Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2 (NCT05911295)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Banner Gateway Medical Center — Gilbert, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (268 Sites)
Showing the first 25 of 268 sites.
- Banner Gateway Medical Center — Gilbert, Arizona
- Banner MD Anderson Cancer Center — Gilbert, Arizona
- UCLA Hematology/Oncology - Alhambra — Alhambra, California
- Foothill Cardioology — Arcadia, California
- Beverly Hills Multi-Specialties Practice — Beverly Hills, California
- Providence Saint Joseph Medical Center — Burbank, California
- UCLA Burbank Cardiology — Burbank, California
- UCLA Hematology/Oncology - Burbank — Burbank, California
- UCLA Calabasas Specialty Care — Calabasas, California
- UCLA Encino Specialty Care (Radiology) — Encino, California
- UCLA Hematology/Oncology - Encino — Encino, California
- Helios Clinical Research — Fountain Valley, California
- Helios Clinical Research — Glendale, California
- Foothill Cardiology Glendora — Glendora, California
- Helios Clinical Research — Long Beach, California
- UCLA Downtown Los Angeles Primary & Specialty Care — Los Angeles, California
- UCLA Cardiovascular Center — Los Angeles, California
- UCLA Department of Medicine-Hematology/Oncology — Los Angeles, California
- UCLA Hematology & Oncology Clinic — Los Angeles, California
- UCLA Hematology / Oncology — Los Angeles, California
- UCLA Westwood Specialty Care — Los Angeles, California
- UCLA Montecito Primary & Specialty Care — Montecito, California
- Pacific Cancer Care — Monterey, California
- Newport Diagnostics — Newport Beach, California
- Foothill Cardiology Pasadena — Pasadena, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Urothelial Carcinoma
- Study to Evaluate Adverse Events and Change in Disease Activity When Intravenously (IV) Infused Livmoniplimab is Used in Combination With IV Infused Budigalimab in Adult Participants With Urothelial Carcinoma (UC) — Springdale, Arkansas
- Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma — Philadelphia, Pennsylvania
- A Phase 2 Study to Evaluate the Triplet Combination of Pemetrexed Plus AB928 (Etrumadenant) + AB122 (Zimberelimab) in Patients With Previously Treated Advanced or Metastatic MTAP Deficient Urothelial Carcinoma — Houston, Texas
- A Phase II Multicenter Study of Chemotherapy Versus Chemotherapy Plus Durvalumab (MEDI 4736) in Patients With Lymph Node Positive Urothelial Carcinoma of the Bladder — Bloomington, Indiana
- Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma — Oklahoma City, Oklahoma
- Intravesical Adoptive Cell Therapy w/ TIL for BCG Exposed High Grade NMIBC — Tampa, Florida
Explore by condition: All Urothelial Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.