A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations
This nationwide study is investigating a new medication called erdafitinib for people in the UK with advanced bladder cancer, specifically those whose cancer has certain genetic changes called Fibroblast Growth Factor Receptor (FGFR) aberrations. The aim is to compare erdafitinib with standard treatments like chemotherapy (vinflunine or docetaxel) or another drug called pembrolizumab. Participants will have already received one or two prior treatments for their cancer that were not fully effective. The study has two groups: one for those who have previously received a type of immunotherapy (PD-1/PD-L1 agent) and another for those who haven't. Researchers will monitor how well the treatments work, safety, and the overall experience of participants to see if erdafitinib could be a better option.
At a glance
What is this study about?
This study is designed for individuals in the UK living with advanced urothelial cancer, which is the most common type of bladder cancer. Researchers are focusing on a specific group of patients whose cancer cells have particular changes in their genes, known as Fibroblast Growth Factor Receptor (FGFR) aberrations. These genetic changes can sometimes make cancer grow, and drugs like erdafitinib are designed to target them directly.
The main goal of the study is to see if erdafitinib is more effective or safer than standard treatments currently used for advanced bladder cancer. These standard treatments include certain types of chemotherapy (vinflunine or docetaxel) or an immunotherapy drug called pembrolizumab. Participants in this study will have already tried one or two previous treatments for their cancer that haven't managed to stop its progression. The study is divided into two main groups, or 'cohorts': one for people who have already had a specific type of immunotherapy treatment, and another for those who haven't.
By comparing erdafitinib to existing treatments, the research team hopes to find a new, more effective option for people with advanced bladder cancer that has specific genetic features. This is important because it could lead to more personalised and successful treatments in the future, offering new hope to patients whose cancer has progressed after initial therapies.
Key takeaways
- This study explores a new drug (erdafitinib) for advanced bladder cancer.
- It targets specific genetic changes (FGFR aberrations) in cancer cells.
- Compares the new drug to standard treatments: chemotherapy or immunotherapy.
- For patients whose cancer has progressed after previous treatments.
- Aims to find more effective, targeted treatments for advanced bladder cancer.
- Requires regular medical check-ups and assessments.
Who may be eligible?
To be considered for this study, you must have bladder cancer that has spread or cannot be removed by surgery. Your cancer cells will need to have specific genetic changes (called FGFR aberrations). You will have already gone through treatment for your cancer, but it will have started to get worse. Depending on what treatments you've had before, you might fit into one of two groups.
There are also some general health criteria. You should be able to manage daily activities reasonably well, and your blood, liver, and kidney tests need to be within a healthy range. You'll also need to meet specific molecular requirements related to your cancer's genetic makeup. Women who could become pregnant will need to have a negative pregnancy test.
However, you won't be able to join if you're currently in another drug trial or have had certain other cancers recently. Some exceptions apply for certain types of skin or prostate cancer if they were treated a while ago and are considered cured or are under surveillance.
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 you have advanced bladder cancer that has spread or can't be surgically removed?
- Has your cancer started to get worse after recent treatments?
- Does your cancer have specific genetic changes (FGFR aberrations)?
- Are you generally well enough for daily activities (ECOG 0, 1, or 2)?
- Have you NOT been in another drug trial in the last 30 days?
- For women, are you able to provide a negative pregnancy test if you can become pregnant?
What does participation involve?
If you join this study, it will involve several stages. First, there's a screening phase to check if you're suitable. If you are, you'll enter the treatment phase, where you’ll receive either erdafitinib or one of the standard treatments (chemotherapy or pembrolizumab). The treatment phase continues until your cancer gets worse, you experience side effects that are too difficult to manage, you decide to stop, or your doctor feels it's best to discontinue.
Throughout the study, the research team will regularly assess how well the treatment is working, any side effects you might experience, and your general health. There will also be a follow-up period after your treatment ends, which will last until your death, you withdraw your consent, or the study concludes. Some participants, if they are still benefiting and the doctor agrees, may continue to receive the study drug in a long-term extension period. This study will involve regular hospital visits, blood tests, and scans.
Potential risks and benefits
Locations (345)
- Alaska Urological Institute dba Alaska Clinical Research CenterVerified postcodeAnchorage, United States
- University of Calif Davis Medical CenterVerified postcodeSacramento, United States
- St. Helena Hospital - Martin-O'Neil Cancer CenterVerified postcodeSt. Helena, United States
- MedStar Georgetown University HospitalVerified postcodeWashington D.C., United States
- University of Miami Sylvester Cancer CenterVerified postcodeMiami, United States
- Mid Florida Hematology OncologyVerified postcodeOrange, United States
- Piedmont Cancer InstituteVerified postcodeAtlanta, United States
- Rush UniversityVerified postcodeChicago, United States
- Edward Hines Jr V A HospitalVerified postcodeHines, United States
- Norton Cancer InstituteVerified postcodeLouisville, United States
- Maryland Oncology Hematology, PAVerified postcodeLanham, United States
- University of Michigan Health SystemVerified postcodeAnn Arbor, United States
Common questions
What is urothelial cancer?
Urothelial cancer is the most common type of bladder cancer. It starts in the cells that line the inside of the bladder.
What are FGFR aberrations?
These are specific genetic changes in the cancer cells that can sometimes make the cancer grow. This study is testing a drug designed to target these changes.
Will I know which treatment I'm getting?
This study involves random assignment, meaning you will be randomly assigned to receive either the new drug (erdafitinib) or one of the standard treatments. You might not know which one you are receiving initially, as this helps ensure fair comparisons.
How long will I be in the study?
The length of your participation will vary. The treatment phase continues as long as the treatment is working for you and is well-tolerated. This is followed by a long-term follow-up period.
What is 'advanced' cancer?
Advanced cancer means the cancer has spread from where it started (metastatic) or cannot be completely removed by surgery (unresectable).
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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