KEYNOTE-905 (EV-303): NCT03924895: Phase 3: Periop Pembro + Cystectomy or Periop Pembro + Enfortumab Vedotin + Cystectomy Versus Cystectomy Alone in (Cis ineligible) Muscle-invasive Bladder Cancer

First Posted	2019-04-23
Trial status	Active, not recruiting
Sponsor	Merck Sharp & Dohme LLC
Abstract Presentation	Phase 3 KEYNOTE-905/EV-303: Perioperative pembrolizumab (pembro) or pembro + enfortumab vedotin (EV) for muscle-invasive bladder cancer (MIBC). 2023 ASCO Genitourinary Cancers Symposium Click here for details Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase III KEYNOTE-905 study ESMO - Sat, 18.10.2025 Click here for details
Press Release	KEYTRUDA® (pembrolizumab) plus Padcev® (enfortumab vedotin-ejfv) Significantly Improved Event-Free and Overall Survival and Pathologic Complete Response Rate for Certain Patients with Muscle-Invasive Bladder Cancer When Given Before and After Surgery August 12, 2025 Click here for details PADCEV™ Plus KEYTRUDA™ Significantly Improves Survival for Certain Patients with Bladder Cancer When Given Before and After Surgery Tuesday, August 12, 2025 Click here for details U.S. FDA Approves PADCEV® plus Keytruda® for Certain Patients with Bladder Cancer November 25, 2025 Click here for details
Peer-reviewed journal publication
FDA	FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer November 21, 2025 Click here for details
NCCN	BLA77

KEYNOTE-905 (EV-303): NCT03924895: Phase 3: Periop Pembro + Cystectomy or Periop Pembro + Enfortumab Vedotin + Cystectomy Versus Cystectomy Alone in (Cis ineligible) Muscle-invasive Bladder Cancer

Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/​KEYNOTE-905/​EV-303)

Official Title:

A Randomized Phase 3 Study Evaluating Cystectomy With Perioperative Pembrolizumab and Cystectomy With Perioperative Enfortumab Vedotin and Pembrolizumab Versus Cystectomy Alone in Participants Who Are Cisplatin-Ineligible or Decline Cisplatin With Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)

Intervention / Treatment:

Drug: Pembrolizumab

Procedure: Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])

Drug: Enfortumab Vedotin

Other Study ID Numbers:

3475-905

MK-3475-905 ( Other Identifier ) (OTHER: MSD)

KEYNOTE-905 ( Other Identifier ) (OTHER: MSD)

EV-303 ( Other Identifier ) (OTHER: Astellas Protocol Number)

PHRR210911-003890 ( Other Identifier ) (OTHER: Philippine Health Research Registry (PHRR))

jRCT2031220686 ( Registry Identifier ) (REGISTRY: Japan Registry of Clinical Trials (jRCT))

2023-504932-16 ( Registry Identifier ) (REGISTRY: EU CT)

2031220686 ( Other Identifier ) (OTHER: JRCT)

U1111-1290-4057 ( Registry Identifier ) (REGISTRY: UTN)

2018-003809-26 ( EudraCT Number )

ClinicalTrials.gov Link: https://clinicaltrials.gov/study/NCT03924895