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Study on High-Dose Vitamin C with Ipilimumab and Nivolumab for Patients with Colorectal Cancer

Verified siteRegistered drugNo placebo
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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 the effects of a combination treatment for patients with a specific type of colon cancer known as mismatch repair proficient colorectal cancer. The treatment being tested includes three components: Ipilimumab, Nivolumab, and high-dose Vitamin C. Ipilimumab and Nivolumab are medications that help the immune system fight cancer, and they are given as a solution through an infusion, which means they are delivered directly into the bloodstream. Vitamin C, commonly known as ascorbic acid, is also given in high doses through an infusion.

The purpose of this study is to see how well this combination of treatments works when given before surgery to remove the cancer. The study will involve patients receiving these treatments over a period of time before they undergo surgery. During the study, some patients may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment. The study aims to understand if this combination can improve the response of the cancer to treatment before surgery.

Participants in the study will receive the treatments in a controlled setting, and their health will be monitored closely by medical professionals. The study will help researchers learn more about the potential benefits and any side effects of using Ipilimumab, Nivolumab, and high-dose Vitamin C together in treating this type of colon cancer. This research is important for developing new ways to treat cancer and improve outcomes for patients.

The research process

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

  1. Step 1

    Initial visit and consent

    Upon joining the study, you will have an initial visit where the study team will explain the trial in detail. You will be asked to provide written informed consent to participate in the study.

    A negative serum pregnancy test is required for all women of childbearing potential within one week prior to the first study dose.

  2. Step 2

    Treatment phase

    During the treatment phase, you will receive three medications: nivolumab, ipilimumab, and high-dose ascorbic acid.

    Nivolumab and ipilimumab are administered through intravenous use, which means they are given directly into your vein. Ascorbic acid is also given as an infusion.

    The exact dosage, frequency, and duration of administration will be explained to you by the study team.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, you will have regular visits to monitor your health and the effects of the treatment. This includes assessing the pathological response rate and monitoring for any adverse events.

    You will be required to comply with all study procedures and be available for the duration of the study.

  4. Step 4

    Surgery

    If you are eligible, you will undergo surgery to remove the primary colon cancer and any liver metastasis if present.

    The timing and specifics of the surgery will be determined by your healthcare team based on your individual condition.

  5. Step 5

    End of study

    The study is expected to end by August 1, 2024. At the end of the study, you will have a final visit to assess your overall health and the outcomes of the treatment.

    You will be informed about the results of the study and any further steps if necessary.

Who can join the trial?

11 criteria

  • Must have a confirmed diagnosis of colon cancer.
  • Must be willing to avoid pregnancy during the trial. This means using effective birth control if you or your partner can have children.
  • Must not have any psychological, family, social, or geographical issues that could make it hard to follow the study rules and schedule.
  • Must be a candidate for surgery based on the stage of the cancer, as determined by medical guidelines. This includes certain stages of colon cancer and cases where the cancer has spread to the liver but can still be surgically removed.
  • Must be eligible for surgery to remove the primary colon cancer and any liver metastasis if the cancer is at a stage where it has spread to the liver.
  • Must agree to follow all study procedures and be available for the entire duration of the study.
  • Must be at least 18 years old.
  • Must provide written consent to participate in the study.
  • Must provide written consent to participate in an observational study called AlfaOmega.
  • Must have an ECOG performance status of less than 2. This is a scale used to assess how well a person can perform daily activities; a lower score means better ability.
  • Women who can have children must have a negative pregnancy test within one week before starting the study.

Who cannot join the trial?

4 criteria

  • Patients with any other type of cancer besides **colon cancer** cannot participate.
  • Patients who have a condition known as **pMMR/MSS** cannot participate. This refers to a specific genetic characteristic of the cancer.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
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Investigated drugs

  • Ipilimumab

    is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, Ipilimumab is used to help your body’s natural defenses fight colorectal cancer before surgery.

  • Nivolumab

    is another immune checkpoint inhibitor. Like Ipilimumab, it helps your immune system target and destroy cancer cells. When used together with Ipilimumab, it aims to enhance the overall immune response against colorectal cancer, making the treatment more effective.

  • Vitamin C

    is being used in high doses in this trial. While Vitamin C is commonly known as a nutrient found in foods, in this study, it is used in much larger amounts to potentially boost the effectiveness of the immune checkpoint inhibitors, Ipilimumab and Nivolumab, in fighting cancer cells before surgery.

What is already known about the treatment

  • Ipilimumab

    Ipilimumab is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently used in medicine as an immune checkpoint inhibitor, which is a type of cancer treatment. The main therapeutic indication for Ipilimumab is to help the immune system attack cancer cells, particularly in colorectal cancer. At the molecular level, it works by blocking a protein called CTLA-4, which normally helps keep immune cells in check, thereby allowing the immune system to better target and destroy cancer cells. Ipilimumab is classified as a monoclonal antibody in pharmacology.

  • Nivolumab

    Nivolumab is also administered via intravenous infusion, allowing it to enter the bloodstream directly. It is widely recognized in medical literature as an immune checkpoint inhibitor used in cancer therapy. The primary therapeutic use of Nivolumab is to treat various types of cancer, including colorectal cancer, by enhancing the body's immune response against cancer cells. It functions at the molecular level by inhibiting the PD-1 protein on immune cells, which helps the immune system recognize and attack cancer cells more effectively. Nivolumab is classified as a monoclonal antibody.

  • Vitamin C

    High-dose Vitamin C is administered intravenously, which means it is delivered directly into the bloodstream. In the context of this clinical trial, it is being explored for its potential to enhance the effects of immune checkpoint therapy in colorectal cancer. While Vitamin C is commonly known as a dietary supplement, in high doses, it is being studied for its ability to support cancer treatment by potentially improving the immune system's ability to fight cancer. Its exact mechanism in this setting is still under investigation, but it is thought to work by creating an environment that may help immune cells function more effectively. Vitamin C is classified as a vitamin and antioxidant.

Investigated diseases

Colon Cancer – Colon cancer is a type of cancer that begins in the large intestine, which is the final part of the digestive tract. It typically starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon. Over time, some of these polyps can become cancerous. As the disease progresses, cancer cells can invade and destroy normal tissue nearby and may spread to other parts of the body. The progression of colon cancer can vary, with some cases growing slowly over several years. Symptoms may not appear until the disease has advanced, making regular screenings important for early detection.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502524-41-00Estimated enrolment24 patientsSponsorASST Grande Ospedale Metropolitano Niguarda

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