Pre-operative Nivolumab and Ipilimumab, Followed by Post-operative Nivolumab, for MSI/dMMR Oeso-gastric Adenocarcinoma.
This study is looking at a new treatment approach for localised cancer in the gullet (oesophagus) or stomach (gastric) that has a specific genetic marker (MSI or dMMR). We're testing two immunotherapy drugs, nivolumab and ipilimumab, given before surgery. The main aim is to see how much the cancer shrinks or disappears after this treatment before the operation takes place. Current standard treatments don't work as well for this specific type of cancer, so we hope this new combination could offer a better way to treat it. The study is in its early stages (Phase 2), meaning we're still gathering information on its effectiveness.
At a glance
What is this study about?
This study is about a type of cancer that affects the gullet (oesophagus) or stomach. When this cancer is found early and hasn't spread, surgery is usually the best way to try and cure it. However, even with surgery and other treatments, this kind of cancer can be very challenging to treat, and unfortunately, many people don't fully recover in the long term.
We've learned that some of these gullet and stomach cancers have a special feature called 'MSI' or 'dMMR'. This feature means that the cancer cells have trouble fixing their DNA properly. While this might sound like a bad thing, it actually means these cancers often respond well to a special type of medicine called immunotherapy. Immunotherapy drugs work by helping your own body's immune system recognise and fight the cancer cells. For cancers with the MSI/dMMR feature, standard chemotherapy treatments, which are often used, don't seem to be very effective and might even cause more harm than good.
Because of this, we're testing a combination of two immunotherapy drugs, nivolumab and ipilimumab. These drugs have shown promising results in treating other cancers with the MSI/dMMR feature. In this study, people will receive these immunotherapy drugs *before* their surgery. The main thing we want to find out is how well this combination treatment can shrink or even completely get rid of the cancer before the operation. This is called the 'complete pathological response rate'. If it works well, it could lead to better outcomes for people with this specific type of gullet or stomach cancer.
Key takeaways
- The study tests immunotherapy (nivolumab and ipilimumab) before surgery for specific stomach/gullet cancers.
- It's for cancers with the 'MSI' or 'dMMR' genetic feature, which respond well to immunotherapy.
- Standard chemotherapy isn't very effective for this type of cancer.
- The main goal is to see if the drugs shrink the cancer significantly before surgery.
- This is a Phase 2 study, gathering information on effectiveness.
- Participation involves regular hospital visits, treatments, and tests.
Who may be eligible?
To be considered for this study, you would generally need to be an adult between 18 and 75 years old. You must have stomach or gullet cancer that hasn't spread to other parts of your body, and importantly, your cancer must have the special 'MSI' or 'dMMR' feature. This feature will be checked by special tests on your cancer cells.
Your general health needs to be good enough to take part, meaning your blood tests, kidney, and liver function should be within certain limits. You shouldn't have had any other treatment for your cancer yet. You also need to be able to come for regular appointments, tests, and scans as part of the study.
Women who could become pregnant will need to have a negative pregnancy test before starting the study drugs. The study is open to both men and women.
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 between 18 and 75 years old?
- Do you have stomach or gullet cancer that hasn't spread?
- Has your cancer been tested and confirmed to have the 'MSI' or 'dMMR' feature?
- Have you *not* had any previous treatment for this specific cancer?
- Are you generally well enough for regular hospital visits and treatments (doctors will check this)?
What does participation involve?
If you join this study, you will receive treatment with two drugs, nivolumab and ipilimumab, over a period before your surgery. You will have regular hospital visits for these treatments and to monitor your health. This will involve blood tests, physical examinations, and imaging scans (like CT scans) to see how the treatment is working. We will also need to take small samples of your cancer (biopsies) at certain times to learn more about how the drugs affect the cancer cells.
After your initial treatment course and surgery, you will continue with follow-up visits to check on your recovery and health. The total duration of your involvement in the study will be discussed with you, but it will include the treatment period, surgery, and a period of follow-up to track your progress over time.
Potential risks and benefits
Locations (15)
- CHRU Jean MinjozVerified postcodeBesançon, France
- Hôpital Henri MondorVerified postcodeCréteil, France
- Institut Hospitalier Franco-BritanniqueVerified postcodeLevallois-Perret, France
- CHRU LilleVerified postcodeLille, France
- Centre Léon BérardVerified postcodeLyon, France
- Hôpital Privé Jean MermozVerified postcodeLyon, France
- ICM Val d'AurelleVerified postcodeMontpellier, France
- CHU NantesVerified postcodeNantes, France
- Hôpital Européen Geroges PompidouVerified postcodeParis, France
- Hôpital Saint AntoineVerified postcodeParis, France
- Hôpital Saint LouisVerified postcodeParis, France
- Institut Mutualiste MontsourisVerified postcodeParis, France
Common questions
What does 'MSI' or 'dMMR' mean?
These are genetic features of your cancer cells that mean they might respond better to immunotherapy than to standard chemotherapy.
Are nivolumab and ipilimumab chemotherapy drugs?
No, they are immunotherapy drugs. They work by boosting your body's own immune system to fight the cancer, rather than by directly killing cancer cells like chemotherapy.
Will I still need surgery if I participate in this study?
Yes, surgery is still planned as the main treatment for your cancer in this study. The immunotherapy is given beforehand to try and make the surgery more effective.
What phase is this study in?
This is a Phase 2 study, which means we are still in the earlier stages of investigating this treatment. We are primarily looking at how effective it is.
Will I know if I'm getting the study drugs?
Yes, this is an 'open label' study, meaning you and your doctors will know that you are receiving nivolumab and ipilimumab.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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