The Phase 3 study, MK-3475-905/KEYNOTE-905/EV-303 (NCT03924895), investigating perioperative pembrolizumab or perioperative pembrolizumab plus enfortumab vedotin for muscle-invasive bladder cancer, reached primary completion on 2025-06-06. This milestone indicates that the final data for the primary outcome measure has been collected.

Background

This study focuses on participants with muscle-invasive bladder cancer (MIBC) who are either cisplatin-ineligible or decline cisplatin treatment. Pembrolizumab (Keytruda) is an immunotherapy drug that targets the PD-1 pathway, often used in various cancer types. The trial explores its use in a perioperative setting, meaning around the time of surgery, specifically radical cystectomy (RC) and pelvic lymph node dissection (PLND).

Trial design

The MK-3475-905/KEYNOTE-905/EV-303 study (NCT03924895) is a Phase 3 trial that enrolled 595 participants. The study investigates treatments for Urinary Bladder Cancer, Muscle-invasive. Interventions include pembrolizumab and enfortumab vedotin. The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy (RC) and pelvic lymph node dissection (PLND), and perioperative enfortumab vedotin in combination with pembrolizumab plus RC+PLND, will achieve superior event-free survival (EFS) compared with RC+PLND alone.

What this means

The primary completion of this Phase 3 trial signifies that all participants have completed the study according to the protocol for the primary outcome. This stage is crucial as it precedes the analysis of the collected data, which will determine if the investigational perioperative regimens involving pembrolizumab, alone or with enfortumab vedotin, demonstrate superior event-free survival compared to surgery alone for patients with muscle-invasive bladder cancer who are cisplatin-ineligible or decline cisplatin. The results, once available, will be important for guiding future treatment strategies in this patient population.

Source

Information regarding the primary completion of trial NCT03924895 was obtained from ClinicalTrials.gov, a public database of clinical studies. The event was recorded on 2025-06-06 on clinicaltrials.gov.