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)
This research study, called KEYMAKER-U04 Substudy 04D, is looking into new ways to treat a specific type of bladder cancer known as urothelial cancer. This cancer is considered 'locally advanced' if it has grown but can't be operated on, or 'metastatic' if it has spread to other parts of the body. The usual treatment for this condition is a combination of two medicines: enfortumab vedotin (EV) and pembrolizumab. In this study, doctors want to find out two main things. Firstly, they want to check the safety of giving a new medicine alongside the standard treatment, and if people can cope with it without too many side effects. Secondly, they want to see if this new combination helps to make the cancer smaller or disappear in more people. It's a study for people who haven't had treatment for their advanced bladder cancer before.
At a glance
What is this study about?
Imagine your body as a complex system, and sometimes, cells can grow in an uncontrolled way, leading to cancer. Urothelial cancer is a type of cancer that starts in the cells lining the bladder, and sometimes the tubes that carry urine. When this cancer has grown into nearby tissues, making it hard to remove, or if it has spread to other parts of the body, doctors call it 'locally advanced' or 'metastatic'. At this stage, doctors are constantly looking for better ways to help patients.
Currently, the standard treatment for this advanced bladder cancer involves two specific medicines: enfortumab vedotin and pembrolizumab. These medicines work in different ways to fight cancer cells. However, doctors are always trying to improve on existing treatments to give patients the best possible chance. This particular study is designed to explore if adding a new investigational medicine to this standard treatment could make it even more effective.
The main goals of this study are quite simple: first, to ensure that the new combination of treatments is safe for people to take and that any side effects are manageable. Second, and crucially, they want to see if this new treatment combination helps to shrink the cancer or even make it disappear in a larger number of patients compared to the standard treatment alone. By carefully studying these things, researchers hope to find better treatments for future patients with this type of cancer.
Key takeaways
- This study is for advanced bladder cancer (urothelial cancer) that hasn't been treated before.
- It combines a new medicine with standard treatment to see if it's safer and more effective.
- The main goals are to check treatment safety and if more people's cancer shrinks or disappears.
- You'll need a confirmed diagnosis and provide a tumor tissue sample.
- Regular hospital visits for treatment, tests, and closely monitoring your health will be part of participation.
- You can stop participating at any time if you change your mind.
Who may be eligible?
To be considered for this study, you would need to have a confirmed diagnosis of urothelial cancer that is locally advanced (meaning it has grown significantly but can't be removed with surgery) or has spread to other parts of your body. It's important that you haven't received any previous medicine-based treatment for this advanced cancer.
The research team would also need to check some recent or stored tissue samples from your tumour to understand more about your cancer. If you have conditions like HIV, Hepatitis B, or Hepatitis C, you might still be able to join if these conditions are well-managed with medication and show no active virus in your blood.
However, there are also some reasons why you might not be able to join. For example, if you have a history of serious eye problems, uncontrolled diabetes, active heart or brain conditions from the past six months, or certain autoimmune diseases that need strong medication, you likely wouldn't be able to participate. Also, if you have other cancers that are active or require treatment, or if you have certain lung or bowel conditions, you might not be suitable for this study. The study is open to both men and women, aged 18 and over.
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.
- Do I have urothelial bladder cancer that has spread or can't be removed?
- Have I had any previous drug treatments for this advanced bladder cancer?
- Do I have any serious ongoing heart, lung, or bowel conditions?
- Am I over 18 years old?
- Do I have any significant eye problems like severe dry eyes or ulcers?
- Do I have well-controlled diabetes or other medical conditions like HIV or Hepatitis B/C?
- Am I willing to provide a tissue sample from my tumour?
What does participation involve?
If you decide to take part in this study, you would receive the new investigational treatment alongside the standard medicines (enfortumab vedotin and pembrolizumab). The treatment would involve regular visits to the hospital for infusions (medicine given through a drip) and other assessments. These assessments would likely include blood tests, urine tests, physical check-ups, and scans (like CT scans).
Throughout the study, the research team would closely monitor your health and check for any side effects. You might also be given what is called 'Rescue Medication' if you experience certain side effects. The exact number of visits and the full duration of your participation would depend on how your cancer responds to the treatment and generally how you are doing, but there would be a follow-up period even after you finish the main treatment. You would be given a detailed schedule by the study team.
Potential risks and benefits
Locations (14)
- UCSF Medical Center at Mission Bay ( Site 5044)Verified postcodeSan Francisco, United States· Recruiting
- Cleveland Clinic Taussig Cancer ( Site 5036)Verified postcodeCleveland, United States· Recruiting
- Huntsman Cancer Institute ( Site 5041)Verified postcodeSalt Lake City, United States· Recruiting
- FALP ( Site 5151)Verified postcodeSantiago, Chile· Recruiting
- CHU de Bordeaux Hop St ANDRE ( Site 5607)Verified postcodeBordeaux, France· Recruiting
- Rambam Health Care Campus ( Site 5501)Verified postcodeHaifa, Israel· Recruiting
- Rabin Medical Center ( Site 5504)Verified postcodePetah Tikva, Israel· Recruiting
- Erasmus MC ( Site 5303)Verified postcodeRotterdam, Netherlands· Recruiting
- Severance Hospital, Yonsei University Health System ( Site 5903)Verified postcodeSeoul, South Korea· Recruiting
- Asan Medical Center ( Site 5901)Verified postcodeSeoul, South Korea· Recruiting
- Samsung Medical Center ( Site 5902)Verified postcodeSeoul, South Korea· Recruiting
- Hospital Universitari Vall de Hebron ( Site 5767)Verified postcodeBarcelona, Spain· Recruiting
Common questions
What is urothelial cancer?
Urothelial cancer is a type of cancer that starts in the cells lining your bladder and other parts of your urinary system.
What does 'locally advanced' or 'metastatic' mean?
Locally advanced means the cancer has grown into nearby tissues but can't be removed by surgery. Metastatic means the cancer has spread to other parts of the body.
What are enfortumab vedotin and pembrolizumab?
These are two medicines that are currently used together as a standard treatment for advanced urothelial cancer.
Will I get 'Rescue Medication'?
Rescue Medication is given if you experience certain side effects during the study to help manage them. It's there as a support if needed.
How long will I be in the study?
The length of time you'll be in the study depends on how your cancer responds and generally how you are doing. The study team will provide you with a detailed plan.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.