A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract
This research study is looking into a new medicine called vepugratinib for people with bladder cancer that has either spread to other parts of the body or is too advanced to be removed. The main goal is to see if vepugratinib, when given alongside two other cancer medicines (enfortumab vedotin and pembrolizumab), is safe and effective compared to a dummy medicine (placebo). This new combination aims to help people with a specific change in their genes called an FGFR3 alteration. Taking part in this study could last up to about six years, allowing researchers to carefully monitor the effects of the treatment over time.
At a glance
What is this study about?
You've been diagnosed with bladder cancer, and you might be thinking about your treatment options. This study is for people whose bladder cancer is advanced or has spread to other parts of the body. Doctors are always looking for better ways to treat cancer, and this study aims to find out if a new medicine called vepugratinib could be helpful.
The study involves giving vepugratinib together with two other known cancer treatments, enfortumab vedotin and pembrolizumab. Some people in the study will get vepugratinib, while others will get a placebo, which looks like vepugratinib but has no active medicine. This allows doctors to fairly compare the new medicine's effects. The researchers are particularly interested in people whose cancer has a specific genetic change, known as an FGFR3 alteration, which they will check for.
By joining this study, you could help doctors learn more about this new treatment. The information gathered will help future patients with similar conditions. The study will carefully monitor your health and how the treatment affects your cancer and your body over an extended period.
Key takeaways
- This study is for advanced or spread bladder cancer with an FGFR3 gene change.
- It tests a new medicine, vepugratinib, with two other drugs.
- Some people will receive a dummy medicine (placebo) for comparison.
- Participation could last up to six years.
- Closer monitoring of your health is part of the study.
- It's about finding better treatments for the future.
Who may be eligible?
To join this study, your doctor would first need to confirm that you have bladder cancer that has either spread or is too advanced to be removed by surgery. They would also need to check if your cancer has a specific genetic change called an 'FGFR3 alteration' using a sample from your tumor or blood. You would also need to be generally well enough to take part in a study, meaning you can manage your daily activities.
There are also some important reasons why you might *not* be able to join. For example, if you've already had other treatments for your advanced or spread bladder cancer, or if you have certain unresolved side effects from previous treatments. You might also not be able to participate if you have severe nerve problems, uncontrolled cancer in your brain, or certain eye conditions like problems with your cornea or retina.
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 bladder cancer that has spread or is advanced?
- Has my doctor checked if my cancer has an FGFR3 gene change?
- Am I generally well enough to do my daily activities?
- Have I *not* received previous treatments for my advanced bladder cancer?
- Do I have any significant ongoing nerve problems?
- Have I recently had my eyes checked for specific conditions?
What does participation involve?
If you decide to join this study, you would receive either the new medicine, vepugratinib, or a placebo, in combination with enfortumab vedotin and pembrolizumab. These medicines are given at regular intervals, likely through an infusion (drip). You would have regular appointments at the hospital or clinic for these treatments, as well as for check-ups, blood tests, and scans to see how you are doing and how the treatment is affecting your cancer. These appointments will help the doctors monitor your health and any side effects. Your participation in the study could last for up to about six years, including the treatment period and follow-up to see how you are doing long-term.
Potential risks and benefits
Locations (284)
- Clearview Cancer InstituteVerified postcodeHuntsville, United States· Recruiting
- The University of Arizona Cancer Center - North CampusVerified postcodeTucson, United States· Not yet recruiting
- University of Arkansas for Medical SciencesVerified postcodeLittle Rock, United States· Not yet recruiting
- Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - IrvineVerified postcodeIrvine, United States· Not yet recruiting
- TRIO-US (Translational Research in Oncology-US)Verified postcodeLos Angeles, United States· Not yet recruiting
- UCLA Hematology/Oncology - Santa MonicaVerified postcodeLos Angeles, United States· Recruiting
- University of California, Irvine (UCI) Health - UC Irvine Medical CenterVerified postcodeOrange, United States· Not yet recruiting
- University of California Davis (UC Davis) Comprehensive Cancer CenterVerified postcodeSacramento, United States· Not yet recruiting
- UCSF Medical Center at Mission BayVerified postcodeSan Francisco, United States· Recruiting
- Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer (TMPN)Verified postcodeTorrance, United States· Recruiting
- AdventHealth Medical Group - PorterVerified postcodeDenver, United States· Not yet recruiting
- Colorado West Healthcare System - Grand Valley OncologyVerified postcodeGrand Junction, United States· Recruiting
Common questions
What is vepugratinib?
Vepugratinib is a new medicine being tested in this study to see if it can help treat advanced or spread bladder cancer, especially in people with a specific genetic change (FGFR3 alteration).
What is a placebo?
A placebo is a dummy medicine that looks just like the real medicine but contains no active drug. It helps doctors fairly compare the effects of the new medicine.
How long will I be in the study?
Your participation in the study, including treatment and follow-up, could last for up to about six years.
Are there any costs for me to be in the study?
Usually, clinical trials cover the cost of the study medicines and the appointments directly related to the research. You should discuss any potential costs for travel or other non-study related care with the study team.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason, without it affecting your future medical care.
How to find out more
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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