Phase II non randomized clinical trial of NIVOLUMAB/IPILIMUMAB maintenance following first-line chemotherapy in unresectable locally advanced or metastatic urothelial cancer (SOGUG-VEXILLUM)
This research study, called SOGUG-VEXILLUM, is investigating two new medicines, nivolumab (also known as OPDIVO) and ipilimumab (also known as YERVOY), for advanced bladder cancer that has spread or can't be operated on. Participants will receive these medicines after they've had their first round of chemotherapy. The main goal is to see how long people live without their cancer getting worse. Researchers will also look at overall survival, how many people respond to the treatment, and side effects. This study is for adults aged 18 and over, both men and women.
At a glance
What is this study about?
This study is about a type of cancer that starts in the bladder, called urothelial cancer. When this cancer has grown and spread (we call it 'advanced' or 'metastatic'), or if it's in a place that makes it too difficult to remove with surgery, doctors look for treatments to help manage it. Often, the first treatment is chemotherapy to try and shrink the cancer.
This particular study is looking at what happens *after* that initial chemotherapy. It's testing two medicines, nivolumab (you might hear it called OPDIVO) and ipilimumab (YERVOY). These medicines are a type of treatment called immunotherapy, which helps your own body's immune system fight the cancer. The researchers want to see if continuing with these medicines after chemotherapy can help stop the cancer from growing or spreading for longer.
The main thing the study will measure is how long people live without their cancer growing or getting worse. This is an important way to see how effective a new treatment might be. They will also look at how long people live overall, how much the cancer shrinks, and any side effects people experience. This information will help doctors understand if this combination of medicines is a good option for people with this type of advanced bladder cancer.
Key takeaways
- Tests new medicines (nivolumab and ipilimumab) for advanced bladder cancer.
- Medicines are given after initial chemotherapy.
- Aims to see if cancer growth can be stopped for longer.
- Also monitors overall survival and side effects.
- For adults (18+) with unresectable/metastatic urothelial cancer.
Who may be eligible?
To join this study, you need to be an adult, at least 18 years old, and can be a man or a woman. The study is specifically for people who have been diagnosed with advanced urothelial cancer. This means your bladder cancer has either spread to other parts of your body (metastatic) or is in a location that makes it impossible to remove by surgery (locally advanced).
Additionally, you must have already completed your first round of chemotherapy for this advanced cancer. The study is investigating if adding these new medicines *after* chemotherapy helps. The research team will review your full medical history and current health to make sure this study is right for you and that you meet all the other specific health requirements.
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 advanced bladder cancer (urothelial cancer)?
- Can your bladder cancer not be removed by surgery or has it spread?
- Have you already finished your first course of chemotherapy for your bladder cancer?
What does participation involve?
If you join this study, you will receive the study medicines, nivolumab and ipilimumab, as an infusion (through a drip into your vein) after you have finished your initial chemotherapy. The study team will schedule regular visits for you to receive these treatments and to have check-ups. During these visits, you will have various tests, like blood tests and scans, to monitor your health and see how the treatment is affecting your cancer. You'll also be asked to fill out questionnaires about how you're feeling and your quality of life, which helps researchers understand the full impact of the treatment. The total duration of your participation will depend on how you respond to the treatment and the study's protocol, but you would be monitored closely throughout.
Potential risks and benefits
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Common questions
What type of cancer is this study for?
This study is for advanced bladder cancer (urothelial cancer) that has spread or can't be removed with surgery.
What medicines are being studied?
The study is looking at two medicines called nivolumab (Opdivo) and ipilimumab (Yervoy).
When are these medicines given?
These medicines are given after a person has already completed their first course of chemotherapy for their advanced bladder cancer.
What is the main goal of the study?
The main goal is to see how long people live without their cancer getting worse, and to look at other things like overall survival and side effects.
Who can take part in this study?
Adults aged 18 and over, both men and women, with this specific type of advanced bladder cancer who have completed their first chemotherapy.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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