At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- MK-3120 (drug), EV (drug), Pembrolizumab (biological), Rescue Medication (drug)
- How long the study runs
- Study runs about 65 months (dates as stated)
- About the drug or intervention
- MK-3120 — drug: Administered via intravenous (IV) infusion on day 1 and day 8 of each 3-week cycle · EV — drug: Administered via IV infusion on day 1 and day 8 of each 3-week cycle · Pembrolizumab — biological: Administered via IV infusion on day 1 of each 3-week cycle · Rescue Medication — drug: Participants receive rescue medication at the investigator's discretion, per approved product label.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 55
- Started
- 2026-02-09
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for bladder cancer
- • Phase1/Phase2 - 55 participants
- • Researchers are looking for new ways to treat people with urothelial cancer (UC) that is locally advanced or metastatic
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with bladder cancer
Where?
- • London - St Bartholomew s Hospital ( Site 5206)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
This is a substudy of the master protocol MK-3475-U04 (KEYMAKER-U04)
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓The main inclusion criteria include but are not limited to the following:
- ✓Has histologically documented urothelial carcinoma (UC) that is that has grown locally and unresectable or that has spread
- ✓Must provide a newly obtained or archival tumor tissue sample (core or excisional biopsy)
- ✓Must not have received prior treatment that goes through your whole body for that has grown locally or that has spread UC
- ✓If infected with Human Immunodeficiency Virus (HIV), has well controlled HIV on antiretroviral therapy
Who cannot take part
- ✗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...
- ✗Has active keratitis or corneal ulcerations
- ✗Has active inflammatory bowel disease requiring immunosuppressive medication, or previous history of inflammatory...
- ✗Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study...
See the full criteria
Where Is This Study? (1 UK site)
St Bartholomew s Hospital ( Site 5206)
London EC1A 7BE, United Kingdom
How to Get in Touch
Toll Free Number
Sponsor contactCONTACT
