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Study identifier: NCT05911295 Synced from ClinicalTrials.gov · August 04, 2026
● Active Not Recruiting

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

Condition: Urothelial Carcinoma  ·  Sponsor: Seagen, a wholly owned subsidiary of Pfizer

PhasePhase 3
Planned participants412
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Locations (268)

Banner Gateway Medical CenterGilbert, Arizona, United States
Banner MD Anderson Cancer CenterGilbert, Arizona, United States
UCLA Hematology/Oncology - AlhambraAlhambra, California, United States
Foothill CardioologyArcadia, California, United States
Beverly Hills Multi-Specialties PracticeBeverly Hills, California, United States
Providence Saint Joseph Medical CenterBurbank, California, United States
UCLA Burbank CardiologyBurbank, California, United States
UCLA Hematology/Oncology - BurbankBurbank, California, United States
UCLA Calabasas Specialty CareCalabasas, California, United States
UCLA Encino Specialty Care (Radiology)Encino, California, United States
UCLA Hematology/Oncology - EncinoEncino, California, United States
Helios Clinical ResearchFountain Valley, California, United States

+ 256 more locations — full list on the registry record.

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