A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions
This study is looking at a type of bladder cancer called non-muscle-invasive bladder cancer, specifically when it has certain genetic changes (called FGFR mutations or fusions) and has returned after initial treatment with BCG. We want to find a better way to stop the cancer from coming back. The study compares a new drug called erdafitinib with standard bladder treatments chosen by the doctor, like gemcitabine or mitomycin. The main goal is to see if erdafitinib can keep the cancer away for longer. It's a 'Phase 2' study, meaning we're exploring how well the new treatment works and its safety in a larger group of patients.
At a glance
What is this study about?
This study is for adults who have been diagnosed with a type of bladder cancer called non-muscle-invasive bladder cancer (NMIBC). This means the cancer is in the lining of the bladder but hasn't spread deeper into the bladder muscle. Specifically, the study is for people whose cancer has a particular genetic change, known as an FGFR mutation or fusion. This change can sometimes make the cancer harder to treat or more likely to come back.
You might be eligible for this study if your NMIBC has returned after you've already had a standard treatment called Bacillus Calmette-Guérin (BCG). BCG is a common treatment, but sometimes the cancer comes back despite this. The purpose of this study is to explore if a new medicine, erdafitinib, can be more effective than other treatments at stopping the cancer from returning.
The study will compare erdafitinib with other treatments that doctors usually choose in these situations, such as gemcitabine or mitomycin. We want to find out which treatment is better at keeping the bladder cancer away for longer periods. By taking part, you would be helping doctors understand how to best treat this type of bladder cancer in the future.
Key takeaways
- This study is for non-muscle-invasive bladder cancer that has returned.
- It focuses on cancer with specific genetic changes (FGFR mutations/fusions).
- It compares a new drug (erdafitinib) with standard bladder treatments.
- The main aim is to see if the new drug can stop cancer from returning for longer.
- Participation involves regular clinic visits and close monitoring.
- You can choose to leave the study at any time.
Who may be eligible?
This study is open to adults aged 18 or older, no matter their sex. You might be able to join if you have non-muscle-invasive bladder cancer (NMIBC) that has certain genetic changes called FGFR mutations or fusions.
Critically, your bladder cancer must have come back even after you've had a standard treatment called BCG. The study has different groups depending on how risky your cancer is considered – either high-risk or intermediate-risk NMIBC.
Your study doctor will carefully check your medical history, your specific type of bladder cancer, and the results of certain tests to make sure this study is right for you. They will explain all the requirements in detail.
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 18 years old or older?
- Have you been diagnosed with non-muscle-invasive bladder cancer (NMIBC)?
- Has your cancer returned after you've had BCG treatment?
- Does your bladder cancer have specific genetic changes called FGFR mutations or fusions?
- Are you able to attend regular clinic appointments for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, you would first go through a screening period where doctors run tests to make sure you're eligible. If you are, you'll be put into one of the treatment groups – either receiving the new drug erdafitinib or one of the standard bladder treatments (like gemcitabine or mitomycin), chosen by your doctor. The study will involve regular visits to the clinic for check-ups, tests, and to receive your treatment.
These visits will include physical exams, blood and urine tests, and checks to see how you are responding to the treatment and if you are experiencing any side effects. The exact schedule of visits and tests will depend on which treatment group you are in. You will be closely monitored throughout the study period, which will involve regular follow-up after your main treatment phase to see if the cancer stays away.
Potential risks and benefits
Locations (3)
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedPoland
Common questions
What is 'non-muscle-invasive bladder cancer'?
This is a type of bladder cancer that has only grown into the inner lining of your bladder and has not spread into the deeper muscle wall.
What does 'FGFR mutations or fusions' mean?
These are specific changes in the genes of your cancer cells. These changes can sometimes make the cancer behave differently and can be targeted by certain treatments.
What is BCG treatment?
BCG (Bacillus Calmette-Guérin) is a common treatment for non-muscle-invasive bladder cancer where a liquid containing a weakened bacteria is put directly into your bladder.
What is erdafitinib?
Erdafitinib is a new drug being tested in this study. It's designed to target cancer cells that have the specific FGFR genetic changes mentioned earlier.
Will I definitely get the new drug?
No, this is a 'randomized' study, meaning you will be randomly assigned to either receive erdafitinib or one of the standard treatments. Neither you nor your doctor can choose which one you get.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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