Actively Recruiting
A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)
Led by Merck Sharp & Dohme LLC · Updated on 2026-04-29
48
Participants Needed
28
Research Sites
397 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This substudy is part of an umbrella platform study which is designed to evaluate investigational agents with or without pembrolizumab in participants with urothelial carcinoma who are in need of new treatment options. Substudy 04A will enroll participants with locally advanced or mUC whose disease is resistant to treatment with programmed cell death-1/ligand 1 (PD-1/L1) inhibitors. The protocol infrastructure will enable the rolling assignment of investigational treatments.
CONDITIONS
Official Title
A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced/unresectable or metastatic urothelial carcinoma of renal pelvis, ureter, bladder, or urethra
- PD-1/L1 refractory locally advanced or metastatic urothelial carcinoma as defined by disease progression or recurrence after anti-PD-1/L1 monoclonal antibody treatment
- Provision of archival tumor tissue or new biopsy sample suitable for biomarker evaluation
- For Arm B, disease recurrence must be more than 12 months after last anti-PD-1/L1 treatment dose
You will not qualify if you...
- Known additional progressing nonurothelial malignancy requiring treatment within past 3 years
- Received systemic anticancer therapy including investigational agents within 4 weeks prior to randomization
- Active infection requiring systemic therapy
- Received live or live-attenuated vaccine within 30 days prior to first study dose
- Known history of HIV, hepatitis B, or hepatitis C infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 1045)
Orange, California, United States, 92868
Actively Recruiting
2
University of California San Francisco ( Site 1044)
San Francisco, California, United States, 94158
Actively Recruiting
3
Anschutz Cancer Pavilion ( Site 1017)
Aurora, Colorado, United States, 80045
Completed
4
University of Chicago Medical Center ( Site 1037)
Chicago, Illinois, United States, 60637
Actively Recruiting
5
Indiana University Melvin and Bren Simon Cancer Center ( Site 1011)
Indianapolis, Indiana, United States, 46202
Actively Recruiting
6
Siteman Cancer Center ( Site 1038)
St Louis, Missouri, United States, 63108
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center ( Site 1031)
New York, New York, United States, 10065
Actively Recruiting
8
Cleveland Clinic-Taussig Cancer Center ( Site 1036)
Cleveland, Ohio, United States, 44195
Actively Recruiting
9
UPMC Hillman Cancer Center ( Site 1014)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
10
Huntsman Cancer Institute ( Site 1041)
Salt Lake City, Utah, United States, 84112-5500
Actively Recruiting
11
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 1952)
Brisbane, Queensland, Australia, 4029
Completed
12
Princess Margaret Cancer Centre ( Site 1106)
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
13
FALP-UIDO ( Site 1151)
Santiago, Region M. de Santiago, Chile, 7500921
Actively Recruiting
14
Bradford Hill ( Site 1155)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
15
Rigshospitalet-Dept. of Oncology ( Site 1701)
Copenhagen, Capital Region, Denmark, 2100
Actively Recruiting
16
Rambam Health Care Campus-Oncology ( Site 1501)
Haifa, Israel, 3109601
Actively Recruiting
17
Rabin Medical Center-Oncology ( Site 1504)
Petah Tikva, Israel, 4941492
Actively Recruiting
18
Sheba Medical Center-ONCOLOGY ( Site 1503)
Ramat Gan, Israel, 5265601
Actively Recruiting
19
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1408)
Milan, Lombardy, Italy, 20133
Actively Recruiting
20
Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1406)
Naples, Italy, 80131
Actively Recruiting
21
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 1302)
Amsterdam, North Holland, Netherlands, 1066 CX
Actively Recruiting
22
Severance Hospital, Yonsei University Health System ( Site 1903)
Seoul, South Korea, 03722
Actively Recruiting
23
Asan Medical Center ( Site 1901)
Seoul, South Korea, 05505
Actively Recruiting
24
Samsung Medical Center ( Site 1902)
Seoul, South Korea, 06351
Actively Recruiting
25
Hospital Universitari Vall d'Hebron ( Site 1767)
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
26
Hospital Clinico San Carlos ( Site 1765)
Madrid, Spain, 28040
Actively Recruiting
27
St Bartholomew's Hospital ( Site 1206)
London, London, City of, United Kingdom, EC1A 7BE
Actively Recruiting
28
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 1201)
London, London, City of, United Kingdom, SW3 6JJ
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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