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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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
Step 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 trial?

12 criteria

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 trial?

13 criteria

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)

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Aalborg University Hospital
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Aalborg, Denmark
Odense University Hospital
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Odense, Denmark
Rigshospitalet
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Copenhagen, Denmark

Trial locations

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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.

What is already known about the treatment

Ipilimumab
An intravenously administered immunotherapy medication that belongs to the class of immune checkpoint inhibitors. This monoclonal antibody works by targeting and blocking CTLA-4, a protein that helps regulate immune system responses, thereby enhancing the body's immune response against cancer cells. It is primarily used in the treatment of various cancers, including colorectal cancer, and is often combined with other immunotherapy agents to improve treatment effectiveness.
Nivolumab
An immunotherapy medication administered through intravenous infusion that functions as a PD-1 checkpoint inhibitor. This monoclonal antibody blocks the interaction between PD-1 and its ligands, helping to restore T-cell anti-tumor immune response. It is commonly used in combination therapy for various cancers, including colorectal cancer, and has shown significant efficacy in clinical trials when paired with other immunotherapy agents.
Temozolomide
An oral chemotherapy medication belonging to the alkylating agent class. This drug works by damaging the DNA of cancer cells, preventing them from dividing and growing, ultimately leading to their death. It crosses the blood-brain barrier effectively and is commonly used in combination therapy protocols for various cancers, including colorectal cancer with specific genetic profiles.
Capecitabine
An oral chemotherapy medication that belongs to the fluoropyrimidine class of drugs. This medication is converted into 5-fluorouracil (5-FU) in the body, where it interferes with DNA synthesis and stops cancer cell growth. It is commonly used in the treatment of colorectal cancer and is often prescribed as part of combination therapy protocols due to its convenient oral administration and established effectiveness.

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.