Actively Recruiting
KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04)
Led by Merck Sharp & Dohme LLC · Updated on 2026-04-24
55
Participants Needed
14
Research Sites
282 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are looking for new ways to treat people with urothelial cancer (UC) that is locally advanced or metastatic. The standard treatment for locally advanced or metastatic UC is enfortumab vedotin (EV) given with pembrolizumab. The goals of this study are to learn about: * The safety of the study treatment when given with standard treatment and if people tolerate it * The number of people who have the cancer respond (cancer gets smaller or goes away) with the new study treatment when given with standard treatment.
CONDITIONS
Official Title
KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed urothelial carcinoma that is locally advanced, unresectable, or metastatic
- Provides a new or archived tumor tissue sample from core or excisional biopsy
- Has not received prior systemic therapy for locally advanced or metastatic urothelial carcinoma
- If infected with HIV, HIV is well controlled with antiretroviral therapy
- If positive for hepatitis B surface antigen, has been on antiviral therapy for at least 4 weeks with undetectable viral load before randomization
- If has history of hepatitis C virus infection, has undetectable viral load before randomization
You will not qualify if you...
- History of severe dry eye syndrome, severe Meibomian gland disease, blepharitis, or corneal disease delaying healing
- Active keratitis or corneal ulcers
- Active inflammatory bowel disease requiring immunosuppressive medication or previous history of such diseases
- Uncontrolled significant cardiovascular or cerebrovascular disease within 6 months before study
- History of uncontrolled diabetes
- Symptomatic pleural effusion, ascites, or pericardial effusion requiring repeated drainage
- Active autoimmune disease treated systemically within past 2 years
- Additional progressing malignancy or requiring active treatment within past 2 years
- Active central nervous system metastases or carcinomatous meningitis
- History of or current noninfectious pneumonitis or interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- HIV infection with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Concurrent active hepatitis B and C infections
- History of stem cell or solid organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
UCSF Medical Center at Mission Bay ( Site 5044)
San Francisco, California, United States, 94158
Actively Recruiting
2
Cleveland Clinic Taussig Cancer ( Site 5036)
Cleveland, Ohio, United States, 44195
Actively Recruiting
3
Huntsman Cancer Institute ( Site 5041)
Salt Lake City, Utah, United States, 84112-5550
Actively Recruiting
4
FALP ( Site 5151)
Santiago, Region M. de Santiago, Chile, 7500921
Actively Recruiting
5
CHU de Bordeaux Hop St ANDRE ( Site 5607)
Bordeaux, Gironde, France, 33075
Actively Recruiting
6
Rambam Health Care Campus ( Site 5501)
Haifa, Israel, 3109601
Actively Recruiting
7
Rabin Medical Center ( Site 5504)
Petah Tikva, Israel, 4941492
Actively Recruiting
8
Erasmus MC ( Site 5303)
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
9
Severance Hospital, Yonsei University Health System ( Site 5903)
Seoul, South Korea, 03722
Actively Recruiting
10
Asan Medical Center ( Site 5901)
Seoul, South Korea, 05505
Actively Recruiting
11
Samsung Medical Center ( Site 5902)
Seoul, South Korea, 06351
Actively Recruiting
12
Hospital Universitari Vall de Hebron ( Site 5767)
Barcelona, Spain, 08035
Actively Recruiting
13
Hospital Clinico San Carlos ( Site 5765)
Madrid, Spain, 28040
Actively Recruiting
14
St Bartholomew s Hospital ( Site 5206)
London, London, City of, United Kingdom, EC1A 7BE
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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