Study of Nivolumab, Ipilimumab, Relatlimab, and Daratumumab in Patients with Recurrent and Metastatic Colon Cancer

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What is this study about?

This clinical trial is focused on studying treatments for colon cancer, specifically in cases where the cancer has returned or spread to other parts of the body. The study is investigating the effectiveness of a medication called Nivolumab, which may be used alone or in combination with other medications. These combinations include Nivolumab with Ipilimumab, Nivolumab with an anti-LAG3 agent known as Relatlimab, and Nivolumab with Daratumumab. The purpose of the study is to see if these treatments can produce a significant response in patients with a specific marker in their tumors.

The study involves patients with two types of colorectal cancer: those with MSI Positive Colorectal Cancer and those with MSI Negative Colorectal Cancer. MSI stands for microsatellite instability, which is a condition of genetic hypermutability that results from impaired DNA mismatch repair. The trial aims to determine the objective response rate, which is a measure of how well the cancer responds to the treatment, in both types of patients.

Participants in the study will receive the treatments through intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will monitor the response of the cancer to these treatments over time. The trial is designed to provide valuable information on the potential benefits of these treatment combinations for patients with recurrent and metastatic colon cancer.

1 enrollment

Upon joining the study, eligibility is confirmed based on specific criteria such as age, performance status, and confirmed colorectal cancer diagnosis.

Participants must have measurable disease and undergo testing for microsatellite instability (MSI) status.

Consent is required, and participants must agree to comply with study procedures and use birth control as specified.

2 treatment initiation

Treatment begins with the administration of nivolumab alone or in combination with other medications.

The medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

3 nivolumab administration

Nivolumab is administered as a 10 mg/mL concentrate for solution for infusion.

The frequency and duration of administration depend on the specific treatment plan assigned to the participant.

4 combination therapy

Participants may receive nivolumab in combination with other medications such as ipilimumab, daratumumab, or relatlimab.

Each combination is designed to target specific aspects of the cancer and is administered intravenously.

5 monitoring and assessment

Throughout the trial, participants undergo regular monitoring to assess the response to treatment.

This includes imaging tests like CT or MRI to measure changes in the disease.

6 completion and follow-up

The trial is expected to continue until September 2024, with follow-up assessments to evaluate long-term outcomes.

Participants are monitored for any side effects and overall health status after completing the treatment phase.

Who Can Join the Study?

Men and women who are 18 years or older can participate.
Participants must have an ECOG performance status of 0 to 1, which means they should be fully active or have some symptoms but can still do light work.
Participants must have colorectal cancer confirmed by a tissue sample test.
The disease must be measurable using a CT or MRI scan.
Participants need to have their MSI status tested. This refers to a specific characteristic of the cancer cells. Depending on the results, they will be placed in different groups within the study.
Participants must have adequate organ function, which will be checked through specific lab tests.
Participants must use an acceptable form of birth control during the study. Women who can have children should continue using birth control for 23 weeks after the last dose of the study drug, and men should do so for 31 weeks if they are sexually active with women who can have children.
Participants must provide signed informed consent, which means they agree to participate after understanding the study details.
Participants must be willing and able to follow the study procedures. Those in the C3 Cohort should not have received treatment for their metastatic disease.

Who Cannot Join the Study?

Patients who have had another type of cancer in the past, except for certain skin cancers that have been treated.
Patients who have an active infection that requires treatment with antibiotics, antivirals, or antifungals.
Patients who have a history of severe allergic reactions to any of the drugs used in the study.
Patients who are pregnant or breastfeeding.
Patients who have an autoimmune disease, which is when the body’s immune system attacks its own healthy cells.
Patients who have received a live vaccine within 30 days before starting the study treatment.
Patients who have a condition that affects the brain or nerves, such as seizures or a history of stroke.
Patients who have uncontrolled heart problems, like heart failure or a recent heart attack.
Patients who have a history of drug or alcohol abuse that could interfere with their ability to participate in the study.
Patients who are taking medications that suppress the immune system, which are drugs that lower the body’s ability to fight infections and other diseases.

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
Istituto Oncologico Veneto	Padua	Italy
Institut Jules Bordet	Anderlecht	Belgium
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	25.03.2014
Italy	Not recruiting	25.03.2014

Trial locations

Investigated drugs:

Nivolumab is a medication used in this trial to help the body’s immune system fight cancer cells. It works by blocking a protein that prevents the immune system from attacking cancer cells, allowing the immune system to better target and destroy them.

Ipilimumab is used in combination with Nivolumab in this trial. It also helps the immune system attack cancer cells by blocking a different protein that can stop the immune system from working effectively against cancer.

BMS-986016 is an experimental medication used in combination with Nivolumab. It targets a specific protein involved in regulating the immune system, potentially enhancing the ability of the immune system to fight cancer.

Daratumumab is another medication used in combination with Nivolumab in this trial. It is an antibody that targets a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells.

Investigated diseases:

Colorectal cancer

MSI Negative Colorectal Cancer – This type of colorectal cancer is characterized by the absence of microsatellite instability, meaning the DNA mismatch repair system is functioning normally. It typically progresses through the accumulation of genetic mutations that lead to uncontrolled cell growth in the colon or rectum. The disease can spread to nearby tissues and organs, and in advanced stages, it may metastasize to distant parts of the body. Patients may experience symptoms such as changes in bowel habits, abdominal pain, and weight loss as the disease progresses.

MSI Positive Colorectal Cancer – This form of colorectal cancer is marked by the presence of microsatellite instability, indicating a defect in the DNA mismatch repair system. It often progresses more slowly than MSI negative types and may respond differently to certain treatments. The cancerous cells can grow and invade surrounding tissues, potentially spreading to other areas of the body. Symptoms may include rectal bleeding, persistent abdominal discomfort, and fatigue as the disease advances.

Trial ID:

2024-516004-42-01

Protocol code:

CA209-142

NCT ID:

NCT02060188

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Nivolumab, Ipilimumab, Relatlimab, and Daratumumab in Patients with Recurrent and Metastatic Colon Cancer

What is this study about?

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