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Active not recruitingPHASE3INTERVENTIONAL

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

This research study is for people with advanced bowel cancer (colorectal cancer) that has spread to other parts of the body. Doctors are investigating different treatments for a specific type of this cancer, called dMMR or MSI-H, which means the cancer cells have certain genetic differences. The study compares treatment with nivolumab on its own, nivolumab combined with another drug called ipilimumab, and standard chemotherapy. Researchers want to find out which treatment helps patients live longer, stops the cancer from growing for longer, and shrinks the cancer more effectively. This could lead to better treatments for this particular type of bowel cancer.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Bristol-Myers Squibb
Enrolment target
839
Start
05 Aug 2019
Estimated completion
10 Jun 2026

What is this study about?

This study is for people in the UK who have bowel cancer (colorectal cancer) that has spread to other parts of the body, which doctors call metastatic colorectal cancer. Specifically, it focuses on a type of cancer that has a certain genetic feature called 'dMMR' or 'MSI-H'. These letters stand for 'deficient mismatch repair' and 'microsatellite instability-high', and they mean the cancer cells have trouble fixing mistakes in their DNA.

In this study, doctors are comparing a few treatment options. One is a drug called nivolumab, given on its own. Another option is nivolumab combined with another drug called ipilimumab. These drugs are a type of treatment called immunotherapy, which helps your body's own immune system fight the cancer. The study also compares these newer treatments with standard chemotherapy, which is a common way to treat cancer.

The main goal is to see which treatment works best. They will look at how long people live, how long it takes for the cancer to start growing again, and whether the cancer shrinks. Finding better treatments for dMMR/MSI-H metastatic colorectal cancer could significantly improve outcomes for patients.

Key takeaways

  • Study for advanced bowel cancer (metastatic colorectal cancer).
  • Focuses on a specific type of cancer: dMMR/MSI-H.
  • Compares new immune-boosting drugs (nivolumab and ipilimumab) with standard chemotherapy.
  • Aims to find better treatments to control cancer and improve patient lives.
  • Participation involves regular check-ups and receiving study treatments.
  • You can discuss with your doctor if this study might be suitable for you.

Who may be eligible?

To join this study, you would need to have bowel cancer that has spread to other parts of your body. Your doctor would need to confirm that your cancer has the specific dMMR or MSI-H features. You can't have had previous chemotherapy or targeted treatments for your widespread cancer if you are joining a specific part of the study, but for an earlier part, previous treatments might be okay.

There are also some reasons why you might not be able to join. For example, if you have certain autoimmune conditions (where your body's immune system attacks itself), specific lung problems, or if you have HIV/AIDS. Your general health would also be assessed to make sure you are well enough 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.

  1. Do you have bowel cancer that has spread?
  2. Has your doctor confirmed your cancer has 'dMMR' or 'MSI-H' features?
  3. Are you 18 years old or older?
  4. Are you generally well enough to take part in a study?
  5. Do you have any conditions like autoimmune disease or specific lung problems?
Answer every question to see your result.

What does participation involve?

The detailed plan for taking part isn't fully explained here, but generally, participating in a study like this involves regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working. You would receive one of the study drugs or a combination of drugs. The total duration of the study, including how long you would receive treatment and how long you would be followed up afterwards, would be clearly explained by the study team. They would also detail how often you need to attend the clinic and what medical assessments you would undergo.

Potential risks and benefits

Taking part in a clinical trial offers the chance to receive new treatments that might be more effective than standard care. However, new treatments can have side effects, and it's possible that the new treatments may not work for everyone. Standard chemotherapy also has known side effects, which would be explained to you. All possible risks and benefits will be fully discussed by the study team, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (157)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Local Institution - 0059
    Verified postcode
    Los Angeles, United States
  • Local Institution - 0130
    Verified postcode
    Sacramento, United States
  • Local Institution - 0103
    Verified postcode
    Denver, United States
  • Local Institution - 0119
    Verified postcode
    Arlington Heights, United States
  • Local Institution - 0060
    Verified postcode
    New York, United States
  • Local Institution - 0105
    Verified postcode
    Portland, United States
  • Local Institution - 0121
    Verified postcode
    Pittsburgh, United States
  • Local Institution - 0106
    Verified postcode
    Dallas, United States
  • Local Institution - 0104
    Verified postcode
    Roanoke, United States
  • Local Institution - 0073
    Unverified
    Ciudad Autonoma Beunos Aires, Argentina
  • Local Institution - 0074
    Verified postcode
    Viedma, Argentina
  • Local Institution - 0084
    Verified postcode
    Buenos Aires, Argentina

Common questions

What does 'metastatic colorectal cancer' mean?

It means bowel cancer that has spread from where it started to other parts of your body.

What are 'dMMR' and 'MSI-H'?

These are special features found in some cancer cells. They tell doctors that the cancer might respond differently to certain treatments, like the new drugs in this study.

What is immunotherapy?

Immunotherapy is a type of treatment that helps your body's own immune system find and fight cancer cells.

Will I definitely get the new drugs?

The study compares different treatments, including new drugs and standard chemotherapy. You will be assigned to one of the treatment groups.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time, and this will not affect your future medical care.

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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