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  • EV-301

    Acronym: 

    EV-301

    ACTRN/NCT /ethics: 

    NCT03474107

    Scientific title: 

    An open-label randomised phase III study to evaluate enfortumab vedotin vs. chemotherapy in subjects with previously treated locally advanced or metastatic urothelial cancer.

    Summary of trial and patient characteristics

    Cancer Type Bladder
    Trial Type Treatment
    Phase Phase III Tumour Stream Bladder
    Age Range 18 years and older Cancer Stage Locally Recurrent or Locally Advanced, Metastatic or Widespread
    Sex Both Anticipated Start Date 2018-06-27
    Molecular Target Anticipated End Date 2021-09-01
    Cancer Type Bladder
    Trial Type Treatment
    Phase Phase III
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Bladder
    Cancer Stage Locally Recurrent or Locally Advanced, Metastatic or Widespread
    Anticipated Start Date 2018-06-27
    Anticipated End Date 2021-09-01

    Trial Summary

    The purpose of this study is to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy. This study will also compare progression-free survival on study therapy (PFS1); the overall response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 of participants treated with EV to participants treated with chemotherapy. In addition, this study will evaluate the duration of response (DOR) per RECIST V1.1 of EV and chemotherapy and assess the safety and tolerability of EV, as well as, the quality of life (QOL) and Patient Reported Outcomes (PRO) parameters.

    Lay Summary

    An open-label randomised phase III study to evaluate enfortumab vedotin vs. chemotherapy in subjects with previously treated locally advanced or metastatic urothelial cancer.

    Sponsor / Cooperative group

    Astellas

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Royal Adelaide Hospital Anne Milton anne.milton@sa.gov.au 08 7074 2342 Dr Hsiang Tan Recruiting