Study on Pre-Surgery Immunotherapy with Relatlimab, Anti-IL-8 mAb, and Ipilimumab for Early-Stage Colon Cancer Patients

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What is this study about?

This clinical trial is focused on studying treatments for early-stage colon cancer, specifically a type called adenocarcinoma of the colon or rectosigmoid, which is considered non-rectal. The trial is exploring the use of several medications, including Relatlimab, anti-IL8 mAb (also known as BMS-986253), Yervoy (ipilimumab), Opdivo (nivolumab), and Celebrex (celecoxib). These treatments are given as solutions for infusion, which means they are administered directly into the bloodstream through a vein, except for Celebrex, which is taken orally as a capsule.

The purpose of the study is to determine the safety and feasibility of using these treatments before surgery in patients with colon cancer. The study will involve administering these medications over a period of time before the planned surgery. Participants will receive either the study medications or a placebo. The trial aims to see how well the treatments work in reducing the size of the tumor and improving the chances of a successful surgery.

Throughout the study, participants will be closely monitored to assess the effects of the treatments. This includes regular check-ups and tests to ensure the safety of the participants and to gather information on how the treatments are affecting the cancer. The study will also look at how the immune system responds to the treatments, as well as any changes in the tumor itself. The ultimate goal is to find effective treatment combinations that can improve outcomes for patients with early-stage colon cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

A CT scan is performed within 28 days prior to registration to assess the condition of the colon cancer.

2 screening tests

Screening laboratory tests are conducted within 7 days prior to registration. These tests include checks for white blood cell count, hemoglobin levels, liver function, and kidney function.

A colonoscopy is performed to obtain study-specific biopsies, which are necessary for participation.

3 treatment phase

The treatment phase involves the administration of several medications. Relatlimab, anti-IL8 mAb, Ipilimumab, and Nivolumab are given intravenously as solutions for infusion.

Additionally, Celecoxib is administered orally in the form of hard capsules.

4 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to assess the safety and feasibility of the treatment. This includes tracking the time to surgery within the predefined 6 to 8 weeks.

Follow-up assessments are performed to evaluate the response to treatment, including the major pathological response rate and complete response rate.

5 end of trial

The trial is estimated to conclude by December 3, 2024. At the end of the trial, a final assessment is conducted to determine the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

You must sign a written informed consent form, which means you agree to participate in the study after understanding all the details.
If you are a woman who can have children, you need to have a negative pregnancy test before starting the study treatment.
If you are a man who is sexually active with a woman who can have children, you must use a reliable method of birth control during the study and for 31 weeks after the last dose of the study drug.
A CT-scan (a special type of X-ray) must be done within 28 days before joining the study.
You must be at least 18 years old.
You must have a type of colon cancer called non-metastatic adenocarcinoma of the colon or rectosigmoid, which means the cancer has not spread to other parts of the body.
For certain groups in the study, the cancer must be at a specific stage, indicated as >cT3 and/or N+.
A colonoscopy (a test to look inside the colon) must be done after you agree to participate, to take specific tissue samples for the study. If this is not possible, you cannot join the study.
You must have a WHO performance status of 0 or 1, which means you are fully active or have some symptoms but can still do light work.
Blood tests must show certain levels, including white blood cells, platelets, and hemoglobin, and liver function tests must be within specific limits. These tests should be done within 7 days before joining the study.
Your creatinine clearance (a measure of kidney function) must be more than 40 ml/min.
If you are a woman who can have children, you must use a suitable method of birth control during the study and for 23 weeks after the last dose of the study drug.

Who Cannot Join the Study?

Patients with a type of cancer called adenocarcinoma of the colon or rectosigmoid, which is not considered rectal cancer, cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who belong to certain clinical trial groups that are not included in this study cannot participate.
Both male and female patients are eligible, so gender is not an exclusion factor.
Patients who are considered part of a vulnerable population are not excluded from this study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Stichting OLVG	Amsterdam	The Netherlands

Other Sites

Site Name	City	Country
Haga Hospital	Hague	The Netherlands
Tergooiziekenhuizen	Hilversum	The Netherlands
Flevoziekenhuis Stichting	Almere	The Netherlands
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
Netherlands Cancer Institute	Amsterdam	The Netherlands
Spaarne Gasthuis	Hoofddorp	The Netherlands
Dijklander Ziekenhuis	Hoorn	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	20.01.2017

Trial locations

Investigated drugs:

Immune Checkpoint Inhibitors are medications used to help the immune system recognize and attack cancer cells. In this trial, they are given before surgery to see if they can shrink the tumor or make it easier to remove. These drugs work by blocking certain proteins that prevent the immune system from attacking cancer cells.

Novel IO Combinations refer to new combinations of immunotherapy drugs being tested in this trial. These combinations aim to enhance the body’s immune response against colon cancer. The goal is to find out if these new combinations are safe and effective when given before surgery.

Investigated diseases:

Colon cancer

Adenocarcinoma of the Colon or Rectosigmoid (considered as non-rectal) – This is a type of cancer that begins in the glandular cells lining the colon or rectosigmoid area, which is the junction between the colon and rectum. It typically starts as a small growth called a polyp, which can become cancerous over time. As the disease progresses, the cancer cells can invade deeper layers of the colon wall and potentially spread to nearby lymph nodes and other organs. Symptoms may include changes in bowel habits, blood in the stool, abdominal pain, and unexplained weight loss. The progression of the disease can vary, with some cases remaining localized while others may spread to distant parts of the body. Early detection and monitoring are crucial for managing the disease effectively.

Trial ID:

2024-513314-35-00

Protocol code:

N16NCI

NCT ID:

NCT03026140

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Pre-Surgery Immunotherapy with Relatlimab, Anti-IL-8 mAb, and Ipilimumab for Early-Stage Colon Cancer Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?