A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-risk Muscle-invasive Urothelial Carcinoma (MIUC)
This study is investigating a new treatment for a serious type of bladder cancer that has spread into the muscle, called muscle-invasive urothelial carcinoma (MIUC). We want to find out if combining an experimental drug called autogene cevumeran with an existing medicine, nivolumab, is more effective and safe than using nivolumab on its own after surgery. The study will first check the safety of the combination treatment in a small group. Then, more participants will be randomly assigned to receive either the combination treatment or nivolumab plus an inactive substance (like salt water). The goal is to see if this new combination can help people with high-risk MIUC after their surgery.
At a glance
What is this study about?
This study is about a type of cancer that affects the bladder, called muscle-invasive urothelial carcinoma (MIUC). This means the cancer has grown into the muscle layer of the bladder wall. For many people with this cancer, surgery to remove the bladder is a common treatment. However, even after surgery, there's a risk the cancer could return, especially if it's considered 'high-risk'.
Researchers are investigating a new way to try and stop the cancer from coming back. This involves two medicines: autogene cevumeran, which is still being tested, and nivolumab, which is already used to treat some cancers. Nivolumab helps your body's immune system fight cancer. Autogene cevumeran is designed to specifically target the cancer cells in MIUC. The study wants to see if giving both medicines together after surgery works better and is safer than giving nivolumab on its own.
The main aim is to understand if this combined treatment can help prevent the cancer from returning in people who have had their MIUC removed by surgery. This is a "Phase 2" study, which means it builds on earlier research and aims to get a better idea of how well the treatment works and what side effects it might have, before potentially moving on to larger studies.
Key takeaways
- This study evaluates a new combination treatment for high-risk bladder cancer.
- It compares an experimental drug plus nivolumab against nivolumab alone after surgery.
- Participants will be randomly assigned to different treatment groups.
- The main goals are to check how safe and effective the new treatment is.
- It's a Phase 2 study, building on earlier research.
- You can withdraw from the study at any time if you choose.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. You need to have been diagnosed with muscle-invasive urothelial carcinoma (MIUC) of the bladder or upper urinary tract, and this diagnosis must have been confirmed by a doctor.
You must also have had surgery to remove your MIUC, and your doctors will have checked that the cancer has not spread to other parts of your body after the surgery. It’s important that you have recovered well from your surgery within 120 days of the operation. You may have had chemotherapy before your surgery, or you might not have had any prior chemotherapy if your doctor decided you couldn't have it for specific reasons.
There are also some health checks you'll need to pass, like having a good general health status and testing negative for certain infections like HIV and Hepatitis B and C (or having certain results if you've been exposed previously). You'll also need to provide a sample of your tumour tissue for further testing.
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 muscle-invasive urothelial carcinoma (MIUC)?
- Have you recently had surgery to remove your MIUC and recovered well?
- Has your doctor confirmed your cancer has not spread to other parts of your body after surgery?
- Are you able to attend regular appointments for tests and treatment?
What does participation involve?
If you decide to join this study, you'll first be part of a short 'safety check' phase where you'll receive the combination of autogene cevumeran and nivolumab. This is to make sure the treatment is safe for everyone before more people join. After this initial check, if you continue in the study, there's a chance you'll be randomly assigned to one of two groups: one group will receive autogene cevumeran plus nivolumab, and the other group will receive nivolumab along with an inactive substance (like a saltwater solution).
Throughout the study, you'll have regular hospital visits for assessments. This will involve physical examinations, blood tests, and scans (like CT or MRI scans) to monitor your health and how the treatment is working. You'll receive the study medication as prescribed by the research team. The total time you'll be involved in the study, including treatments and follow-up appointments, will be clearly explained to you by the study doctor.
Potential risks and benefits
Locations (107)
- Highlands Oncology Group.Verified postcodeSpringdale, United States· Recruiting
- Kaiser Permanente - Baldwin ParkVerified postcodeBaldwin Park, United States· Recruiting
- City of Hope Cancer CenterVerified postcodeDuarte, United States· Withdrawn
- Kaiser Permanente - Los Angeles (N. Vermont)Verified postcodeLos Angeles, United States· Recruiting
- Kaiser Permanente - RiversideVerified postcodeRiverside, United States· Recruiting
- University of California San FranciscoVerified postcodeSan Francisco, United States· Recruiting
- Yale Cancer CenterVerified postcodeNew Haven, United States· Withdrawn
- Georgetown University Medical Center Lombardi Cancer CenterVerified postcodeWashington D.C., United States· Withdrawn
- Norton Cancer InstituteVerified postcodeLouisville, United States· Withdrawn
- Henry Ford Health SystemVerified postcodeDetroit, United States· Withdrawn
- Memorial Sloan Kettering Cancer Center Basking RidgeVerified postcodeBasking Ridge, United States· Recruiting
- MSK MonmouthVerified postcodeMiddletown, United States· Recruiting
Common questions
What is muscle-invasive urothelial carcinoma (MIUC)?
It's a type of cancer that has grown into the muscle wall of the bladder or upper urinary tract. It's considered a serious form of bladder cancer.
What are autogene cevumeran and nivolumab?
Autogene cevumeran is a new, experimental drug that aims to help your body fight cancer. Nivolumab is an existing medicine that boosts your immune system to attack cancer cells.
Will I definitely get the new combined treatment?
If you join the main part of the study, you have a chance of receiving the combination of autogene cevumeran and nivolumab, or nivolumab alone with an inactive substance. It's decided randomly, like flipping a coin.
Why is this study important?
This study aims to find out if a new combination of treatments can help prevent MIUC from returning after surgery, potentially offering a better outcome for patients.
How long will I be in the study?
The exact duration for you will be explained by the study team, as it includes treatment periods and follow-up appointments. It will last for a specific period of time to monitor how you're doing.
How to find out more
Reference Study ID Number: BO45230 https://forpatients.roche.com/
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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