A Phase 2 Study Evaluating Futibatinib (TAS-120) Plus Pembrolizumab in the Treatment of Advanced or Metastatic Urothelial Carcinoma
This research study is investigating a new treatment approach for advanced or metastatic urothelial carcinoma, a type of bladder cancer that has spread. The study combines two medicines: futibatinib and pembrolizumab, which is also known as Keytruda. This is a Phase 2 trial, which means the main goal is to find out how effective this combination treatment is and to continue checking its safety. Researchers will be looking at how many patients respond to the treatment, meaning their tumours shrink or disappear. They will also measure how long the treatment keeps the cancer under control, how long patients live, and importantly, any side effects experienced. The study is open to adults aged 18 and over, regardless of their sex, and aims to provide more options for treating this challenging condition.
At a glance
What is this study about?
This study is testing a new way to treat advanced urothelial carcinoma, which is a type of bladder cancer that has spread to other parts of the body. When cancer spreads, it's called metastatic. The treatment being looked at combines two different medications: futibatinib and pembrolizumab. You might know pembrolizumab by its brand name, Keytruda. Both of these drugs work in different ways to fight cancer.
Futibatinib is a type of drug designed to block certain signals within cancer cells that help them grow. Pembrolizumab, on the other hand, is an immunotherapy. This means it works by helping your own body's immune system to recognise and attack cancer cells more effectively. Researchers hope that by using these two drugs together, they can achieve a stronger effect against the cancer than using either drug alone.
The main aim of this study is to see how many people respond to this new combination treatment. A response could mean that the cancer shrinks significantly, or in some cases, even disappears. The study will also be carefully monitoring how long this response lasts, how long people remain free from their cancer getting worse, and overall survival. Safety is also a key focus, so any side effects will be closely watched and recorded.
Key takeaways
- This study is for advanced bladder cancer.
- It tests two drugs, futibatinib and pembrolizumab (Keytruda), together.
- The main goal is to see if the treatment shrinks tumours or stops them growing.
- Safety and side effects are carefully monitored.
- It's a Phase 2 study, focusing on how effective the treatment is.
Who may be eligible?
To join this study, you must be at least 18 years old. There's no upper age limit, meaning older adults can also take part. Both men and women are welcome to participate.
The study is specifically for people who have been diagnosed with advanced or metastatic urothelial carcinoma. This means your bladder cancer has either progressed locally or spread to other parts of your body.
Before you can join, the study team will need to do some checks to make sure this study is right for you and that you meet all the specific health requirements. This is to ensure your safety and that the study results are clear.
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 advanced or metastatic urothelial carcinoma (bladder cancer that has spread)?
- Are you able to attend regular clinic visits and tests?
- Are you willing to potentially receive a new, experimental treatment combination?
What does participation involve?
If you decide to take part in this study, you will be given the two study drugs, futibatinib and pembrolizumab. Pembrolizumab is given as an infusion into a vein, and futibatinib is likely taken as a tablet or capsule. You will be closely monitored throughout the study with regular visits to the clinic. These visits will involve blood tests, scans (like CT or MRI) to check on your cancer, and check-ups with the study doctors and nurses. You'll also be asked about how you're feeling and any side effects you might be having.
The study will follow you from the time you start treatment until a medical event occurs, for example, your cancer progresses, or you stop the treatment for another reason. Even after you stop the study treatment, the team will continue to follow up with you to understand the long-term effects on your health and survival. The total duration of your participation will depend on how you respond to the treatment and the study's follow-up plan, but it could involve a period of several months to a few years.
Potential risks and benefits
Locations (1)
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Common questions
What is urothelial carcinoma?
Urothelial carcinoma is the most common type of bladder cancer, which starts in the cells lining the bladder. It can sometimes affect other parts of the urinary system.
What does 'advanced or metastatic' mean?
It means the cancer has either grown significantly within the bladder area or has spread to other parts of your body, like your bones, liver, or lungs.
What are futibatinib and pembrolizumab?
Futibatinib is a newer drug designed to block specific signals in cancer cells. Pembrolizumab (Keytruda) is an immunotherapy that helps your immune system fight cancer.
Why combine these two drugs?
Researchers hope that using these two drugs together will create a more powerful effect against the cancer than using either drug on its own.
What is a Phase 2 study?
A Phase 2 study focuses on how well a new treatment works and continues to monitor its safety in a larger group of people than a Phase 1 study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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