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Trial Summary

The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible.

Acronym:

KEYNOTE-B15

ACTRN/NCT /ethics:

NCT04700124

Scientific title:

A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants with Muscleinvasive Bladder Cancer

Sponsor / Cooperative group:

Merck Sharp & Dohme Corp.

Trial & Patient Characteristics

Cancer TypeBladder
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexBoth
Tumour Stream -
Cancer StageLocally Recurrent or Locally Advanced
Anticipated Start Date2021-04-21
Anticipated End Date2026-06-23

Participating Hospitals

HospitalLyell McEwin Hospital
Clinical Trial CoordinatorAndy Phay
Emailandy.phay@sa.gov.au
Phone08 8282 0833
Principal InvestigatorDr Christopher Hocking
Recruitment StatusRecruiting