Pembrolizumab Phase 3 Trial for Bladder Cancer Completes Primary Data Collection

The Phase 3 KEYNOTE-B15 trial (NCT04700124), investigating pembrolizumab in combination with enfortumab vedotin for cisplatin-eligible muscle invasive bladder cancer (MIBC), reached its primary completion date on 2025-10-27. This milestone signifies the collection of all primary outcome data for the study.

Background

The study focuses on cisplatin-eligible muscle invasive bladder cancer (MIBC), a specific type of bladder cancer. The trial evaluates perioperative pembrolizumab in combination with enfortumab vedotin, against a comparator arm of neoadjuvant chemotherapy (gemcitabine plus cisplatin).

Trial design

The KEYNOTE-B15 / EV-304 study (NCT04700124) is a Phase 3, randomized trial that enrolled 808 participants. The study investigates treatments for cisplatin-eligible muscle invasive bladder cancer (MIBC). The trial compares perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) (Arm A) against neoadjuvant gemcitabine plus cisplatin and RC + PLND (Arm B). The primary hypothesis is that Arm A will achieve superior event-free survival (EFS) compared to Arm B.

What this means

The primary completion of the KEYNOTE-B15 trial marks a significant step towards understanding the potential efficacy and safety of perioperative enfortumab vedotin plus pembrolizumab for patients with cisplatin-eligible muscle invasive bladder cancer. With primary data collection now complete, researchers will proceed with data analysis to evaluate the trial's primary endpoint of event-free survival. The results of this Phase 3 study are anticipated to inform future treatment guidelines for MIBC.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT04700124, titled "Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)," was updated to reflect its primary completion date of 2025-10-27 on clinicaltrials.gov.