iRECIST Evaluation's Relevance for DCR in MMR/MSI Metastatic Colorectal Cancer Patients on Nivolumab and Ipilimumab
This study aims to understand how effective a combination of two medicines, nivolumab and ipilimumab, is for people in the UK with advanced bowel cancer that has spread. Specifically, it's for those whose cancer has a certain genetic feature (called 'dMMR'). We're trying to improve how doctors measure if these treatments are working, particularly when looking at scans. Current methods for looking at scan results might not be the best for these new immunotherapy drugs. By identifying more accurate ways to assess scan results, doctors can make better decisions about treatment for patients, helping to ensure they receive the most suitable care.
At a glance
What is this study about?
This study is looking at a type of bowel (colorectal) cancer that has spread to other parts of the body. Doctors call this 'metastatic' cancer. We are especially interested in cancer that has a specific genetic feature, often called 'dMMR'. This feature can make the cancer more likely to respond to certain treatments, like the ones used in this study.
The study involves two medicines, nivolumab and ipilimumab. These are a type of treatment called immunotherapy, which helps your body's own immune system fight the cancer. We already know that this combination of drugs has shown promising results in some patients with this type of bowel cancer, helping to shrink tumours or stop them from growing for a long time.
One of the main goals of this study is to find the best way to measure how well these treatments are working using scans. The usual ways of measuring if a tumour is shrinking after treatment might not be as good for immunotherapy as they are for older types of cancer treatment like chemotherapy. By finding better ways to read scans, doctors can get a clearer picture of whether the treatment is effective, which will help them make the best decisions for each patient's care.
Key takeaways
- This study is for advanced bowel cancer with a specific genetic feature (dMMR).
- It uses two immunotherapy drugs, nivolumab and ipilimumab.
- A main goal is to find better ways to measure treatment success using scans.
- Participation involves regular treatments, blood tests, scans, and possibly biopsies.
- All participants need to use effective birth control during and after the study.
- You can leave the study at any time without affecting your normal care.
Who may be eligible?
To join this study, you must be an adult with bowel cancer that has spread, and your cancer must have been confirmed by tests to have a specific genetic feature (dMMR). You should be generally well enough to manage the visits and tests involved in the study.
All participants must agree to use reliable birth control during and for several months after the study treatment. This applies to both men and women. Women who could become pregnant will also need to have a negative pregnancy test before starting the treatment.
It's important that you understand what the study involves and are happy to sign a consent form, which means you agree to take part.
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 an adult aged 18 or over?
- Do you have bowel cancer that has spread to other parts of your body?
- Has your cancer been tested and confirmed to have the 'dMMR' genetic feature?
- Are you able and willing to attend regular hospital visits for treatment and tests?
- Are you (and your partner, if applicable) willing to use effective birth control for the required period?
What does participation involve?
If you join this study, you will receive two medicines, nivolumab and ipilimumab, given as injections. The study isn't comparing these drugs to other treatments; everyone in the study will receive them. You will have regular visits to the hospital for these treatments, and to have various tests, such as blood tests and scans, to check how you are doing and how the treatment is affecting your cancer. Doctors will also need to take small samples of your tumour, called biopsies, at certain times.
The main aim is to see how well the treatment is controlling your disease 12 weeks after you start. Your medical team will explain the full schedule of visits, treatments, and tests, including details about how long you'll need to use birth control after your last dose of medication. You'll have close follow-up throughout the study.
Potential risks and benefits
Locations (8)
- Institut Sainte CatherineVerified postcodeAvignon, France
- CHRU BesançonVerified postcodeBesançon, France
- Henri Mondor HospitalVerified postcodeCréteil, France
- IHFBVerified postcodeLevallois-Perret, France
- Centre Leon BerardVerified postcodeLyon, France
- CHU Nantes - Hôtel DieuVerified postcodeNantes, France
- Hospital Saint AntoineVerified postcodeParis, France
- CHU PoitiersVerified postcodePoitiers, France
Common questions
What is 'metastatic colorectal cancer'?
It means bowel cancer that has spread from where it started in the bowel to other parts of the body.
What does 'dMMR' mean?
It's a specific genetic feature of some cancer cells that can make them more likely to respond to certain treatments, like immunotherapy.
What are nivolumab and ipilimumab?
They are medicines that help your body's immune system fight cancer. They are given as injections.
What does 'RECIST' mean?
It's a standard way doctors use to measure how much a tumour is shrinking or growing on scans to see if a treatment is working.
Will I get to choose my treatment?
No, everyone in this study will receive the combination of nivolumab and ipilimumab. It's not designed to compare different treatments.
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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