Recruiting

Study on Immunotherapy with Nivolumab and Ipilimumab for Patients with Early Stage dMMR Rectal Cancer

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What is this trial about?

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

This clinical trial is focused on studying a type of cancer known as rectal cancer, specifically in its early stages. The study is investigating the effects of two medications, nivolumab and ipilimumab, which are used in a treatment approach called immunotherapy. Immunotherapy is a method that helps the body's immune system fight cancer. The trial is particularly interested in patients with a specific characteristic of rectal cancer called dMMR (deficient mismatch repair), which is a condition where the cancer cells have trouble repairing their DNA.

The purpose of this study is to evaluate how effective and tolerable the combination of nivolumab and ipilimumab is for patients with stage 1 to 3 MSI (microsatellite instability) or dMMR rectal cancer. Participants in the study will receive these medications through an intravenous infusion, which means the medicine is given directly into a vein. The study will observe patients over a period of time to see how well the cancer responds to the treatment and to monitor any side effects. The trial will also look at how many patients show no signs of cancer after 12 months and assess their quality of life during and after the treatment.

Throughout the study, researchers will use various methods to evaluate the response to treatment, including physical examinations, endoscopy, and MR (magnetic resonance) scans. The study aims to determine the number of patients who achieve a complete response, meaning no visible or palpable tumor remains. Additionally, the study will explore the relationship between certain biological markers and the outcomes of the treatment. The trial is expected to continue until November 2027, providing valuable insights into the potential benefits of immunotherapy for early-stage rectal cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be required to provide written informed consent. This is a document that confirms your understanding of the trial and your agreement to participate.
You must meet certain criteria, such as being 18 years or older, having a specific type of rectal cancer, and having adequate organ function.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your health status. This may include blood tests to check your blood cell counts and organ function.
A pregnancy test will be required for women of childbearing potential to ensure safety during the trial.
Step 3
Treatment cycle 1
You will receive two medications: nivolumab and ipilimumab. These are given as solutions through an intravenous infusion, which means they are administered directly into your bloodstream through a vein.
The dosage and frequency of these medications will be determined by the trial protocol, and you will be monitored closely for any side effects.
Step 4
Evaluation after cycle 1
After the first cycle of treatment, your response to the medication will be evaluated. This may involve physical examinations, endoscopy, and MR scans to check for any changes in the tumor.
The goal is to determine if there is a complete clinical response, meaning no visible or palpable tumor.
Step 5
Treatment cycle 2
If necessary, a second cycle of treatment with nivolumab and ipilimumab will be administered. The process will be similar to the first cycle.
You will continue to be monitored for any side effects and changes in your condition.
Step 6
Final evaluation
A final evaluation will be conducted approximately 93 days after starting the treatment. This will include various tests to assess the effectiveness of the treatment.
The primary focus will be on determining if there is a complete clinical response, as well as checking for any biological response and signs of recurrence.
Step 7
Follow-up
You will be monitored for up to 12 months to check for any signs of cancer recurrence and to assess your overall quality of life.
Regular follow-up visits will be scheduled to ensure your continued health and to gather data for the trial.

Who can join the trial?

10 criteria

Must be 18 years or older.
Must provide written informed consent before any study procedures. This means you agree to participate after being informed about the study.
Must have rectal cancer that is confirmed by a test called a histology test, and it should be in stage 1 to 3, which means it has not spread to other parts of the body.
Should not need local treatments like TEM (a type of surgery).
Must have a specific type of cancer called dMMR or MSI, which are specific characteristics of the cancer cells.
Must have a performance status of 0-1 according to the WHO scale, which means you are fully active or have some symptoms but can carry out light work.
Must not have had any previous treatments like chemotherapy, radiotherapy, or immunotherapy for colorectal cancer.
Must have adequate blood function, meaning enough white blood cells (neutrophils ≥ 1.5 x 10⁹/l) and platelets (≥ 100 x 10⁹/l).
Must have adequate organ function, meaning normal levels of bilirubin (≤ 1.5 times the upper normal limit) and a kidney function test (GFR) greater than 30 ml/min.
Women who can have children must have a negative pregnancy test within five days before joining the study and must agree to use a highly effective method of birth control during the study and for six months after stopping the study medication.

Who cannot join the trial?

10 criteria

Patients with any other type of cancer besides stage 1-3 MSI/dMMR rectal cancer cannot participate.
Patients who have previously received treatment with the drugs nivolumab or ipilimumab are not eligible.
Patients with a history of severe allergic reactions to any of the study drugs cannot join the trial.
Patients with active infections that require treatment with antibiotics, antivirals, or antifungals are excluded.
Patients with autoimmune diseases, which are conditions where the immune system attacks the body, are not eligible.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients with significant heart problems, such as heart failure or recent heart attacks, are excluded.
Patients with uncontrolled high blood pressure are not eligible.
Patients with severe liver or kidney disease cannot join the trial.
Patients who have participated in another clinical trial within the last 30 days are excluded.

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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

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Investigated drugs

Nivolumab
is a type of immunotherapy that helps your immune system fight cancer. It works by blocking a protein on cancer cells, which allows your immune system to recognize and attack these cells more effectively. This can help slow down or stop the growth of cancer.
Ipilimumab
is another immunotherapy that boosts your immune system's ability to fight cancer. It works by targeting a specific protein that usually helps keep the immune system in check. By blocking this protein, ipilimumab allows your immune system to become more active in attacking cancer cells.

What is already known about the treatment

Nivolumab
Nivolumab is administered as an intravenous infusion, meaning it is given directly into a vein through a drip. It is currently being studied in clinical trials for its effectiveness in treating certain types of cancer, specifically early-stage rectal cancer with specific genetic characteristics. Nivolumab works by helping the immune system recognize and attack cancer cells more effectively. It belongs to a class of drugs known as immune checkpoint inhibitors, which help to boost the body's natural defenses against cancer.
Ipilimumab
Ipilimumab is also given as an intravenous infusion, similar to nivolumab. It is being tested in combination with nivolumab to see how well it works in treating early-stage rectal cancer with specific genetic markers. Ipilimumab enhances the immune system's ability to fight cancer by blocking a molecule that usually keeps immune responses in check. Like nivolumab, it is classified as an immune checkpoint inhibitor, which helps the immune system target and destroy cancer cells.

Investigated diseases

Rectal Cancer – Rectal cancer is a type of cancer that begins in the rectum, which is the last several inches of the large intestine before the anus. It typically starts as a growth on the inner lining of the rectum, known as a polyp, which can become cancerous over time. As the disease progresses, the cancer cells can invade deeper layers of the rectal wall and potentially spread to nearby lymph nodes and other organs. The progression of rectal cancer is categorized into stages, with stage 1 being early and stage 3 indicating more advanced disease with greater spread. Symptoms may include changes in bowel habits, rectal bleeding, and abdominal discomfort. The disease can be influenced by genetic factors, lifestyle, and environmental exposures.