AuthorisedTherapeutic exploratory (Phase II)Interventional

Ipilimumab and nivolumab plus temozolomide and capecitabine for patients with chemo-refractory pMMR, MGMT silenced metastatic colorectal cancer: The MAYA2 trial

This study, called MAYA2, is for people with bowel cancer that has spread to other parts of the body (metastatic) and hasn't improved with standard chemotherapy. It's particularly for those where a specific genetic test (pMMR, MGMT silenced) shows a certain cancer characteristic. The researchers are testing a new treatment combination: two immunotherapy drugs (ipilimumab and nivolumab) alongside two chemotherapy drugs (temozolomide and capecitabine). The main goal is to see how many people's cancer is controlled (meaning it shrinks, stays the same, or disappears) after 16 weeks of treatment. This is a Phase II study, meaning it's an early-stage trial looking at how effective and safe the new combination is.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Odense University Hospital

Enrolment target

165

Start

19 Sep 2025

Colorectal cancer

What is this study about?

This study is focusing on a type of bowel cancer (colorectal cancer) that has spread to other parts of the body and hasn't responded well to previous chemotherapy treatments. When cancer spreads, it's called metastatic. The study is also looking at specific features of the cancer cells, which are identified using special tests (pMMR and MGMT silenced). These features can sometimes tell us more about how the cancer might respond to certain treatments.

The researchers are testing a new approach by combining several existing cancer medications. Two of these, ipilimumab and nivolumab, are immunotherapy drugs. Immunotherapy works by helping your body's own immune system fight the cancer. The other two, temozolomide and capecitabine, are chemotherapy drugs which work by killing cancer cells. This study is trying to understand if giving these drugs together can be more effective than current approaches for this particular type of advanced bowel cancer.

The main aim is to see how many people's cancer is controlled after a period of treatment, meaning it either shrinks, stops growing, or disappears completely. They will check this with scans after 16 weeks. The study will also look at how long people live, how long it takes for the cancer to start growing again, the overall response to treatment, and very importantly, how safe and tolerable the new combination of drugs is. They'll also be checking how the treatment affects people's quality of life.

Key takeaways

This study is for advanced bowel cancer that hasn't responded to other treatments.
It's testing a new combination of immunotherapy and chemotherapy drugs.
The main goal is to see how well this new combination controls the cancer.
Participants will have regular scans and check-ups.
The study also looks at safety, side effects, and quality of life.

Who may be eligible?

To be considered for this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.

Crucially, you would have to have a specific type of bowel cancer that has spread, and it must be cancer that your doctors have found hasn't responded well to previous chemotherapy treatments. There are also specific genetic test results (pMMR and MGMT silenced) that your cancer cells would need to show. Your doctor would carry out these special tests to see if your cancer fits this profile.

There will also be other medical checks and criteria that your doctor will review to make sure the study is a safe and appropriate option for you. These might include your general health, other medical conditions you have, and other medications you are taking.

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 bowel cancer that has spread?
Has your bowel cancer not responded to previous chemotherapy?
Has your doctor confirmed specific genetic markers (pMMR, MGMT silenced) in your cancer?
Are you prepared for regular hospital visits and assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive a combination of medicines: ipilimumab, nivolumab, temozolomide, and capecitabine. These would be given according to a specific schedule decided by the study doctors. You would have regular appointments at the hospital for treatments, check-ups, and to monitor your health. These appointments would involve various assessments, such as blood tests and physical examinations.

A key part of the study involves having CT scans (a type of X-ray that takes detailed pictures inside your body) to check how your cancer is responding to the treatment. These scans would happen at specific times, particularly around 16 weeks after starting the main treatment. You would also be asked to complete questionnaires about your quality of life, which helps the researchers understand how the treatment is affecting your daily living.

The exact total duration of your participation would depend on how your cancer responds to the treatment and what side effects you might experience. However, even after your main treatment period, there would likely be a follow-up period where doctors continue to monitor your health and cancer status.

Potential risks and benefits

Participating in a clinical trial like this may offer potential benefits, such as access to new medications that are not yet widely available. It could also mean more frequent monitoring by experts. However, there are also potential risks involved. The drugs being tested can cause side effects, some of which might be serious. Because these drugs are being used in a new combination, the full range or severity of side effects might not be completely known. 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 future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is 'metastatic colorectal cancer'?

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

What does 'chemo-refractory' mean?

It means your cancer hasn't responded as expected to previous chemotherapy treatments.

What are 'immunotherapy' drugs?

These are medicines that help your body's own immune system fight the cancer more effectively.

What is a 'Phase II' study?

This is an early stage of research to see if a new treatment is effective and safe enough to be tested in larger groups of people.

How will they know if the treatment is working?

They will use scans, like CT scans, to see if the cancer is shrinking, staying the same, or disappearing.