KEYNOTE-B15
22 Nov 2021
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 Type | Bladder |
|---|---|
| Trial Type | Treatment |
| Phase | Phase III |
| Age Range | 18 years and older |
| Sex | All |
| Tumour Stream | - |
| Cancer Stage | Locally Recurrent or Locally Advanced |
| Anticipated Start Date | 2021-04-21 |
| Anticipated End Date | 2026-06-23 |
Participating Hospitals
| Hospital | Lyell McEwin Hospital |
|---|---|
| Clinical Trial Coordinator | Andy Phay |
| andy.phay@sa.gov.au | |
| Phone | 08 8282 0833 |
| Principal Investigator | Dr Christopher Hocking |
| Recruitment Status | Recruiting |