# Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

> **NCT04223856** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Astellas Pharma Global Development, Inc.** · enrollment: 886 (actual)

## Conditions studied

- Urothelial Cancer

## Interventions

- **DRUG:** Enfortumab vedotin
- **DRUG:** Pembrolizumab
- **DRUG:** Cisplatin
- **DRUG:** Carboplatin
- **DRUG:** Gemcitabine

## Key facts

- **NCT ID:** NCT04223856
- **Lead sponsor:** Astellas Pharma Global Development, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2020-03-30
- **Primary completion:** 2023-08-08
- **Final completion:** 2028-03-01
- **Target enrollment:** 886 (ACTUAL)
- **Last updated:** 2025-06-13

## Collaborators

- [object Object]
- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04223856

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04223856, "Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer". Retrieved via AI Analytics 2026-06-26 from https://api.ai-analytics.org/clinical/NCT04223856. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
