A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
This study is testing an investigational medicine called enfortumab vedotin. It's being given alone or in combination with another medicine called pembrolizumab to people with solid cancers that have spread to other parts of the body or can't be removed by surgery. The main goal is to see how much the tumours shrink over time with these treatments. Researchers will also look at how long people live and generally how safe and well the treatments are tolerated. Participants will be carefully monitored throughout the study with regular hospital visits and check-ups to track their health and how the treatment is working.
At a glance
Results
Results from this study
Posted April 2026Results have been published for this study.
What is this study about?
You might be reading this because you or someone you know is considering taking part in a clinical trial. This particular study is looking into a new medicine called enfortumab vedotin, which may be given on its own or alongside another medicine called pembrolizumab. It's designed for people who have solid tumours (meaning cancers that form lumps, like breast or lung cancer, rather than blood cancers) that have either spread to other parts of the body (metastatic) or are too advanced to be treated with surgery or radiation (locally advanced). The main purpose is to see how effective these treatments are at shrinking the tumours.
The researchers will be carefully measuring the size of tumours during the study to see if they get smaller. They will also be very interested in how long people live after starting the treatment, and most importantly, they will be looking closely at any side effects patients might experience. The aim of studies like this is to find better and safer ways to treat cancer, and every step in this process relies on volunteers like you.
Taking part in a study is a big decision, and it's essential to understand what it involves. Throughout the trial, doctors and nurses will monitor your health very closely. This helps them understand how the new treatment affects your body, both in terms of fighting the cancer and any potential side effects. The information gathered from this study will help healthcare professionals decide if these medicines could be helpful for more people in the future.
Key takeaways
- This study is for people with advanced solid cancers.
- It tests new medicines: enfortumab vedotin alone or with pembrolizumab.
- The main aim is to see if tumours shrink and if the treatment is safe.
- You'll have regular hospital visits, scans, and blood tests.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be able to take part in this study, you need to be an adult, as defined by local laws. You must have a solid tumour that can be measured, meaning it's big enough for doctors to track its size changes. Also, doctors will need to be able to get a sample of your tumour tissue, either from records or through a new small procedure called a biopsy.
Your general health also needs to be at a certain level. This will be checked through blood tests to make sure your organs like your kidneys and liver are working well enough, and that your blood cell counts are within a healthy range. You'll also need to be able to carry out your normal daily activities without too much difficulty. For one specific group in the study, a special test on your tumour tissue to check for something called PD-L1 might be needed. You can't take part in any other drug studies at the same time.
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.
- Are you an adult aged 18 or over?
- Do you have a solid cancer that doctors can currently measure?
- Are you generally able to perform your daily activities (ECOG 0 or 1)?
- Are your kidney, liver, and blood count test results within healthy ranges (as checked by your doctor)?
- Are you willing to provide a sample of your tumour tissue?
- Are you not currently taking part in any other medicine studies?
What does participation involve?
If you decide to join this study, it will involve three main periods: a 'screening' period, a 'treatment' period, and a 'follow-up' period. Before you start treatment, there will be check-ups for up to 28 days to make sure the study is right for you. If you qualify, you'll then begin the treatment phase.
Depending on which group you're in, you'll receive the study medicine(s) either once a week on three specific days every 28 days, or twice a week and once every 21 days for the combination treatment. These treatments will continue until your cancer gets worse, you need another cancer treatment, or you decide to stop. You'll have regular scans, typically every 6 to 8 weeks, to check on your cancer. After a year on treatment, these scans might become less frequent. Even if you stop treatment, you'll continue to have scans and be checked by the study team during the follow-up period until your cancer progresses further, you start a new cancer treatment, or other reasons.
Overall, the study will involve regular visits to the hospital for your treatment and check-ups, blood tests, and scans to monitor your health and how the treatment is working. The exact duration will depend on how you respond to treatment and other factors, but you will be closely looked after throughout.
Potential risks and benefits
Locations (39)
- Arizona OncologyVerified postcodeTucson, United States
- University of California - San FranciscoVerified postcodeSan Francisco, United States
- University of ColoradoVerified postcodeAurora, United States
- Florida Cancer SpecialistsVerified postcodeFort Myers, United States
- Florida Cancer SpecialistsVerified postcodeTallahassee, United States
- Florida Cancer SpecialistsVerified postcodeWest Palm Beach, United States
- Piedmont HospitalVerified postcodeAtlanta, United States
- Northside HospitalVerified postcodeAtlanta, United States
- Northwestern University Medical CenterVerified postcodeChicago, United States
- University of ChicagoVerified postcodeChicago, United States
- Indiana University Cancer CenterVerified postcodeIndianapolis, United States
- University of KansasVerified postcodeFairway, United States
Common questions
What is a 'solid tumour'?
A solid tumour is a mass of abnormal cells that doesn't include blood cancers like leukaemia.
What does 'locally advanced or metastatic' mean?
It means the cancer has either spread near to where it started and can't be removed with surgery, or it's spread to distant parts of the body.
What are 'enfortumab vedotin' and 'pembrolizumab'?
These are the names of the experimental medicines being tested in this study to treat cancer. They are not yet widely available for all patients.
What does 'objective response rate' mean?
It refers to whether the tumour shrinks by a certain amount after treatment, as measured by scans like CT or MRI.
Will I have to pay to be in the study?
No, you will not have to pay for the study drugs or any procedures that are part of the trial. Travel costs may be reimbursed, but you should ask the study team about this.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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