TALazoparib and Avelumab as maintenance therapy in platinum-Sensitive metastatic or locally advanced URothelial carcinoma: A single-arm Phase 2 trial
This research study is for adults with advanced bladder cancer that has responded well to their first treatment with platinum-based chemotherapy. The study is investigating two medicines, talazoparib and avelumab, given together after chemotherapy has finished. This is called 'maintenance therapy' because its goal is to help keep the cancer under control and prevent it from growing again. It's a Phase 2 trial, which means the researchers want to learn more about how well this combination works and if it's safe. It's a single-arm study, meaning everyone in the study will receive the same treatment. The hope is to find a new way to help people with this type of cancer live longer and with better quality of life.
At a glance
What is this study about?
This study is about a type of cancer called urothelial carcinoma, which most often affects the bladder, but can also be found in other parts of the urinary system. When this cancer is advanced, it means it has spread to other parts of the body or is locally advanced, meaning it has grown significantly in its original area. For these types of cancers, patients often start with chemotherapy drugs that contain platinum. These drugs are good at shrinking the cancer.
Once the initial chemotherapy has worked well and reduced the cancer, doctors want to find ways to keep the cancer from growing back. This is where 'maintenance therapy' comes in. This study is testing two specific drugs, talazoparib and avelumab, used together after the successful chemotherapy. Talazoparib works by targeting cancer cells in a particular way, while avelumab is an immunotherapy drug that helps your own immune system fight the cancer.
The main goal of this Phase 2 study is to see how well these two drugs, when given together as maintenance therapy, can help prevent the cancer from returning or growing again. Researchers will also be looking closely at any side effects to understand how safe the combination is. Finding effective maintenance treatments is really important for people with advanced bladder cancer, as it could lead to longer periods where the cancer is under control and improve overall health.
Key takeaways
- This study is for advanced bladder cancer that has responded to chemotherapy.
- It tests two drugs, talazoparib and avelumab, as 'maintenance' treatment.
- The goal is to stop the cancer from growing back for longer.
- It's a Phase 2 study looking at how well the combination works and if it's safe.
- All participants will receive the study drugs.
- You'll have regular checks and follow-up during the study.
Who may be eligible?
This study is looking for adults aged 18 or over. It doesn't matter if you are male or female; anyone can take part.
You might be able to join if you have been diagnosed with advanced bladder cancer (urothelial carcinoma) that has either spread to other parts of your body or is locally advanced. A key part of qualifying is that your cancer must have responded well to previous treatment with chemotherapy drugs that contain platinum. This means your cancer would have shrunk or stopped growing after that initial treatment.
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?
- Do you have advanced bladder cancer (urothelial carcinoma)?
- Has your cancer responded well to platinum-based chemotherapy?
- Are you able to attend regular hospital visits for treatment and checks?
What does participation involve?
If you decide to take part in this study, you will receive the two study drugs, talazoparib and avelumab, after your initial chemotherapy has finished. The study team will explain exactly how often and for how long you'll take these medicines. You'll have regular hospital visits for check-ups, blood tests, and scans to see how you are doing and how the treatment is working. The doctors and nurses will also watch carefully for any side effects you might experience. The total length of your participation will depend on how you respond to the treatment, but the team will discuss the expected duration with you.
Potential risks and benefits
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Common questions
What is 'urothelial carcinoma'?
It's a common type of cancer that usually starts in the lining of the bladder, but can also be found in other parts of the urinary system.
What does 'maintenance therapy' mean?
It's treatment given after initial therapy has worked well, to help keep the cancer from growing back or spreading for as long as possible.
What is a 'Phase 2' trial?
In a Phase 2 trial, researchers are testing if a new treatment works for a specific type of cancer and to learn more about its safety and side effects.
Will I get a placebo (dummy treatment)?
No, in this study, everyone who takes part will receive both study drugs, talazoparib and avelumab.
What if I get side effects?
The study team will monitor you closely for any side effects and provide care and support to help manage them.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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