Clinical Trials in the UK / NCT07232602
Recruiting
Phase 1/2
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)
NCT07232602 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Bladder Cancer
Investigational drug(s) / intervention(s)
MK-3120: Administered via intravenous (IV) infusion on day 1 and day 8 of each 3-week cycle
EV: Administered via IV infusion on day 1 and day 8 of each 3-week cycle
Pembrolizumab: Administered via IV infusion on day 1 of each 3-week cycle
Rescue Medication: Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).
Study summary
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.
Eligibility
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has histologically documented urothelial carcinoma (UC) that is locally advanced and unresectable or metastatic
* Must provide a newly obtained or archival tumor tissue sample (core or excisional biopsy)
* Must not have received prior systemic therapy for locally advanced or metastatic UC
* If infected with Human Immunodeficiency Virus (HIV), has well controlled HIV on antiretroviral therapy
* If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load before randomization
* If participant has a history of hepatitis C virus (HCV), has undetectable HCV viral load before randomization
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
* Has active keratitis or corneal ulcerations
* Has active inflammatory bowel disease requiring immunosuppressive medication, or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention
* Has a history of uncontrolled diabetes
* Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage
* Has active autoimmune disease that has required systemic treatment in the past 2 years
* Has known additional malignancy that is progressing or has required active treatment within the past 2 years
* Has known active central nervous system metastases and/or carcinomatous meningitis
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids, or has current pneumonitis/interstitial lung disease
* Has an active infection requiring systemic therapy
* If infected with HIV, has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has concurrent active HBV and HCV infection
* Has a history of stem cell/solid organ transplant
Primary outcome measure(s)
- Number of Participants Who Experience an Adverse Event (AE) — Up to approximately 27 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experience AEs will be reported. - Number of Participants Who Experience a Dose Limiting Toxicity (DLT) — Up to approximately 21 days
DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next treatment. The number of participants who experience a DLT as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 will be presented. - Number of Participants Who Discontinue Study Treatment Due to an AE — Up to approximately 24 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinue study intervention due to an AE will be reported. - Objective Response Rate (ORR) as Assessed by Investigator — Up to approximately 58 months
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Investigator will be presented.
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| UCSF Medical Center at Mission Bay ( Site 5044) | San Francisco | California | Recruiting |
| University of Chicago Medical Center ( Site 5037) | Chicago | Illinois | Recruiting |
| Memorial Sloan Kettering Cancer Center ( Site 5031) | New York | New York | Recruiting |
| Cleveland Clinic Taussig Cancer ( Site 5036) | Cleveland | Ohio | Recruiting |
| Huntsman Cancer Institute ( Site 5041) | Salt Lake City | Utah | Recruiting |
| Fundación Arturo López Pérez ( Site 5151) | Santiago | Region M. de Santiago | Recruiting |
| CHU de Bordeaux Hop St ANDRE ( Site 5607) | Bordeaux | Gironde | Recruiting |
| Rambam Health Care Campus ( Site 5501) | Haifa | Israel | Recruiting |
| Rabin Medical Center ( Site 5504) | Petah Tikva | Israel | Recruiting |
| Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 5302) | Amsterdam | North Holland | Recruiting |
| Erasmus MC ( Site 5303) | Rotterdam | South Holland | Recruiting |
| Severance Hospital, Yonsei University Health System ( Site 5903) | Seoul | South Korea | Recruiting |
| Asan Medical Center ( Site 5901) | Seoul | South Korea | Recruiting |
| Samsung Medical Center ( Site 5902) | Seoul | South Korea | Recruiting |
| Hospital Universitari Vall de Hebron ( Site 5767) | Barcelona | Spain | Recruiting |
| Hospital Clinico San Carlos ( Site 5765) | Madrid | Spain | Recruiting |
| St Bartholomew s Hospital ( Site 5206) | London | London, City of | Recruiting |
On this site
📄 Keytruda (pembrolizumab) drug profile →More Merck Sharp & Dohme LLC trials in the UK
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07232602 on ClinicalTrials.gov ↗ ← All trials in the UK