A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab versus Placebo in Subjects with High Risk Invasive Urothelial Carcinoma
This clinical trial is testing whether an immunotherapy drug called nivolumab can stop urothelial cancer (cancer of the bladder or urinary tract) from returning after surgery. When cancer has a high risk of coming back, extra treatment given after surgery is called adjuvant therapy. Participants will receive either nivolumab or a dummy treatment (placebo) through a drip. Neither the patient nor their care team will choose or know which one they receive. The study focuses on how long people stay cancer-free, looking closely at whether a specific marker on cancer cells, called PD-L1, changes how well the drug works. The trial is open to adults aged 18 and over who have had surgery for invasive urothelial cancer that is at high risk of returning. Taking part helps doctors understand if this medicine should become a standard treatment.
At a glance
What is this study about?
Urothelial cancer is the most common form of bladder cancer, and it can also start in other parts of the urinary system, such as the tubes connecting the kidneys to the bladder. In some cases, the cancer grows deeply into the surrounding tissue. Even after successful surgery to remove the tumour, tiny cancer cells can sometimes remain behind, meaning there is a high risk the cancer could return.
This trial investigates a drug called nivolumab (also known as Opdivo). Nivolumab is an immunotherapy, which means it works by helping your body's own immune system recognise and attack cancer cells. In this study, it is being tested as an 'adjuvant' treatment—a therapy given after main surgery to help lower the chances of the disease coming back.
Researchers are comparing nivolumab directly against a placebo (an inactive dummy drip). They want to see if nivolumab genuinely keeps people free from cancer for longer, and whether it helps people live longer overall. They are also testing whether the drug works better in people whose tumours have a protein called PD-L1, which can affect how the immune system responds.
Key takeaways
- Tests whether nivolumab prevents bladder or urinary tract cancer from returning after surgery.
- Compares the active immunotherapy drug against an inactive placebo drip.
- Open to adults aged 18 and over with high-risk invasive urothelial cancer.
- Treatment lasts up to one year, followed by long-term health check-ups.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is open to men and women aged 18 or older who have been diagnosed with invasive urothelial cancer. To be considered, you must have already had surgery to remove the tumour, and your medical team must have determined that the cancer has a high risk of coming back.
Your tumour tissue will be checked in a laboratory to see if it carries certain markers, such as PD-L1, although people with and without this marker may still be able to join. You will also need to be well enough to carry out everyday activities and attend regular hospital appointments.
You might not be able to take part if you have certain other serious health conditions, active autoimmune disorders, or if you have already had specific treatments that interfere with the study drug. Your hospital doctor can check your medical history to see if you qualify.
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 invasive urothelial (bladder or urinary tract) cancer.
- I have had surgery to remove the cancer.
- My doctor has told me my cancer has a high risk of returning.
- I am well enough to attend regular hospital appointments for treatment and scans.
What does participation involve?
If you decide to take part, you will be placed into one of two groups by chance (randomly). One group receives nivolumab, and the other receives a placebo. The treatment is given through a drip into a vein (an intravenous infusion) at a hospital clinic, typically every few weeks.
You will need to attend regular hospital visits for health checks, blood tests, and scans (such as CT or MRI scans) to monitor your progress and see if the cancer has returned. The active treatment usually lasts for up to one year, provided the cancer does not come back and you do not experience severe side effects.
After finishing the treatment, you will enter a follow-up period. The research team will continue to check on your health and well-being with regular clinic visits or phone calls for several years.
Potential risks and benefits
Locations (13)
- —UnverifiedFrance
- —UnverifiedDenmark
- —UnverifiedGreece
- —UnverifiedRomania
- —UnverifiedGermany
- —UnverifiedAustria
- —UnverifiedNetherlands
- —UnverifiedIreland
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedSweden
- —UnverifiedBelgium
Common questions
What is a placebo and why is it used?
A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps doctors prove whether the effects seen are truly caused by the study medicine.
Will I know if I am getting nivolumab or the placebo?
No. This is a 'double-blind' study, meaning neither you nor your doctor will know which treatment you are receiving, to keep the test fair.
How is the medicine given?
Both nivolumab and the placebo are given as a liquid drip into a vein at the hospital.
Can I leave the study if I change my mind?
Yes. You can leave the trial at any point, for any reason, and your medical team will continue to give you standard care.
Do I have to pay to take part?
No, clinical trial medicines and extra tests are provided free of charge through the trial.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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