NCT04879329

A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2

A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone or in Combination With Pembrolizumab in Subjects With Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 372 (estimated)
• Sponsor: Seagen, a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	disitamab vedotin	Given into the vein (IV; intravenous) every 2 weeks.
DRUG	pembrolizumab	Given by IV on Day 1 of each 6-week cycle.

Timeline

• Start date: 2022-05-03
• Primary completion: 2026-12-11
• Completion: 2029-04-14
• First posted: 2021-05-10
• Last updated: 2026-01-07

Locations

221 sites across 12 countries: United States, Argentina, Australia, Belgium, Canada, Chile, Israel, Italy, Japan, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study