Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
This clinical trial is designed for people who have intermediate-risk non-muscle invasive bladder cancer (NMIBC). This type of bladder cancer has not spread into the deeper muscle of the bladder wall. The study is investigating a new gene therapy called Nadofaragene Firadenovec. Participants will either receive this new treatment or be carefully monitored, without immediate active treatment, to compare which approach is more effective at preventing the cancer from coming back. This is a Phase 3 study, meaning the treatment has already shown promise in earlier stages and is now being tested on a larger group of people to confirm its safety and effectiveness.
At a glance
What is this study about?
This study is looking into a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC). This means the cancer is only in the inner lining of the bladder and hasn't grown into the muscle layer. Specifically, it's for people with "intermediate-risk" NMIBC, which means there's a moderate chance the cancer could return. The main goal is to see if a new treatment, Nadofaragene Firadenovec, can help prevent the cancer from coming back.
Nadofaragene Firadenovec is a type of gene therapy. This treatment works by delivering a specific gene into the bladder cells. The hope is that this gene will make the bladder cells produce a protein that helps the body's immune system fight the cancer. This study will compare how well this new treatment works against simply watching the cancer closely (observation) after an initial surgery.
By taking part, you would be helping researchers understand if this new gene therapy is a safe and effective way to manage intermediate-risk NMIBC. The results could potentially offer a new treatment option for many people with this condition and improve their long-term health.
Key takeaways
- This study is for intermediate-risk, non-muscle invasive bladder cancer.
- It tests a new gene therapy called Nadofaragene Firadenovec.
- Compares the new treatment to close monitoring (observation).
- Participation involves regular check-ups and monitoring.
- You will be randomly assigned to a treatment group.
- Aims to find a new way to prevent bladder cancer from returning.
Who may be eligible?
To join this study, you must have been diagnosed with intermediate-risk non-muscle invasive bladder cancer (NMIBC). This diagnosis needs to be confirmed by medical guidelines. You also need to have had an operation called a transurethral resection of bladder tumour (TURBT) within the last 60 days to remove the cancer.
There are certain conditions that would mean you couldn't take part. For example, if your bladder cancer has spread into the deeper muscle layer or to other parts of your body, or if you have a different type of bladder cancer considered high-risk or low-risk according to specific medical definitions. Also, if you have certain other serious health problems, you might not be suitable.
The study is open to both men and women, aged 18 years and older. Your doctor will carefully review your medical history and test results to see if this study is the right fit for you.
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.
- I have been diagnosed with intermediate-risk non-muscle invasive bladder cancer.
- I had surgery (TURBT) to remove the bladder tumour within the last 60 days.
- My cancer has not spread into the bladder muscle or other parts of my body.
- I am 18 years old or older.
What does participation involve?
Taking part in this study means you would be randomly assigned to either receive the new gene therapy or be in the observation group. You wouldn't get to choose which group you are in. The study involves regular visits to the clinic for check-ups, tests, and to receive the treatment if you are in that group. You would be carefully monitored throughout the study, which will likely involve urine tests, bladder examinations (like cystoscopy), and scans. The total duration of your participation would be discussed with you by the research team, as these types of studies often involve several years of follow-up to track the cancer's behaviour.
Potential risks and benefits
Locations (98)
- University of South Alabama (USA) Health System - USACMVerified postcodeMobile, United States· Recruiting
- Urology Associates of MobileVerified postcodeMobile, United States· Recruiting
- Mayo Clinic ArizonaVerified postcodePhoenix, United States· Recruiting
- Center for NeurosciencesVerified postcodeTucson, United States· Recruiting
- Arkansas Urology, North Little RockVerified postcodeLittle Rock, United States· Recruiting
- Michael G Oefelein, MD Clinical TrialsVerified postcodeBakersfield, United States· Recruiting
- Urology Associates of Central CaliforniaVerified postcodeFresno, United States· Recruiting
- American Institute of ResearchVerified postcodeLos Angeles, United States· Recruiting
- Urology Center of Southern CaliforniaVerified postcodeMurrieta, United States· Recruiting
- University of California, IrvineVerified postcodeOrange, United States· Recruiting
- Providence Saint John's Cancer InstituteVerified postcodeSanta Monica, United States· Recruiting
- Advent HealthVerified postcodeDenver, United States· Recruiting
Common questions
What is 'intermediate-risk non-muscle invasive bladder cancer'?
It's a type of bladder cancer that's only in the lining of the bladder, not the deeper muscle, and has a moderate chance of coming back.
What is Nadofaragene Firadenovec?
It's a new experimental gene therapy being tested to help the body's immune system fight bladder cancer.
Will I definitely get the new treatment if I join?
No, participants are randomly assigned to either receive the new treatment or be closely monitored. You won't get to choose.
What does 'randomized' mean?
It means you'll be put into one of the study groups by chance, like flipping a coin, to ensure a fair comparison.
How long will I be in the study?
Clinical trials often involve long-term follow-up to track health outcomes, so it could be several years. The team will provide specifics.
How to find out more
Ferring Pharmaceuticals
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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