A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer
This study is for people with a common type of bladder cancer that hasn't spread into the muscle, called non-muscle invasive bladder cancer. We are testing a new treatment called TAR-210 to see if it's more effective than standard chemotherapy treatments like Gemcitabine or MMC (Mitomycin C). The main goal is to find out if TAR-210 can keep the cancer from coming back for longer. This is a Phase 3 study, meaning it's one of the final steps before a new treatment might become widely available. We are also looking if the cancer has a specific change (mutation or fusion) in a gene called FGFR which might make the new treatment more effective.
Överblick
Vad handlar denna studie om?
This clinical trial is designed for people who have a specific type of bladder cancer known as Non-Muscle Invasive Bladder Neoplasms. This means the cancer cells are found in the lining of the bladder but haven't grown into the deeper muscle layer. It's a common form of bladder cancer, and treatments usually aim to remove the cancer and prevent it from returning.
The study is comparing two different approaches. One group of participants will receive a new treatment called TAR-210. The other group will receive standard chemotherapy treatments that are usually put directly into the bladder, such as Gemcitabine or MMC. The main reason for doing this study is to see which treatment is better at stopping the cancer from coming back after it's been removed.
Researchers are particularly interested in how long people stay 'disease-free,' meaning how long it takes before the cancer reappears. They are also looking at whether having a specific genetic change, called an 'FGFR mutation or fusion,' affects how well TAR-210 works. This information could help doctors decide if TAR-210 is a good option for certain patients in the future.
Viktiga punkter
- This study compares a new bladder cancer treatment (TAR-210) with standard chemotherapy.
- It's for a common type of bladder cancer that hasn't spread to the bladder muscle.
- The main goal is to see which treatment keeps the cancer away for longer.
- You would undergo regular bladder checks and assessments if you join.
- Having a specific genetic change (FGFR mutation or fusion) is important for eligibility.
- Deltagande är frivilligt, och du kan dra dig ur när som helst.
Vem kan vara berättigad?
To join this study, you must have a recent diagnosis (within the last 3 months) of a specific type of non-muscle invasive bladder cancer. This includes certain types of low-grade tumours, especially if they have some risk factors, such as multiple tumours, a larger single tumour (3cm or more), or if the cancer has come back quickly or often after previous treatment. For some parts of the study, your doctor will need to decide that MMC (a common chemotherapy drug) would be the usual treatment for you.
Another important requirement is that your cancer cells, or your urine, must show a specific genetic change called an 'FGFR mutation or fusion.' This will be checked by special tests. You must also be generally well enough to take part in the study activities and be willing to undergo regular bladder examinations (cystoscopies) and any necessary additional surgeries to remove cancer if it returns.
There are also reasons why you might not be able to join. For example, if you have known allergies to certain medicines or substances (we can't list them all here), this study might not be right for you. Your study doctor will discuss all the specific details to make sure you're a good fit for the trial.
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- Have you been diagnosed with non-muscle invasive bladder cancer recently?
- Does your cancer have specific risk factors, like recurring often?
- Has your doctor confirmed that your cancer shows an 'FGFR mutation or fusion'?
- Are you able and willing to have regular bladder examinations (cystoscopies)?
- Are you generally well and active enough for daily tasks?
Vad innebär deltagande?
If you join this study, you will be randomly assigned to either receive the new treatment, TAR-210, or one of the standard chemotherapy treatments (Gemcitabine or MMC) put directly into your bladder. This means you won't get to choose which treatment you receive. You will need to have several check-ups, including regular bladder examinations (cystoscopies) throughout the study and potentially a procedure called a TURBT (Transurethral Resection of Bladder Tumor) if the cancer comes back or gets worse, to assess your condition.
The overall duration of your involvement in the study will vary, but it will involve ongoing monitoring to see how well the treatment is working and to keep track of your health. Your study team will explain the full schedule of visits, treatments, and follow-up appointments, so you know exactly what to expect from start to finish.
Potentiella risker och fördelar
Locations (193)
- Arkansas UrologyVerifierat postnummerLittle Rock, USA· Avslutad
- Genesis Research LLCVerifierat postnummerLos Alamitos, USA· Aktiv men inte rekryterande
- USC Norris Omfattande CancercenterVerifierat postnummerLos Angeles, USA· Aktiv men inte rekryterande
- University of California Irvine Medical CenterVerifierat postnummerOrange, USA· Aktiv men inte rekryterande
- Om Research LLCVerifierat postnummerSan Diego, USA· Aktiv men inte rekryterande
- Genesis Research LLC 1Verifierat postnummerSherman Oaks, United States· Avslutad
- University of Colorado Cancer Center Anschultz Cancer PavilionVerifierat postnummerAurora, USA· Avslutad
- Colorado Clinical ResearchVerifierat postnummerLakewood, USA· Aktiv men inte rekryterande
- Moffitt Cancer CenterVerifierat postnummerTampa, USA· Aktiv men inte rekryterande
- Northwestern UniversityVerifierat postnummerChicago, USA· Avslutad
- First UrologyVerifierat postnummerJeffersonville, United States· Avslutad
- Wichita Urology GroupVerifierat postnummerWichita, United States· Aktiv men inte rekryterande
Vanliga frågor
What is Non-Muscle Invasive Bladder Neoplasms?
It's a type of bladder cancer where the cancer cells are only in the bladder's inner lining and haven't spread to the deeper muscle.
What does 'Phase 3' mean for a drug trial?
Phase 3 means this is one of the final stages of testing. It compares the new treatment with existing ones to prove it's safe and effective before it can be widely used.
Vad är TAR-210?
TAR-210 is a new treatment being tested for bladder cancer. The study aims to see how well it works compared to current standard treatments.
What is an 'FGFR mutation or fusion'?
It's a specific change in a gene (called FGFR) that can happen in some bladder cancers. Researchers are studying if this change helps predict if TAR-210 will work well.
Will I get to choose my treatment?
No, you will be randomly assigned to either receive TAR-210 or a standard chemotherapy treatment. This is to ensure the study results are fair and unbiased.
Hur du får reda på mer
Studiekontakt
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Diskussion
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