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Trial 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.

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.

Sponsor / Cooperative group:

Astellas

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.

Trial & Patient Characteristics

Cancer TypeBladder
Trial TypeTreatment
PhasePhase III
Age Range18+ years
SexBoth
Tumour StreamBladder
Cancer StageLocally Recurrent or Locally Advanced, Metastatic or Widespread
Anticipated Start Date2018-06-27
Anticipated End Date2021-09-01

Participating Hospitals

HospitalRoyal Adelaide Hospital
Clinical Trial CoordinatorAnne Milton
Emailanne.milton@sa.gov.au
Phone08 7074 2342
Principal InvestigatorDr Hsiang Tan
Recruitment StatusRecruiting