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Study Comparing Avelumab and Standard Chemotherapy for Patients with Metastatic Colorectal Cancer with Microsatellite Instability

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 cancer known as colorectal metastatic cancer with microsatellite instability (MSI). This is a form of cancer that starts in the colon or rectum and has spread to other parts of the body. The study is comparing the effectiveness and tolerance of a medication called avelumab against standard chemotherapy treatments. Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells. The standard chemotherapy treatments in this study may include drugs such as bevacizumab, folinic acid, fluorouracil, aflibercept, irinotecan, panitumumab, oxaliplatin, and cetuximab.

The purpose of this study is to compare how well patients respond to avelumab versus the standard chemotherapy treatments. Participants in the study will receive either avelumab or one of the standard chemotherapy treatments. The study will last for a period of up to 60 weeks, during which time the participants will receive their assigned treatment. The treatments are given through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein.

Throughout the study, doctors will monitor the participants' health and the progression of their cancer. They will use imaging tests to check for changes in the size of the cancer and assess how well the treatment is working. The study will also look at the side effects of the treatments to understand how well patients tolerate them. The goal is to find out which treatment is more effective and better tolerated by patients with this specific type of colorectal cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, the patient is randomly assigned to one of two groups. One group receives avelumab, and the other receives standard chemotherapy treatment.

  2. Step 2

    Treatment administration

    Patients in the avelumab group receive the medication through an intravenous infusion. The specific dosage and frequency are determined by the study protocol.

    Patients in the standard chemotherapy group receive a combination of medications, which may include bevacizumab, folinic acid, fluorouracil, aflibercept, irinotecan, panitumumab, oxaliplatin, and cetuximab. These are administered intravenously, with dosages and schedules specified by the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, regular monitoring is conducted to assess the patient's response to treatment. This includes imaging tests to evaluate tumor size and progression.

    Blood tests and other assessments are performed to monitor health and detect any side effects.

  4. Step 4

    Evaluation of treatment response

    The effectiveness of the treatment is evaluated using criteria such as progression-free survival, overall survival, and objective response rate.

    The patient's quality of life is also assessed using a standardized questionnaire.

  5. Step 5

    End of treatment

    The treatment continues until the study's end date or until the patient experiences unacceptable side effects or disease progression.

    At the end of the study, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

14 criteria

  • The patient must have a type of cancer called **colorectal adenocarcinoma** that has spread to other parts of the body and cannot be removed by surgery.
  • The patient should have a **WHO performance status** of 2 or less, which means they are able to carry out all self-care but are unable to carry out any work activities.
  • The patient should have a life expectancy of at least 3 months.
  • The patient must have previously tried chemotherapy that includes certain drugs like **fluoropyrimidine** (capecitabine or 5FU), possibly with other drugs like irinotecan, oxaliplatin, cetuximab, bevacizumab, panitumumab, or aflibercept, and it did not work or caused unacceptable side effects.
  • The patient should have certain blood counts: **PNN** (a type of white blood cell) greater than 1500/mm³, **platelets** greater than 100,000/mm³, and **hemoglobin** (Hb) greater than 9 g/dL.
  • A sample of the patient's tumor must be available for testing.
  • The patient should have certain liver function tests within specific limits: **total bilirubin** less than 25 µmol/L, **ASAT** and **ALAT** (liver enzymes) less than 3 times the normal limit, or less than 5 times if there is liver involvement, **PT** (prothrombin time) greater than 60%, and **PAL** (another liver enzyme) less than 2.5 times the normal limit, or less than 5 times if there is liver involvement.
  • The patient should have a **creatinine clearance** (a measure of kidney function) greater than 50 ml/min.
  • The patient must be part of a social security scheme.
  • The patient must be informed about the study and sign a consent form agreeing to participate.
  • The patient must have a specific type of genetic change in their cancer called **MSI-H**, determined by tests that look for the loss of certain proteins (MLH1, MSH2, MSH6, and/or PMS2).
  • The patient must have at least one tumor or metastasis that can be measured according to specific criteria called **RECIST v1.1**.
  • The patient must have information about their **RAS** and **BRAF** gene status.
  • The patient must be at least 18 years old.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer besides colorectal metastatic cancer with microsatellite instability cannot participate. This means the cancer has spread from the colon or rectum to other parts of the body and has a specific genetic feature called microsatellite instability.
  • Patients who have not been diagnosed with the specific type of cancer being studied are excluded.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are unable to follow the study procedures or attend required visits may be excluded.
  • Patients who have certain medical conditions that could interfere with the study or pose a risk to their health may not be eligible.
  • Patients who are pregnant or breastfeeding are typically excluded to avoid any potential risks to the baby.
  • Patients who are participating in another clinical trial at the same time may not be eligible.
  • Patients who have had a recent major surgery or are recovering from a major illness might be excluded.
  • Patients with a history of severe allergic reactions to any of the study medications or similar drugs may not participate.
  • Patients who have certain infections or diseases that could affect the study results or their safety might be excluded.
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Investigated drugs

  • Avelumab

    is a type of immunotherapy used in this clinical trial. It works by helping the body's immune system recognize and attack cancer cells. Avelumab is being tested to see if it is effective and well-tolerated in patients with colorectal metastatic cancer that has microsatellite instability.

  • Standard 2nd Line Treatment Chemotherapy

    refers to the usual chemotherapy treatments given to patients when the first line of treatment is not effective. In this trial, it is used as a comparison to see how well Avelumab performs against the standard treatment options for colorectal metastatic cancer.

What is already known about the treatment

Avelumab – Avelumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its effectiveness in treating colorectal metastatic cancer with microsatellite instability. The main therapeutic indication for Avelumab is as an immunotherapy agent, particularly in cancers with specific genetic markers. At the molecular level, Avelumab works by blocking the PD-L1 protein, which helps the immune system recognize and attack cancer cells. It is classified pharmacologically as a monoclonal antibody and an immune checkpoint inhibitor.

Investigated diseases

Colorectal Metastatic Cancer with Microsatellite Instability – This is a type of colorectal cancer that has spread to other parts of the body and is characterized by a high level of microsatellite instability, which is a condition of genetic hypermutability. Microsatellite instability occurs when the DNA mismatch repair system is not functioning properly, leading to an accumulation of mutations. This form of cancer often presents with symptoms such as changes in bowel habits, blood in the stool, and abdominal pain. As the disease progresses, it can lead to weight loss, fatigue, and further complications due to the spread of cancer to other organs. The progression of the disease is typically monitored through imaging studies to assess tumor growth and spread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517362-41-00Protocol codeProdige 54 SAMCOEstimated enrolment132 patientsSponsorFondation Franc.Cancerologie Digestive

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