A Phase 1/2 Randomized, Umbrella Study to Evaluate the Efficacy and Safety of MK-2870 Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab, as Treatment for Participants With Advanced Urothelial Carcinoma (KEYMAKER-U04): Substudy 04C
This clinical trial is looking at new treatment options for adults with advanced urothelial cancer, which is cancer of the bladder or urinary tract that has spread or cannot be removed with surgery. The study tests an experimental targeted medicine named MK-2870. Doctors want to see what happens when MK-2870 is combined with another targeted cancer drug, enfortumab vedotin, either with or without an immunotherapy drug called pembrolizumab (Keytruda). These medicines are designed to seek out cancer cells directly and deliver treatment to them, or to help the body's immune system fight the cancer. The main goal of the trial is to find the safest dose of this combination, see what side effects occur, and discover how well the treatments work at shrinking tumours. Common medicines like paracetamol are also used to help prevent infusion reactions.
At a glance
What is this study about?
Urothelial cancer is the most common type of bladder cancer. It can also develop in other parts of the urinary tract, including the tubes connecting the kidneys to the bladder. When this cancer is 'advanced', it means it has grown into nearby tissues or spread to other parts of the body. Advanced bladder cancer can be difficult to treat, especially when standard options are no longer working well, so doctors are looking for newer, more effective approaches.
This study evaluates a new drug called MK-2870. MK-2870 and enfortumab vedotin belong to a group of treatments called antibody-drug conjugates. You can think of these as guided missiles: they latch onto specific markers on the outside of cancer cells and deliver a powerful cancer-killing medicine directly inside them, which helps limit harm to healthy cells. Some patients in the study also receive pembrolizumab, an immunotherapy that helps the body's own immune system recognise and attack cancer cells.
The trial is split into two phases. The first phase focuses on safety, helping researchers find the right dose and watch closely for side effects. The second phase looks at how well the combination shrinks tumours and how long the benefits last. By testing these medicines together, researchers hope to provide a stronger, more targeted treatment option for people facing advanced urinary cancers.
Key takeaways
- Tests a new combination of targeted drugs (MK-2870 and enfortumab vedotin) with or without immunotherapy.
- Aimed at adults with advanced or spread bladder and urinary tract cancer.
- The study focuses on finding the safest doses and measuring how well tumours respond.
- All medicines are given as drips into a vein during hospital clinic visits.
- Participation is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This study is open to men and women aged 18 and over who have advanced or metastatic urothelial cancer. This means the cancer has spread beyond the bladder or urinary tract, or cannot be safely removed with surgery.
To take part, you generally need to be well enough to carry out everyday activities, and your major organs, such as your liver, kidneys, and bone marrow, must be working well enough to handle cancer treatment. Doctors will run blood and scan tests to confirm this.
You might not be able to join if you have certain other active medical conditions, severe infections, or if you have previously had specific treatments that make this combination unsafe for you. The trial team will carefully check your full medical history before deciding if the study is suitable.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with advanced or metastatic urothelial (bladder or urinary tract) cancer.
- My cancer cannot be completely removed with surgery.
- I am well enough to attend regular hospital appointments for treatment and tests.
- I am open to receiving cancer medicines by a drip in a hospital clinic.
What does participation involve?
Taking part in this study involves regular visits to a specialist hospital clinic. The study medicines are given as a drip into a vein (an intravenous infusion) on set days across treatment cycles that typically last a few weeks each. Before your infusions, you may receive everyday medicines like paracetamol and dexamethasone to lower the chance of mild allergic reactions or side effects.
During your visits, you will have routine health checks, including blood tests, physical examinations, and questions about how you are feeling. You will also have regular CT or MRI scans to monitor your tumours. Treatment usually continues for as long as the cancer does not worsen and any side effects remain manageable. After you stop treatment, the study team will stay in touch for regular follow-up checks to monitor your health.
Potential risks and benefits
Locations (5)
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedDenmark
- —UnverifiedNetherlands
- —UnverifiedItaly
Common questions
What is an antibody-drug conjugate?
It is a targeted cancer medicine made of an antibody joined to a chemotherapy drug. The antibody finds cancer cells, and the drug destroys them from the inside.
Will I receive a dummy treatment (placebo)?
No, all participants in this study receive active cancer treatments. There is no placebo-only group.
How often will I need to visit the hospital?
You will need to visit the hospital several times a month for treatment infusions, blood tests, and health reviews, especially in the early stages.
Can I leave the study if I change my mind?
Yes. You have the right to withdraw from the trial at any point, and your regular medical team will continue to care for you.
Why am I given paracetamol before treatment?
Medicines like paracetamol help prevent common infusion reactions, such as fever, chills, or headaches, during or after your drip.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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