A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy alone versus Neoadjuvant Chemotherapy plus Nivolumab or Nivolumab and BMS- 986205, Followed by Continued Post- Surgery Therapy with Nivolumab or Nivolumab and BMS-986205 in Participants with Muscle-Invasive Bladder Cancer
This important study is for people with bladder cancer that has spread into the muscle wall. Doctors want to find out if adding new immunotherapy drugs, such as Nivolumab, to chemotherapy before and after surgery works better than chemotherapy alone. Immunotherapy helps your body's own immune system fight cancer. The researchers will be looking at how many people have no cancer found after surgery (called a 'complete response') and how long people live without the cancer returning or getting worse. They will also carefully check for any side effects. The goal is to find more effective and safer ways to treat muscle-invasive bladder cancer.
At a glance
What is this study about?
This study is a ‘Phase 3’ trial, which means it's testing new treatments on a larger group of people to confirm if they are safe and work better than existing options. It focuses on a type of bladder cancer that has grown into the muscle, known as 'muscle-invasive bladder cancer'. This is a serious type of bladder cancer, and doctors are always looking for better ways to treat it. The standard treatment often involves chemotherapy before surgery to shrink the tumour, followed by surgery to remove the bladder.
In this study, researchers are comparing two main approaches. One group of patients will receive the standard chemotherapy before surgery. Another group will get chemotherapy along with a new type of drug called an immunotherapy, specifically Nivolumab, and potentially another similar drug (BMS-986205). Immunotherapy drugs work differently from chemotherapy; they help your body's own immune system recognise and attack cancer cells. After surgery, patients in the immunotherapy groups will continue to receive these drugs to help prevent the cancer from coming back.
The main aim of the study is to see if adding these immunotherapy drugs improves how well the treatment works. They will measure things like how many people have no cancer left after surgery (a 'pathological complete response'), and how long people live without the cancer returning or getting worse. They will also closely monitor any side effects from these new treatments to make sure they are safe. The hope is that this research will lead to better treatment options for people with muscle-invasive bladder cancer.
Key takeaways
- Compares standard treatment with new immunotherapy drugs.
- For people with bladder cancer that has spread into the muscle.
- Aims to find out if new treatments are more effective and safer.
- Involves treatment before and after surgery.
- Patients need to be 18 years or older and suitable for treatment.
Who may be eligible?
To be considered for this study, you must be an adult aged 18 or older. The study is open to both men and women.
More detailed criteria would generally apply, such as having a confirmed diagnosis of muscle-invasive bladder cancer that hasn't spread to distant parts of the body. You would also need to be well enough to receive the treatments, with your doctors checking your overall health, organ function, and previous medical history. You usually can't have other active cancers or certain other medical conditions.
Before joining, you'll have several tests to ensure this study is a suitable and safe option for you. Your specialist will discuss all the specific requirements in detail and help you understand if you might be eligible.
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 bladder cancer that has grown into the muscle?
- Are you able to undergo chemotherapy and potentially immunotherapy?
- Are you generally well enough for treatment and surgery?
What does participation involve?
If you decide to take part, you'll be randomly assigned to one of the treatment groups – either standard chemotherapy alone or chemotherapy combined with immunotherapy. This random assignment is like flipping a coin and ensures the groups are compared fairly. You will receive treatments before surgery, followed by the surgery itself. After surgery, some groups will continue to receive medication for a period of time. You'll have regular hospital visits for your treatments, blood tests, scans, and other check-ups to monitor your health and the treatment's effect. The total duration of your participation, including follow-up after all treatments are finished, will be explained in full by the study team. This follow-up will involve regular check-ups, potentially over several years, to track your long-term health and if the cancer returns.
Potential risks and benefits
Locations (11)
- —UnverifiedGermany
- —UnverifiedNorway
- —UnverifiedFrance
- —UnverifiedFinland
- —UnverifiedRomania
- —UnverifiedAustria
- —UnverifiedSpain
- —UnverifiedNetherlands
- —UnverifiedBelgium
- —UnverifiedItaly
- —UnverifiedGreece
Common questions
What is 'muscle-invasive bladder cancer'?
It's bladder cancer that has grown into the muscular wall of the bladder.
What is 'immunotherapy'?
It's a type of treatment that helps your body's own immune system find and kill cancer cells.
What does 'randomised' mean in a study?
It means you're put into a treatment group by chance, like drawing lots, to ensure a fair comparison.
What is a 'Phase 3' study?
It's a large study testing if a new treatment is better than, or as good as, current standard treatments.
Will I still have surgery if I join this study?
Yes, surgery to remove the bladder is a key part of the treatment for all patients in this study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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