Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2
Public ClinicalTrials.gov record NCT05911295. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05911295
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 412 participants
Conditions and interventions
Conditions
Interventions
- disitamab vedotin Drug
- pembrolizumab Drug
- gemcitabine Drug
- cisplatin Drug
- carboplatin Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 21, 2023
- Primary completion
- Jan 28, 2027
- Completion
- Apr 29, 2029
- Last update posted
- Jul 21, 2026
2023 – 2029
United States locations
- U.S. sites
- 89
- U.S. states
- 6
- U.S. cities
- 49
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner Gateway Medical Center | Gilbert | Arizona | 85234 | — |
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | — |
| UCLA Hematology/Oncology - Alhambra | Alhambra | California | 91801 | — |
| Foothill Cardioology | Arcadia | California | 91007 | — |
| Beverly Hills Multi-Specialties Practice | Beverly Hills | California | 90211 | — |
| Providence Saint Joseph Medical Center | Burbank | California | 91505 | — |
| UCLA Burbank Cardiology | Burbank | California | 91505 | — |
| UCLA Hematology/Oncology - Burbank | Burbank | California | 91505 | — |
| UCLA Calabasas Specialty Care | Calabasas | California | 91302 | — |
| UCLA Encino Specialty Care (Radiology) | Encino | California | 91436 | — |
| UCLA Hematology/Oncology - Encino | Encino | California | 91436 | — |
| Helios Clinical Research | Fountain Valley | California | 92708 | — |
| Helios Clinical Research | Glendale | California | 91204 | — |
| Foothill Cardiology Glendora | Glendora | California | 91741 | — |
| Helios Clinical Research | Long Beach | California | 90805 | — |
| UCLA Downtown Los Angeles Primary & Specialty Care | Los Angeles | California | 90017 | — |
| UCLA Cardiovascular Center | Los Angeles | California | 90095 | — |
| UCLA Department of Medicine-Hematology/Oncology | Los Angeles | California | 90095 | — |
| UCLA Hematology & Oncology Clinic | Los Angeles | California | 90095 | — |
| UCLA Hematology / Oncology | Los Angeles | California | 90095 | — |
| UCLA Westwood Specialty Care | Los Angeles | California | 90095 | — |
| UCLA Montecito Primary & Specialty Care | Montecito | California | 93108 | — |
| Pacific Cancer Care | Monterey | California | 93940 | — |
| Newport Diagnostics | Newport Beach | California | 92660 | — |
| Foothill Cardiology Pasadena | Pasadena | California | 91105 | — |
| Southern California Heart Specialists | Pasadena | California | 91105 | — |
| UCLA Porter Ranch Primary & Specialty Care | Porter Ranch | California | 91326 | — |
| UCSF Center at China Basin Imaging | San Francisco | California | 94107 | — |
| Helen Diller Family Comprehensive Cancer Center - Imaging Post | San Francisco | California | 94115 | — |
| UCSF Cancer Center MZ Phlebotomy | San Francisco | California | 94115 | — |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | — |
| UCSF Mount Zion Phlebotomy | San Francisco | California | 94115 | — |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94143 | — |
| UCSF Parnassus Phlebotomy | San Francisco | California | 94143 | — |
| UCSF Parnassus-5 Lab | San Francisco | California | 94143 | — |
| Cardiovascular Care and Prevention Center at Mission Bay | San Francisco | California | 94158 | — |
| UCSF Investigational Drugs Pharmacy | San Francisco | California | 94158 | — |
| UCSF Mission Bay Gateway-2 Lab | San Francisco | California | 94158 | — |
| UCSF Mission Bay PCMB-5 Lab | San Francisco | California | 94158 | — |
| UCSF Mission Bay Pediatric Clinical Research Center | San Francisco | California | 94158 | — |
| UCSF Mission Bay Radiology and Nuclear Medicine | San Francisco | California | 94158 | — |
| University of California San Francisco | San Francisco | California | 94158 | — |
