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Study of Radiotherapy with Cetuximab and Xevinapant for Patients with Advanced Head and Neck Cancer Unfit for High-Dose Cisplatin

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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 called locally advanced squamous cell carcinoma of the head and neck. This is a condition where cancer cells form in the tissues of the head and neck area. The study is testing a new treatment combination that includes a drug called xevinapant, also known by its code name Debio 1143, along with another medication called cetuximab. These drugs will be used together with radiotherapy, which is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors.

The purpose of the study is to compare the effectiveness of the combination of xevinapant and cetuximab with radiotherapy against the standard treatment of cetuximab with radiotherapy and a placebo. Participants in the study will be randomly assigned to receive either the new treatment combination or the standard treatment. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the new treatment or the standard treatment until the study is completed. This helps ensure that the results are not biased.

Throughout the study, participants will receive regular assessments to monitor their health and the progress of their cancer. The study aims to determine if the new treatment combination can improve outcomes for patients who are not suitable for high-dose chemotherapy. The trial will last for several years, allowing researchers to gather enough data to make informed conclusions about the treatment's effectiveness and safety.

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

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive a combination of radiotherapy, cetuximab, and xevinapant. The other group will receive radiotherapy, cetuximab, and a placebo.

  2. Step 2

    Treatment administration

    If you are in the group receiving xevinapant, you will take it as an oral solution. The exact dosage and frequency will be provided by the study team.

    The cetuximab will be given as an IV infusion (intravenous infusion), which means it will be administered directly into your vein. The dosage and frequency will be determined by the study protocol.

  3. Step 3

    Radiotherapy sessions

    You will undergo radiotherapy sessions as part of your treatment. The number of sessions and the duration will be specified by the study team.

  4. Step 4

    Monitoring and assessments

    Throughout the study, your health and response to the treatment will be closely monitored. This will include regular assessments to check for any side effects and to evaluate the effectiveness of the treatment.

  5. Step 5

    Completion of the study

    At the end of the study period, you will have a final assessment to determine the overall outcome of the treatment. This will include a review of your health status and any changes in your condition.

Who can join the trial?

8 criteria

  • Must be a male or female aged 18 years or older and younger than 80 years.
  • Must have an ECOG PS of 0-1, which means having a good level of daily functioning.
  • Must have a confirmed diagnosis of locally advanced squamous cell carcinoma of the head and neck that has not been treated before. This includes certain stages and locations like the oral cavity, hypopharynx, and larynx. If the cancer is in the oropharynx, it must be HPV-negative or HPV-positive with a smoking history of more than 20 pack-years and meet specific stage criteria.
  • Must be able to swallow liquids or have a functioning feeding tube.
  • Must be ineligible for high-dose cisplatin treatment, which is a type of chemotherapy. This ineligibility is based on certain health conditions like reduced kidney function, hearing loss, nerve damage, heart issues, or being unfit if over 70 years old.
  • Must have adequate blood, kidney, and liver function as shown by specific medical tests.
  • Must agree to use appropriate contraception if applicable.
  • Must be able to give informed consent, meaning they understand and agree to the study's requirements and restrictions.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer that is not locally advanced squamous cell carcinoma of the head and neck cannot participate.
  • Patients who have received treatment with xevinapant or similar drugs before cannot participate.
  • Patients who have had a severe allergic reaction to cetuximab or similar drugs cannot participate.
  • Patients with uncontrolled medical conditions, such as high blood pressure or diabetes, cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are participating in another clinical trial cannot participate.
  • Patients with a history of another cancer within the last 5 years, except for certain skin cancers or in situ cervical cancer, cannot participate.
  • Patients with active infections, including HIV, hepatitis B, or hepatitis C, cannot participate.
  • Patients with significant heart problems, such as heart failure or a recent heart attack, cannot participate.
  • Patients with a history of severe lung disease cannot participate.
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Investigated drugs

  • Cetuximab

    is a medication used in this trial that works by targeting specific proteins on the surface of cancer cells. These proteins are involved in the growth and spread of cancer. By blocking these proteins, cetuximab can help slow down or stop the growth of cancer cells. It is often used in combination with other treatments to enhance their effectiveness.

  • Xevinapant

    is another medication being tested in this trial. It is designed to help make cancer cells more sensitive to radiation therapy. By doing this, xevinapant may improve the effectiveness of the radiation treatment, potentially leading to better outcomes for patients. This medication is being studied to see if it can help improve the chances of controlling the cancer when used alongside other treatments.

  • Radiotherapy

    is a common treatment for cancer that uses high-energy rays to target and destroy cancer cells. In this trial, radiotherapy is combined with medications to see if the combination can improve treatment results. The goal is to damage the cancer cells' DNA, which can stop them from growing and dividing, ultimately leading to their destruction.

What is already known about the treatment

  • Cetuximab

    Cetuximab is administered as an intravenous infusion, meaning it is given directly into a vein through a drip. It is currently used in medicine as a standard treatment for certain types of cancer, including squamous cell carcinoma of the head and neck. The main therapeutic indication for cetuximab is to treat locally advanced squamous cell carcinoma of the head and neck, especially in patients who cannot tolerate high-dose cisplatin. At the molecular level, cetuximab works by blocking a protein called the epidermal growth factor receptor (EGFR), which is involved in the growth and spread of cancer cells. It is classified as a monoclonal antibody, a type of targeted cancer therapy.

  • Xevinapant

    Xevinapant is taken orally, meaning it is administered by mouth in the form of a pill. It is currently being studied in clinical trials and is not yet widely available in medical practice. The main therapeutic indication for xevinapant is to improve outcomes in patients with locally advanced squamous cell carcinoma of the head and neck who are not suitable for high-dose cisplatin treatment. Xevinapant works at the molecular level by inhibiting proteins that help cancer cells survive, thereby making them more sensitive to treatment. It is classified as a small molecule inhibitor, which is a type of drug that interferes with specific cellular processes.

Investigated diseases

Locally advanced squamous cell carcinoma of the head and neck – This disease is a type of cancer that originates in the squamous cells, which are flat cells found in the lining of the head and neck region. It is considered locally advanced when the cancer has spread from its original site to nearby tissues or lymph nodes but not to distant parts of the body. The progression of this carcinoma involves the growth and spread of cancerous cells, which can invade surrounding tissues and structures. As the disease advances, it may cause symptoms such as difficulty swallowing, changes in voice, or persistent sore throat. The cancer can continue to grow and affect more areas within the head and neck if not managed.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502584-38-00Protocol codeGORTEC-2022-01Estimated enrolment377 patientsSponsorGroupe Oncologie Radiotherapie Tete Cou

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