A phase 1b-2 study of mitomycin-C / capecitabine chemoradiotherapy combined with ipilumimab and nivolumab or nivolumab monotherapy as bladder sparing curative treatment for muscle invasive bladder cancer: the CRIMI study
Muscle-invasive bladder cancer is a serious condition where cancer cells have spread into the deep muscle wall of the bladder. The usual major surgery involves removing the bladder completely, which significantly impacts daily life. This trial, called the CRIMI study, investigates an alternative approach aimed at saving the bladder. Participants will receive standard chemoradiotherapy (radiation combined with chemotherapy drugs mitomycin-C and capecitabine) alongside immunotherapy drugs called nivolumab and ipilimumab. Immunotherapy helps the body's natural immune system fight cancer cells. The trial has two stages. The first stage looks at safety and side effects to find the best dose. The second stage measures how well this combined treatment keeps people free of cancer over time. Doctors hope this approach provides an effective cure while allowing patients to keep their bladder working normally.
At a glance
What is this study about?
Bladder cancer often starts in the inner lining of the organ. When it spreads deeper into the muscle layer, doctors call it muscle-invasive bladder cancer. Traditionally, curing this stage of cancer often means major surgery to remove the entire bladder. While this surgery can be life-saving, it changes how a person passes urine permanently and can have a large impact on quality of life. Doctors are searching for better ways to clear the cancer while safely keeping the bladder intact.
One existing alternative is chemoradiotherapy, which uses targeted radiation alongside low doses of chemotherapy to attack cancer cells. The CRIMI clinical trial aims to boost this treatment by adding immunotherapy drugs called nivolumab and ipilimumab. Instead of attacking cancer directly, immunotherapy works by 'switching on' the body's own immune system so it can recognise and destroy cancer cells more effectively.
This trial is divided into two parts. In the first phase, doctors want to find out how safe the combination is and monitor any side effects closely during the first six weeks. In the second phase, researchers will measure how successful the treatment is at stopping the cancer from coming back and helping people live longer, healthier lives. If successful, this research could offer future patients a safe, bladder-sparing alternative to major surgery.
Key takeaways
- The study tests a new combination of immunotherapy and chemoradiotherapy.
- It aims to treat muscle-invasive bladder cancer without needing to remove the bladder.
- The trial checks both the safety of the combination and how well it prevents cancer from returning.
- Participants receive treatment through tablets, drips, and radiation sessions.
- Taking part is voluntary, and you are closely monitored throughout.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with muscle-invasive bladder cancer. Both men and women can take part. It is designed for individuals who are seeking a curative treatment that aims to preserve the bladder rather than having it surgically removed.
Because this trial involves multiple powerful treatments, you will need to be well enough overall to manage chemotherapy, radiotherapy, and immunotherapy. Your doctor will check your general fitness, kidney function, and heart health to make sure the combination is suitable for you.
People who have already had certain pelvic treatments, those with active autoimmune diseases, or individuals with severe medical conditions that make cancer therapy unsafe may not be able to join. The trial team will review your full medical history with you to ensure taking part is appropriate.
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.
- I am aged 18 or older.
- I have been diagnosed with muscle-invasive bladder cancer.
- I am looking for a treatment option aimed at saving my bladder.
- I am generally well enough to attend hospital visits for chemotherapy, radiotherapy, and immunotherapy.
- I do not have a serious autoimmune condition that prevents me from having immunotherapy.
What does participation involve?
Taking part in this study involves receiving a combination of treatments over several weeks, followed by regular check-ups. You will receive standard radiotherapy to your bladder alongside chemotherapy, which includes tablets called capecitabine and an injection or drip of mitomycin-C. You will also receive immunotherapy drips (nivolumab on its own or paired with ipilimumab) directly into a vein at the hospital clinic.
During the first six weeks, you will visit the hospital frequently for treatment, blood tests, and health reviews so the medical team can monitor how your body handles the therapy. After finishing the initial treatment course, you will enter a follow-up period lasting several months or years. During this time, you will have routine appointments, regular scans, and camera checks of your bladder (cystoscopies) to see how well the treatment worked and ensure you remain cancer-free.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is the main goal of the CRIMI study?
The goal is to test whether adding immunotherapy to standard chemoradiotherapy is safe and effective at clearing bladder cancer while allowing patients to keep their bladder.
How is immunotherapy given?
The immunotherapy medicines, nivolumab and ipilimumab, are given as a slow drip through a small tube into a vein in your arm at the hospital.
Will I definitely get to keep my bladder?
The trial aims to preserve your bladder, but doctors will monitor your cancer closely. If the cancer does not fully go away or returns, standard surgery may still be recommended.
Do I have to pay to take part in this trial?
No, you do not pay for clinical trial medicines or tests. Your standard NHS care and trial-related hospital visits are covered.
Can I leave the study if I feel it is too much for me?
Yes. Taking part is entirely your choice. You can leave the trial at any time, for any reason, and your doctors will continue to give you the best available standard care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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