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NCT05911295 · ClinicalTrials.gov registry record · Phase 3
Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2
A Phase 3 study of Urothelial Carcinoma, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- Active
- Registry status
- Phase 3
- Development phase
- 412
- Enrollment target
- 20
- Study locations
NCT05911295 is a Phase 3 study of Urothelial Carcinoma that is active but no longer recruiting, run by Seagen, a wholly owned subsidiary of Pfizer. The registered enrollment target is 412 participants, above the 234-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (76% higher). The trial reports 20 study locations across 2 states.
The verdict
NCT05911295, a Phase 3 study of Urothelial Carcinoma, is active but no longer recruiting, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 412 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG pembrolizumab
- DRUG disitamab vedotin
- DRUG cisplatin
- DRUG carboplatin
- DRUG gemcitabine
Study Locations (20)
California
- UCLA Hematology/Oncology - Alhambra - Alhambra
- Foothill Cardioology - Arcadia
- Beverly Hills Multi-Specialties Practice - Beverly Hills
- Providence Saint Joseph Medical Center - Burbank
- UCLA Burbank Cardiology - Burbank
- UCLA Hematology/Oncology - Burbank - Burbank
- UCLA Calabasas Specialty Care - Calabasas
- UCLA Encino Specialty Care (Radiology) - Encino
- UCLA Hematology/Oncology - Encino - Encino
- Helios Clinical Research - Fountain Valley
- Helios Clinical Research - Glendale
- Foothill Cardiology Glendora - Glendora
- Helios Clinical Research - Long Beach
- UCLA Downtown Los Angeles Primary & Specialty Care - Los Angeles
- UCLA Cardiovascular Center - Los Angeles
- UCLA Department of Medicine-Hematology/Oncology - Los Angeles
- UCLA Hematology & Oncology Clinic - Los Angeles
- UCLA Hematology / Oncology - Los Angeles
Arizona
- Banner Gateway Medical Center - Gilbert
- Banner MD Anderson Cancer Center - Gilbert
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 412 participants |
| Start Date | 2023-09-22 |
| Est. Completion | 2029-04-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05911295
The ClinicalTrials.gov registry entry for NCT05911295 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 412 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 234-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (76% higher). The listed sponsor is Seagen, a wholly owned subsidiary of Pfizer, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which pembrolizumab is the first listed.
NCT05911295 reports 20 study locations spanning 2 distinct geographic areas - top geographies include California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05911295 about?
NCT05911295 is a clinical study titled "Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2". 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 chemo...
What is the current status of trial NCT05911295?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 412 participants. The study started on 2023-09-22. Estimated completion is 2029-04-30.
What conditions does trial NCT05911295 study?
This clinical trial studies the following conditions: Urothelial Carcinoma.
What interventions are being tested in trial NCT05911295?
The interventions under investigation include: pembrolizumab (DRUG), disitamab vedotin (DRUG), cisplatin (DRUG), carboplatin (DRUG), gemcitabine (DRUG).
Who is sponsoring clinical trial NCT05911295?
This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05911295 being conducted?
This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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