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Study of Oxaliplatin and Nivolumab for Patients with Metastatic Colorectal 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 colorectal cancer, which affects the large bowel and can spread to other organs. The study is investigating a treatment approach that combines chemotherapy and immunotherapy. The chemotherapy involves a drug called oxaliplatin, which is used to kill cancer cells, and the immunotherapy involves a drug called nivolumab, which helps the immune system fight cancer. The purpose of the study is to determine how long patients can live without the cancer getting worse when treated with this combination.

Participants in the study will receive the chemotherapy drug oxaliplatin as part of a regimen known as the Nordic FLOX regimen, along with the immune checkpoint inhibitor nivolumab. The treatment will be given in cycles, and the progress of the cancer will be monitored regularly through imaging tests. Some patients will also receive other medications to help manage side effects, such as ondansetron for nausea, dexamethasone for inflammation, and metoclopramide for stomach issues. The study will also look at the safety and tolerability of the treatment, as well as how well it works in shrinking the cancer.

The study will continue for a period of time, during which the health and response of the participants will be closely monitored. The goal is to gather information on how effective the treatment is in controlling the cancer and improving the quality of life for patients with this type of colorectal cancer. The results of this study could help improve treatment options for patients in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of colorectal cancer and ensuring that the disease has spread to other organs.
The assessment will also check that no previous systemic treatment for metastatic disease has been received, except for any prior neoadjuvant treatment.
Step 2
Treatment cycle 1: nordic flox regimen
The first treatment cycle involves the Nordic FLOX regimen, which includes the administration of oxaliplatin and fluorouracil. These medications are given through an intravenous infusion.
The cycle is repeated every two weeks, and the exact dosage and duration will be determined by the healthcare team based on individual needs.
Step 3
Treatment cycle 2: nivolumab
Following the completion of the first cycle, the next phase involves the administration of nivolumab, an immune checkpoint inhibitor. This is also given through an intravenous infusion.
This cycle is repeated every two weeks, and the healthcare team will monitor the response to treatment.
Step 4
Ongoing assessments
Throughout the trial, regular assessments will be conducted to monitor the progression of the disease. These assessments occur after every two cycles of treatment.
The assessments will include radiologic evaluations to measure the response to treatment.
Step 5
Safety and tolerability monitoring
Safety and tolerability of the treatment will be monitored continuously. Any side effects or adverse events will be recorded and evaluated at each visit.
The healthcare team will provide guidance on managing any side effects experienced during the trial.
Step 6
Completion of trial
The trial is expected to continue until March 2026, or until the disease progresses or unacceptable side effects occur.
Upon completion, a final assessment will be conducted to evaluate the overall response to the treatment.

Who can join the trial?

6 criteria

The patient must have a type of colorectal cancer called adenocarcinoma, which has been confirmed by a doctor.
The patient must have cancer that can be seen and measured using imaging tests, which means it has spread to other parts of the body.
The patient must not have received any previous strong cancer treatments (called systemic cytotoxic therapy) for cancer that has spread, except for treatments given before surgery to shrink the tumor.
The patient must be able to receive a specific type of chemotherapy treatment known as the Nordic FLOX regimen.
The patient can be of any gender, as both males and females are eligible to participate.
The patient must be within the age range that is allowed for the study.

Who cannot join the trial?

5 criteria

Patients who have had previous treatment for their colorectal cancer cannot participate.
Patients with cancer that can be surgically removed are not eligible.
Patients with a type of colorectal cancer that is not **pMMR/MSS** are excluded. pMMR/MSS refers to a specific genetic characteristic of the cancer.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Akershus University Hospital
Lorenskog, Norway
Verified
Helse Bergen HF
Bergen, Norway
Responsive
Universitetssykehuset Nord-Norge HF
Tromsø, Norway

Trial locations

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Investigated drugs

Oxaliplatin
is a type of chemotherapy drug used in this clinical trial. It works by damaging the DNA of cancer cells, which stops them from growing and dividing. In this study, oxaliplatin is part of a treatment plan aimed at controlling the spread of colorectal cancer that cannot be removed by surgery. The goal is to see if this drug can help slow down the progression of the disease.
Nivolumab
is an immune checkpoint inhibitor used in the trial. This medication helps the body's immune system recognize and attack cancer cells more effectively. By blocking certain proteins that prevent the immune system from attacking cancer, nivolumab can enhance the body's natural defenses against the tumor. The study aims to determine if using nivolumab in combination with chemotherapy can improve outcomes for patients with metastatic colorectal cancer.

What is already known about the treatment

Oxaliplatin
Oxaliplatin is administered intravenously, meaning it is given through a vein, typically in a hospital or clinic setting. It is currently used in the treatment of colorectal cancer, particularly in cases where the cancer has spread and cannot be surgically removed. The main therapeutic use of oxaliplatin is to stop the growth of cancer cells by interfering with their DNA, which is the genetic material inside cells. It belongs to a class of drugs known as platinum-based chemotherapy agents, which are known for their ability to damage the DNA of cancer cells, leading to cell death.
Nivolumab
Nivolumab is given as an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. It is an immune checkpoint inhibitor used in the treatment of various cancers, including colorectal cancer, by helping the immune system recognize and attack cancer cells. Nivolumab works by blocking a protein called PD-1 on immune cells, which can otherwise prevent the immune system from attacking cancer cells effectively. It is classified as an immunotherapy drug, which enhances the body's natural defenses to fight cancer.

Investigated diseases

Colorectal cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It typically starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. As the cancer progresses, it can invade and destroy normal tissue nearby and may spread to other parts of the body. The progression of colorectal cancer can vary, with some cases growing slowly over several years. Symptoms may not appear until the disease is advanced, and they can include changes in bowel habits, blood in the stool, and abdominal discomfort.