Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations, in Recurrent and Metastatic Microsatellite Instability High (MSI-H) and non-MSI-H Colon Cancer

This study is testing different combinations of immunotherapies for people with bowel cancer that has either come back or spread to other parts of the body. These treatments, which include drugs like Nivolumab (Opdivo) and Ipilimumab, work by helping your body's immune system fight cancer cells. Researchers want to find out how many people respond to these new drug combinations, meaning their tumours shrink or stop growing. The study includes people with different types of bowel cancer, identified by a test called MSI status. It's a 'Phase 2' study, which means it's an important step in seeing if these treatments are effective and safe enough for further testing.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Bristol Myers Squibb International Corporation

Enrolment target

143

Start

01 Oct 2024

MSI Negative Colorectal Cancer MSI Positive Colorectal Cancer

What is this study about?

This study is looking at new ways to treat bowel cancer that has either returned after initial treatment or has spread to other parts of the body. When cancer spreads, it's called 'metastatic'. For some people, current treatments might not be working as well as hoped, so doctors are always looking for better options.

The main idea behind this study is to use special drugs called immunotherapies. These aren't like traditional chemotherapy. Instead, they work by 'waking up' your body's own immune system, helping it recognise and attack cancer cells more effectively. The study is testing different combinations of these powerful drugs, including Nivolumab (also known as Opdivo), Ipilimumab, Darzalex, and Relatlimab.

Researchers want to see if these new treatment combinations can shrink tumours or stop them from growing in people with advanced bowel cancer. They will be looking closely at how many people respond positively to the treatment, comparing different combinations in people with and without a specific genetic marker in their cancer called 'MSI-High'. This information helps doctors understand which treatments might work best for different types of bowel cancer.

Key takeaways

This study evaluates new immunotherapy combinations for advanced bowel cancer.
It aims to find out how well these new drug combinations shrink tumours.
The treatments boost your body's own immune system to fight cancer.
It's for people whose bowel cancer has returned or spread.
Participation involves receiving treatment and regular check-ups.

Who may be eligible?

To join this study, you would need to be an adult, 18 years or older, as the study is not designed for children.

Both men and women are welcome to take part in this research.

The study is specifically for people who have bowel cancer that has either come back after previous treatment or has spread to other parts of the body. Your doctor would also check certain details about your health and the characteristics of your cancer to make sure the study treatment is suitable and safe for you.

Quick self-check

Are you 18 years old or older?
Do you have bowel cancer that has come back or spread?
Are you able to attend regular clinic visits for treatment and tests?
Have you discussed your overall health with your doctor regarding suitability for a study like this?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would receive one of the study drug combinations, given through a drip into your arm (an infusion). You would have regular visits to the clinic for these treatments, as well as for check-ups and tests. These tests might include blood tests, scans (like CT scans or MRI scans) to see how your tumours are responding, and physical examinations. The doctors and nurses would monitor you closely to see how you are reacting to the treatment and to manage any side effects. The total length of your participation would depend on how you respond to the treatment and what the study doctors advise, but generally, studies like this involve regular follow-up for a period of time, even after treatment stops.

Potential risks and benefits

Taking part in a study like this might offer the chance to try new treatments that are not yet widely available, and these could potentially help shrink your cancer or slow its growth. However, there are also potential risks, as these are powerful medicines. You might experience side effects, and some could be serious, although the study team will monitor you closely and manage any side effects as best they can. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

—
Belgium
—
Italy

Common questions

What does 'MSI-High' mean?

MSI-High (Microsatellite Instability High) is a feature found in some cancer cells that can tell doctors how your cancer might respond to certain treatments, especially immunotherapies.

Are these drugs chemotherapy?

No, these drugs are immunotherapies. They work by boosting your body's own immune system to fight cancer, rather than by directly killing cancer cells like traditional chemotherapy.

Will I definitely get one of the new drugs?

Yes, in this study, all participants will receive one of the study drug combinations, which include these new immunotherapies.

How long will the treatment last?

The length of treatment varies for each person. It depends on how your body responds to the medication and what the study doctors decide is best for you.

Can I still have my regular doctor?

Yes, your regular doctors will still be involved in your care and will work closely with the study team.