Analysis of the efficacy and safety of two combination treatment regimens of nivolumab and ipilimumab in patients with dMMR and / or MSI metastatic colorectal cancer: A GERCOR open-label, randomized, non-comparative, two-stage phase II trial (NIPISAFE)
This research study, called NIPISAFE, is for people in the UK who have advanced bowel cancer that has spread to other parts of the body. Their cancer also has specific genetic changes known as dMMR and/or MSI. The study aims to compare two different ways of giving a combination of two medicines, nivolumab (brand name OPDIVO) and ipilimumab (brand name YERVOY). Both are given as an infusion, which means they are delivered directly into your bloodstream. It's a Phase II study, which means researchers are carefully checking how safe these treatments are and how effectively they can slow down or stop the cancer from growing, particularly over the first six months. The study is also looking at side effects and how patients feel during treatment.
At a glance
What is this study about?
This study is called NIPISAFE and it's looking into new ways to treat advanced bowel cancer (colorectal cancer) that has spread to other parts of the body. For this study, the cancer must also have particular genetic changes, known as dMMR (mismatch repair deficient) and/or MSI (microsatellite instability). These genetic changes can sometimes mean certain treatments might work differently.
The main goal of this study is to see how safe two different combinations of medicines, nivolumab and ipilimumab, are for patients. It's also observing how well these treatments work in stopping the cancer from growing or getting worse over the first 24 weeks (about six months). These medicines are types of immunotherapy, which help your body's own immune system fight cancer.
Researchers will be carefully tracking any side effects patients might experience, how patients' quality of life changes, and how long the cancer stays stable. By comparing two different ways of giving these medicines, doctors hope to find the best and safest approach for future treatments for this specific type of advanced bowel cancer.
Key takeaways
- This study is for advanced bowel cancer with specific genetic changes.
- It's testing two ways of giving immunotherapy drugs (nivolumab and ipilimumab).
- Main goals are to check safety and how well the treatment controls cancer growth.
- Participation involves regular hospital visits for treatment and check-ups.
- Your cancer must have dMMR and/or MSI genetic changes.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women. You must have advanced bowel cancer that has spread to other parts of your body. Additionally, your cancer needs to have specific genetic changes called dMMR and/or MSI. These are important characteristics doctors will check for to see if your cancer fits the study criteria.
There will also be other requirements, such as your general health, how well your liver and kidneys are working, and if you have any other serious health conditions that might make the treatment unsafe for you. Your specialist doctor will conduct a thorough check to see if this study is right for you, based on all the detailed rules for participating.
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 bowel cancer that has spread?
- Has your cancer been tested and found to have 'dMMR' and/or 'MSI' genetic changes?
- Are you able to attend regular hospital appointments for treatment and monitoring?
- Discuss with your doctor if you have other serious health conditions.
What does participation involve?
If you decide to take part in this study, you will receive either nivolumab and ipilimumab through a drip into your vein (an infusion), given in one of two different ways. The treatment schedule will involve regular visits to the hospital or clinic for these infusions and for monitoring appointments. During these visits, doctors will closely check how you are responding to the treatment and look for any side effects.
This will involve physical examinations, blood tests, and scans (like CT scans) to see if the cancer is growing or shrinking. You will also be asked to complete questionnaires about how you are feeling and your quality of life. The study will look closely at what happens during the first six months of treatment, but you will be monitored for up to two years or even longer, depending on how your treatment progresses. Throughout the study, medical staff will be available to support you and answer any questions.
Potential risks and benefits
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Common questions
What are nivolumab and ipilimumab?
These are types of immunotherapy medicines that help your body's immune system recognise and fight cancer cells.
What does 'dMMR and/or MSI' mean?
These are specific genetic changes found in some bowel cancers that doctors look for. They can help predict how certain treatments might work.
What is a 'Phase II' study?
A Phase II study is one of the stages of medicine development. It mainly focuses on whether a new treatment is safe and if it shows promise in treating the disease.
Will I know which treatment I'm receiving?
This study is 'open-label', which means both you and your doctors will know which of the two treatment combinations you are receiving.
How long will I be involved in the study?
While the main observations are for the first six months, you will be monitored by the study team for up to two years or even longer, depending on your treatment progress.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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