| University of California, San Francisco | HDFCCC - Hematopoietic malignancies | San Francisco | California | 94158 | — |
| The Regents of the University of California | San Francisco | California | 94160 | — |
| Diagnostic Medical Group of Southern California, , San Gabriel, CA | San Gabriel | California | 91776 | — |
| Southern California Heart Centers | San Gabriel | California | 91776 | — |
| UCLA Hematology/Oncology - San Luis Obispo | San Luis Obispo | California | 93401 | — |
| Sierra Vista Regional Medical Center | San Luis Obispo | California | 93405 | — |
| Helios Clinical Research | Santa Ana | California | 92705 | — |
| UCLA Hematology/Oncology - Santa Barbara | Santa Barbara | California | 93105 | — |
| UCLA Santa Monica Cardiology | Santa Monica | California | 90404 | — |
| UCLA Simi Valley Alamo Specialty Care | Simi Valley | California | 93065 | — |
| Twin Cities Community Hospital | Templeton | California | 93455 | — |
| UCLA Thousand Oaks Primary & Specialty Care | Thousand Oaks | California | 91360 | — |
| UCLA Hematology/Oncology - Torrance | Torrance | California | 90505 | — |
| UCLA Torrance Lomita Specialty Care | Torrance | California | 90505 | — |
| UCLA Santa Clarita Primary & Specialty Care | Valencia | California | 91355 | — |
| UCLA Ventura Cardiology | Ventura | California | 93003 | — |
| UCLA Hematology/Oncology - Westlake | Westlake Village | California | 91361 | — |
| Helios Clinical Research | Whittier | California | 90602 | — |
| HealthPartners Institute | Bloomington | Minnesota | 55425 | — |
| Minnesota Oncology Hematology, PA | Burnsville | Minnesota | 55337 | — |
| Allina Health Cancer Institute | Coon Rapids | Minnesota | 55433 | — |
| Minnesota Oncology Hematology, PA | Coon Rapids | Minnesota | 55433 | — |
| M Health Fairview Cancer Clinic-Edina | Edina | Minnesota | 55435 | — |
| Minnesota Oncology Hematology Pa | Edina | Minnesota | 55435 | — |
| Minnesota Oncology Hematology, PA | Fridley | Minnesota | 55432 | — |
| M Health Fairview St. John's Hospital | Maplewood | Minnesota | 55109 | — |
| Minnesota Oncology Hematology, PA | Maplewood | Minnesota | 55109 | — |
| Allina Health Cancer Institute-United(VPCI) | Minneapolis | Minnesota | 55404 | — |
| Minnesota Oncology Hematology, PA | Minneapolis | Minnesota | 55404 | — |
| Hennepin Country Medical Center | Minneapolis | Minnesota | 55415 | — |
| North Memorial Health Cancer Center | Robbinsdale | Minnesota | 55422 | — |
| Metro Minnesota Community Oncology Research Consortium(MMCORC) | Saint Louis Park | Minnesota | 55426 | — |
| Park Nicollet Frauenshuh Cancer Center | Saint Louis Park | Minnesota | 55426 | — |
| Regions Hospital | Saint Paul | Minnesota | 55101 | — |
| Allina Health Cancer Institute-United(VPCI) | Saint Paul | Minnesota | 55102 | — |
| Minnesota Oncology Hematology, PA | Woodbury | Minnesota | 55125 | — |
| AHN Saint Vincent Hospital | Erie | Pennsylvania | 16544 | — |
| AHN Jefferson Hospital | Jefferson Hills | Pennsylvania | 15025 | — |
| AHN Forbes Hospital | Monroeville | Pennsylvania | 15146 | — |
| Allegheny Valley Hospital | Natrona Heights | Pennsylvania | 15065 | — |
| AHN Cancer Institute - Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| AHN Cancer Institute Pharmacy | Pittsburgh | Pennsylvania | 15212 | — |
| AHN West Penn Hospital | Pittsburgh | Pennsylvania | 15224 | — |
| Helios Clinical Research | Fort Worth | Texas | 76104 | — |
| Harborview Medical Center | Seattle | Washington | 98104 | — |
| Fred Hutchinson Cancer Center. | Seattle | Washington | 98109 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 179 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05911295, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 21, 2026 · Synced Sep 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05911295 live on ClinicalTrials.gov.