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Study on Atezolizumab with FOLFOX for Stage III Colon Cancer with Deficient DNA Mismatch Repair

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 a type of colon cancer known as stage III colon cancer with a specific characteristic called deficient DNA mismatch repair (dMMR). The study is investigating the effects of a treatment that combines standard chemotherapy with a medication called atezolizumab, which is also known by its code name RO5541267. The chemotherapy regimen used in this study is called FOLFOX, which includes the drugs Leucovorin, 5-Fluorouracil, and Oxaliplatin. The purpose of the study is to determine if adding atezolizumab to the standard chemotherapy can improve the time patients remain free from cancer recurrence or death, compared to using the chemotherapy alone.

Participants in the study will receive either the standard chemotherapy treatment or the combination of chemotherapy and atezolizumab. The treatment will be administered through an intravenous infusion, which means the medication is given directly into a vein. The study will continue for a period of time to monitor the effects of the treatment on the participants' health and to see if the cancer returns. The study aims to provide valuable information on whether the addition of atezolizumab can offer better outcomes for patients with this type of colon cancer.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to track the progress of their treatment. The study will help researchers understand if the combination of atezolizumab with standard chemotherapy can be a more effective treatment option for patients with stage III colon cancer and deficient DNA mismatch repair. This research could potentially lead to improved treatment strategies for this specific group of patients.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The treatment begins with the administration of a combination of medications. These include calcium folinate pentahydrate, fluorouracil, atezolizumab, and oxaliplatin.
The medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.
The specific dosages and frequency of administration are determined by the healthcare provider based on individual patient needs and the study protocol.
Step 2
Combination therapy
During this phase, the patient receives a combination of atezolizumab with the FOLFOX regimen, which includes fluorouracil, leucovorin (calcium folinate), and oxaliplatin.
This combination is intended to enhance the effectiveness of the treatment by targeting cancer cells more effectively.
The treatment is administered through intravenous infusion, and the duration of this phase is determined by the healthcare provider.
Step 3
Monotherapy phase
Following the combination therapy, the patient transitions to a monotherapy phase with atezolizumab alone.
This phase aims to maintain the therapeutic effects achieved during the combination therapy.
The administration continues via intravenous infusion, and the frequency and duration are specified by the healthcare provider.
Step 4
Monitoring and follow-up
Throughout the trial, regular monitoring is conducted to assess the patient's response to the treatment and to identify any potential side effects.
Follow-up visits are scheduled to evaluate the patient's health status and to ensure the treatment is proceeding as planned.
The primary goal is to determine the disease-free survival, which is the time from the start of the trial to the first sign of cancer recurrence or death.

Who can join the trial?

14 criteria

Must have a confirmed diagnosis of **stage III colon adenocarcinoma**. This means the cancer started in the colon and is at stage III, which involves certain levels of spread to nearby lymph nodes but not to distant parts of the body.
Must have a **deficient DNA mismatch repair (dMMR)**. This is a condition where the body's system for fixing DNA mistakes is not working properly. It is checked by looking at specific proteins in the tumor.
Must have had the tumor completely removed through surgery. If the tumor was attached to nearby structures, the surgery must have removed it all in one piece.
The entire tumor must be located in the colon, not the rectum.
Must be at least **18 years old**.
Must have an **ECOG performance status** of 2 or less. This is a scale that measures how well a person can perform daily activities, with lower numbers indicating better ability.
Must not be pregnant or nursing. Women who can have children must have a negative pregnancy test before joining the study and agree to use birth control during the study.
Must have a **platelet count** of at least 100,000 per cubic millimeter. Platelets are cells that help with blood clotting.
Must have a **creatinine level** that is not more than 1.5 times the normal upper limit, or a creatinine clearance of at least 45 mL/min. Creatinine is a waste product in the blood, and these levels help assess kidney function.
Must have a **total bilirubin level** that is not more than 1.5 times the normal upper limit, except for those with Gilbert disease. Bilirubin is a substance made during the breakdown of red blood cells.
Must have **AST/ALT levels** that are not more than 2.5 times the normal upper limit. These are enzymes that help assess liver function.
Must have a **thyroid-stimulating hormone (TSH)** level within normal limits. If TSH is abnormal, but another test called free T4 is normal, and the person feels well, they can still participate.
Must have an **absolute neutrophil count (ANC)** of at least 1500 per cubic millimeter. Neutrophils are a type of white blood cell important for fighting infections.
Must have available **tumor tissue** for further testing to confirm dMMR status.

Who cannot join the trial?

9 criteria

Patients with any other type of cancer besides stage III colon adenocarcinoma with deficient MMR (a specific genetic feature of the cancer).
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who have medical conditions or are taking medications that could interfere with the study treatment.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who have participated in another clinical trial recently.
Patients who have a history of severe allergic reactions to the study drugs.
Patients who are pregnant or breastfeeding.
Patients with serious health conditions that could affect their safety during the study.

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Verified sites

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

Charite Universitaetsmedizin Berlin KöR
Verified
Berlin, Germany
Klinikum der Universitaet Muenchen AöR
Verified
Munich, Germany
Technische Universitaet Dresden
Verified
Dresden, Germany

Trial locations

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Investigated drugs

Atezolizumab
is an immunotherapy medication used in this trial. It works by helping the body's immune system recognize and attack cancer cells more effectively. In this study, it is being tested to see if it can improve the outcomes for patients with stage III colon cancer when used in combination with standard chemotherapy.
FOLFOX
is a standard chemotherapy regimen used to treat colon cancer. It is a combination of three drugs: folinic acid, fluorouracil, and oxaliplatin. These medications work together to stop the growth of cancer cells by interfering with their DNA and preventing them from dividing and multiplying. In this trial, FOLFOX is used alone or in combination with atezolizumab to see which approach is more effective.

What is already known about the treatment

Atezolizumab – Atezolizumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating stage III colon cancer with deficient DNA mismatch repair. It is an immunotherapy drug that works by blocking a protein called PD-L1, which helps cancer cells evade the immune system. By inhibiting this protein, atezolizumab enables the immune system to better recognize and attack cancer cells. It is classified as a monoclonal antibody and is being evaluated for its potential to improve disease-free survival when combined with standard chemotherapy.

Investigated diseases

Stage III Colon Adenocarcinoma with Deficient Mismatch Repair (dMMR) – This is a type of colon cancer where the tumor has spread to nearby lymph nodes but not to distant body parts. It is characterized by a deficiency in the mismatch repair system, which is responsible for correcting errors during DNA replication. This deficiency can lead to an accumulation of mutations in the tumor cells. The disease typically progresses as the cancer cells grow and invade surrounding tissues. Patients may experience symptoms such as changes in bowel habits, abdominal pain, and weight loss. The progression of the disease can vary, with some cases advancing more rapidly than others.