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

NCT04223856 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 886

Last updated 2025-06-13

Study results available
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Summary

This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.

Conditions

Interventions

DRUG

Enfortumab vedotin

Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle

DRUG

Pembrolizumab

IV infusion on Day 1 of every 3-week cycle

DRUG

Cisplatin

administered as IV infusion on Day 1 of each 3-week cycle

DRUG

Carboplatin

Dosed according to local guidelines and will be administered as IV infusion on Day 1 of each 3-week cycle

DRUG

Gemcitabine

IV infusion on Days 1 and 8 of every 3 week cycle

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Seagen Inc.

    collaborator INDUSTRY

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Zejing Wang, MD, PhD · Seagen Inc.

  • John Lu, MD · Seagen Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-30
Primary Completion
2023-08-08
Completion
2028-03-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • China
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04223856 on ClinicalTrials.gov