Stage Locally Recurrent or Locally Advanced, Metastatic or Widespread
    Sex Both Anticipated Start Date 2016-04-28
    Molecular Target Anticipated End Date 2020-07-24
    Cancer Type Bladder
    Trial Type Treatment
    Phase Phase III
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Urothelial
    Cancer Stage Locally Recurrent or Locally Advanced, Metastatic or Widespread
    Anticipated Start Date 2016-04-28
    Anticipated End Date 2020-07-24

    Trial Summary

    The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy.

    Lay Summary

    A Phase 3, Multicenter, Multinational, Randomized, Open-label, Parallel-arm Study Of Avelumab (msb0010718c) Plus Best Supportive Care Versus Best Supportive Care Alone As A Maintenance Treatment In Patients With Locally Advanced Or Metastatic Urothelial Cancer Whose Disease Did Not Progress After Completion Of First-line Platinum-containing Chemotherapy

    Sponsor / Cooperative group

    Pfizer

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Queen Elizabeth Hospital Sue Yeend Sue.Yeend@sa.gov.au 08 8222 6148 K Patterson Recruiting
    Flinders Medical Centre Alex Scott-Hoy alex.scott-hoy@sa.gov.au 08 8204 4830 Recruiting