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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Seconda Universita Di Napoli	Naples	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.04.2023

Trial locations

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.

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 ID:

2022-502524-41-00

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?