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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504932-16-00

Acronym

MK-3475-905

Enrollment

279

Registered

2024-02-02

Start date

2019-06-04

Completion date

Unknown

Last updated

2025-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Invasive Bladder Cancer

Brief summary

Event-Free Survival (EFS) between Arm C and Arm B

Detailed description

EFS between Arm A and Arm B, Overall Survival (OS) between Arm C and Arm B, Overall Survival (OS) between Arm A and Arm B, Pathological Complete Response (pCR) Rate between Arm C and Arm B, pCR Rate between Arm A and Arm B, Disease-Free Survival (DFS), Pathologic Downstaging (pDS) Rate between Arm A and Arm B, pDS Rate between Arm C and Arm B, Number of Participants Experiencing an Adverse Event (AE), Number of Participants Discontinuing Study Treatment due to an AE, Number of Participants Experiencing Perioperative Complications

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGENFORTUMAB VEDOTIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Event-Free Survival (EFS) between Arm C and Arm B	—

Secondary

Measure	Time frame
EFS between Arm A and Arm B, Overall Survival (OS) between Arm C and Arm B, Overall Survival (OS) between Arm A and Arm B, Pathological Complete Response (pCR) Rate between Arm C and Arm B, pCR Rate between Arm A and Arm B, Disease-Free Survival (DFS), Pathologic Downstaging (pDS) Rate between Arm A and Arm B, pDS Rate between Arm C and Arm B, Number of Participants Experiencing an Adverse Event (AE), Number of Participants Discontinuing Study Treatment due to an AE, Number of Participants Experiencing Perioperative Complications	—

Measure

Time frame

—

Countries

Belgium, Denmark, France, Germany, Hungary, Ireland, Italy, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026