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Study of ipilimumab, nivolumab, temozolomide and capecitabine in patients with chemotherapy-resistant metastatic colorectal cancer with specific genetic markers

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What is this study about?

This study focuses on treating metastatic colorectal cancer that has not responded to previous chemotherapy treatments. The research combines several medications: ipilimumab and nivolumab (which are given through an intravenous infusion and help the immune system fight cancer cells), along with temozolomide and capecitabine (which are taken as oral medications that work to stop cancer cells from growing).

The purpose of this research is to test whether immunotherapy treatment, which usually works only for a small number of colorectal cancer patients, could be made effective for more patients when combined with other medications. The study will also look for biological markers that might help predict which patients will respond best to this treatment.

During the study, which may last up to 24 months, participants will receive a combination of these medications. The treatment involves taking temozolomide and capecitabine tablets daily, while ipilimumab and nivolumab are given through an intravenous infusion at scheduled times. Throughout the treatment, doctors will monitor how the cancer responds to these medications through regular medical check-ups and imaging tests.

1 Initial Treatment Phase

You will begin treatment with temozolomide and capecitabine, which are taken as oral medications

Your response to this treatment will be evaluated through a CT scan after 16 weeks

2 Treatment Continuation

Based on your response to the initial treatment, you may continue with the same medications

If needed, additional medications may be introduced: ipilimumab and nivolumab, which are given through intravenous infusion

3 Regular Monitoring

Your health status will be regularly monitored through blood tests to check bone marrow and organ function

Doctors will track several health indicators including:

– Neutrophil count (type of white blood cells)

– Platelet levels

– Liver function

– Kidney function

4 Response Assessment

Your response to treatment will be evaluated using CT scans

The medical team will assess if the cancer is stable, shrinking, or growing

You will complete quality of life questionnaires during the study

5 Long-term Follow-up

The study continues until September 2029

Regular assessments will track how long the treatment remains effective

Your overall survival and quality of life will be monitored throughout the study period

Who Can Join the Study?

  • You must sign a written informed consent form
  • You must be at least 18 years old
  • You must have metastatic or non-resectable colorectal cancer (cancer that has spread or cannot be removed by surgery)
  • Your tumor must have specific genetic characteristics confirmed by laboratory tests (MSS or pMMR)
  • Your tumor must have a specific genetic marker called MGMT promoter methylation, confirmed by laboratory tests
  • You must have received previous treatment with oxaliplatin, irinotecan and fluoropyrimidine-based chemotherapy (or be unable to tolerate these medications)
  • You must have good physical function, with an ECOG performance status of 0-1 (able to perform daily activities with minimal assistance)
  • If you are a woman who can become pregnant, you must:
    • Have a negative pregnancy test within 5 days before starting the study
    • Use effective birth control during the study and for 6 months after stopping treatment
  • You must have adequate organ function, including:
    • Healthy bone marrow function (adequate blood cell counts)
    • Normal liver function tests
    • Good kidney function

Who Cannot Join the Study?

  • Prior treatment with immunotherapy (treatment that helps your immune system fight cancer)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Known hypersensitivity (severe allergic reaction) to study medications
  • Active autoimmune disease (condition where your immune system attacks healthy cells)
  • Uncontrolled heart disease or high blood pressure
  • Major surgery within 28 days before starting the study
  • Active infection requiring systemic treatment (medication that affects your whole body)
  • HIV, hepatitis B, or hepatitis C infection
  • Other active cancers requiring treatment (except for certain skin cancers)
  • Pregnancy or breastfeeding
  • Any medical condition that could interfere with study procedures or safety
  • Participation in another clinical trial within 30 days
  • Unable to give informed consent (permission to participate)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Odense University Hospital Odense Denmark
Aalborg University Hospital Aalborg Denmark
Rigshospitalet Copenhagen Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not yet recruiting
01.06.2026

Trial locations

Investigated drugs:

Ipilimumab is an immunotherapy medication that helps the body’s immune system fight cancer cells. It works by blocking a protein that prevents T-cells (immune cells) from attacking cancer cells, allowing the immune system to work more effectively against the disease.

Nivolumab is also an immunotherapy medication that works with the immune system. It blocks a different protein that cancer cells use to avoid being detected by the immune system. When this protein is blocked, the immune system can better recognize and attack cancer cells.

Temozolomide is a chemotherapy medication that works by stopping cancer cells from making new DNA, which they need to multiply and grow. It belongs to a group of drugs called alkylating agents.

Capecitabine is an oral chemotherapy medication that converts to fluorouracil in the body. It interferes with cancer cell growth by blocking the formation of new DNA in cancer cells, which prevents them from multiplying.

Investigated diseases:

Colorectal cancer – A disease that begins when cells in the colon or rectum start to grow out of control. It typically starts as a growth called a polyp on the inner lining of the colon or rectum. Over time, some polyps can develop into cancer. The cancer can grow through the wall of the colon or rectum and spread to other parts of the body. The disease usually develops slowly over several years. When it spreads beyond its original location, it’s called metastatic colorectal cancer (mCRC). The disease affects the digestive system’s ability to function properly and can cause changes in bowel habits.

Trial ID:
2025-521941-25-00
Trial Phase:
Therapeutic exploratory (Phase II)

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