Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Urothelial Carcinoma, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The time from randomization to first documentation of disease progression per RECIST v1.1 by BICR, or to death due to any cause.
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 |
What the registry record for NCT05911295 still lists
NCT05911295 is an interventional study that assigns participants to a tested intervention. The registered 412 participants enrollment target is mid-sized for trials with a published cap, above the 234-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (76% higher).
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 names 20 study sites across 2 states, led by 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.
Learn More About Clinical Trials
Similar trials for Urothelial Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05911295's enrollment target sits among peer trials
412 13th of 85 higher than 73 of 85 other Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urothelial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer
RECRUITING · Phase 3
-
A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
ACTIVE NOT RECRUITING · Phase 3
-
A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
ACTIVE NOT RECRUITING · Phase 3
-
A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
ACTIVE NOT RECRUITING · Phase 3
-
Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC)
COMPLETED · Phase 3
-
Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05993689 · 412 participants · NA
Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE
- NCT06699212 · 412 participants · Phase 3
A Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab in First-line Treatment of Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck With No Distant Metastases
- NCT03592472 · 413 participants · Phase 3
A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)
- NCT06697197 · 413 participants · Phase 1
A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI