NCT05911295

Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2

An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination With Pembrolizumab Versus Chemotherapy in Subjects With Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma That Expresses HER2 (IHC 1+ and Greater)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 412 (actual)
• Sponsor: Seagen, a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will enroll participants with urothelial cancer (UC). UC can include cancer of the bladder, kidney, or the tubes that carry pee through the body (ureter, urethra). This study will try to find out if the drugs disitamab vedotin with pembrolizumab works better than platinum-containing chemotherapy to treat patients with UC. This study will also test what side effects happen when participants take these drugs together. A side effect is anything a drug does to the body besides treating the disease. Participants in this study will have cancer that has spread through the body (metastatic) or spread near where it started (locally advanced). In this study, there are 2 different groups. Participants will be assigned to a group randomly. Participants in the disitamab vedotin arm will get the study drug disitamab vedotin once every two weeks and pembrolizumab once every 6 weeks. Participants in the standard of care arm will get gemcitabine once a week for 2 weeks with either cisplatin or carboplatin once every 3 weeks.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	disitamab vedotin	Given into the vein (IV; intravenous) every 2 weeks
DRUG	pembrolizumab	400mg given by IV every 6 weeks
DRUG	gemcitabine	1000 mg/m\^2 given by IV on days 1 and 8 of every 3-week cycle
DRUG	cisplatin	70 mg\^2 given by IV on day 1 of every 3-week cycle
DRUG	carboplatin	Area under the plasma concentration-time curve (AUC) 4.5 or 5 given by IV on day 1 of every 3-week cycle

Timeline

• Start date: 2023-09-22
• Primary completion: 2026-06-30
• Completion: 2029-04-30
• First posted: 2023-06-22
• Last updated: 2026-04-07

Locations

279 sites across 24 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Czechia, France, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Peru, Portugal, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study