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NCT04879329 · ClinicalTrials.gov registry record · Phase 2
A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2
A Phase 2 study of Urothelial Carcinoma, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 372
- Enrollment target
- 20
- Study locations
NCT04879329: Recruiting Phase 2 study of Urothelial Carcinoma, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
NCT04879329 is a Phase 2 study of Urothelial Carcinoma that is actively recruiting participants, run by Seagen, a wholly owned subsidiary of Pfizer. The registered enrollment target is 372 participants, above the 235-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (58% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04879329, a Phase 2 study of Urothelial Carcinoma, is actively recruiting participants, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 372 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.
Primary Outcome
The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1
Conditions Studied
Interventions
- DRUG pembrolizumab
- DRUG disitamab vedotin
Study Locations (20)
California
- Kaiser Permanente Anaheim Kraemer Medical Offices - Anaheim
- Foothill Cardioology - Arcadia
- Kaiser Permanente Baldwin Park Medical Center - Baldwin Park
- Kaiser Permanente Bellflower Medical Offices - Bellflower
- Beverly Hills Multi-Specialties Practice - Beverly Hills
- Providence Saint Joseph Medical Center - Burbank
- UCLA Burbank Cardiology - Burbank
- UCLA Hematology/Oncology - Burbank - Burbank
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center) - Duarte
- UCLA Encino Specialty Care (Radiology) - Encino
- UCLA Hematology/Oncoclogy-Encino - Encino
- Kaiser Permanente Fontana Medical Center - Fontana
- Foothill Cardiology Glendora - Glendora
- Kaiser Permanente South Bay Medical center - Harbor City
- Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- Kaiser Permanente Alton/Sand Canyon Medical Offices - Irvine
- UCLA Downtown Los Angeles Primary & Specialty Care - Los Angeles
- Kaiser Permanente Los Angeles Medical Offices - Los Angeles
Arizona
- Banner Gateway Medical Center - Gilbert
- Banner MD Anderson Cancer Center - Gilbert
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 372 participants |
| Start Date | 2022-05-03 |
| Est. Completion | 2029-04-14 |
| Phase | Phase 2 |
What NCT04879329 shows while recruiting
NCT04879329 is an interventional study that assigns participants to a tested intervention. The registered 372 participants enrollment target is mid-sized for trials with a published cap, above the 235-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (58% higher).
The record links to 1 condition, with Urothelial Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which pembrolizumab is the first listed.
NCT04879329 names 20 study sites across 2 states, led by California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04879329 about?
NCT04879329 is a clinical study titled "A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2". This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants. Participants will have cancer that has spread in the body near where it started (locally advanc...
What is the current status of trial NCT04879329?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 372 participants. The study started on 2022-05-03. Estimated completion is 2029-04-14.
What conditions does trial NCT04879329 study?
This clinical trial studies the following conditions: Urothelial Carcinoma.
What interventions are being tested in trial NCT04879329?
The interventions under investigation include: pembrolizumab (DRUG), disitamab vedotin (DRUG).
Who is sponsoring clinical trial NCT04879329?
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 NCT04879329 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 NCT04879329's enrollment target sits among peer trials
372 15th of 85 higher than 71 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.
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