# 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)

> **NCT03924895** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Merck Sharp & Dohme LLC** · enrollment: 595 (actual)

## Conditions studied

- Urinary Bladder Cancer, Muscle-invasive

## Interventions

- **DRUG:** Pembrolizumab
- **PROCEDURE:** Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
- **DRUG:** Enfortumab Vedotin

## Key facts

- **NCT ID:** NCT03924895
- **Lead sponsor:** Merck Sharp & Dohme LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2019-07-24
- **Primary completion:** 2025-06-06
- **Final completion:** 2027-12-15
- **Target enrollment:** 595 (ACTUAL)
- **Last updated:** 2025-08-28

## Collaborators

- [object Object]
- [object Object]

## Primary source

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

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03924895, "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)". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT03924895. Licensed CC0.

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