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Study Comparing Avelumab, Cetuximab, and Radiotherapy with Standard Treatments for Patients with Advanced Head and Neck Squamous Cell Carcinoma

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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 squamous cell carcinoma that affects the head and neck. This cancer can occur in areas such as the mouth, throat, and voice box. The study is specifically looking at cases that are locally advanced, meaning the cancer has spread to nearby tissues but not to distant parts of the body. The trial will compare different treatment options to see which is more effective. One treatment being tested is a combination of two medications, avelumab and cetuximab, along with radiotherapy. Avelumab is a type of medication known as an immunotherapy, which helps the body's immune system fight cancer. Cetuximab is a targeted therapy that works by blocking the growth of cancer cells. The study will compare this combination to the standard treatment, which includes either cisplatin with radiotherapy or cetuximab with radiotherapy.

The purpose of the study is to determine if the new combination of avelumab and cetuximab with radiotherapy is better than the standard treatments in preventing the cancer from getting worse. Participants in the study will be randomly assigned to receive either the new combination treatment or one of the standard treatments. The study will monitor the participants over time to see how well the treatments work and to check for any side effects. The trial will also look at how the treatments affect the participants' quality of life, including their ability to swallow and speak.

This study is important because it aims to find more effective treatments for people with locally advanced squamous cell carcinoma of the head and neck. By comparing the new combination treatment to the standard treatments, researchers hope to improve outcomes for patients with this type of cancer. The study will continue until the end of 2027, and the results will help guide future treatment options for this disease.

The research process

The trial runs in 6 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, eligibility is confirmed based on specific criteria such as age, health status, and type of cancer. The cancer must be squamous cell carcinoma located in the oral cavity, oropharynx, hypopharynx, or larynx, and must be at stage III, IVa, or IVb.

  2. Step 2

    Treatment assignment

    Participants are randomly assigned to receive either the new treatment combination or the standard treatment. The new treatment involves a combination of avelumab and cetuximab with radiotherapy, while the standard treatment involves cisplatin with radiotherapy or cetuximab with radiotherapy.

  3. Step 3

    Treatment administration

    The medications are administered as solutions for infusion. Erbitux (cetuximab) is given as a 5 mg/mL solution, Cisplatin is provided as a 1 mg/mL solution, and Bavencio (avelumab) is given as a 20 mg/mL concentrate. The specific dosage and frequency depend on the treatment group assigned.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, regular monitoring is conducted to assess the response to treatment. This includes imaging tests and evaluations based on specific criteria to track cancer progression or response.

  5. Step 5

    Completion of treatment

    After completing the treatment regimen, follow-up assessments are conducted to evaluate overall survival, incidence of cancer recurrence, and any side effects experienced during the trial.

  6. Step 6

    End of trial participation

    The trial is expected to conclude by December 31, 2027. Participants will have contributed valuable data to help determine the effectiveness of the new treatment compared to standard care.

Who can join the trial?

16 criteria

  • Must be between 18 and 80 years old.
  • Must have a good general health status, known as Performance Status ECOG 0-1, which means being fully active or having some symptoms but still able to carry out light work.
  • Must have a type of cancer called squamous cell carcinoma that has not been treated before.
  • Cancer must be at Stage III, IVa, or IVb. Stage III and IVa mean the cancer can be operated on but hasn't been yet, while Stage IVb means it cannot be removed by surgery.
  • Cancer must be located in the oral cavity (mouth), oropharynx (part of the throat behind the mouth), hypopharynx (lower part of the throat), or larynx (voice box).
  • Must be able to receive a specific chemotherapy drug called cisplatin at a high dose for 3 cycles. This includes meeting certain health criteria:
  • Kidney function must be good, with a creatinine clearance or glomerular filtration rate of at least 60 mL/min.
  • Blood counts must be adequate: neutrophils (a type of white blood cell) at least 1,500/μL, platelets at least 100,000/μL, and hemoglobin at least 10 g/dL.
  • Liver function tests, AST and ALT, must be less than 2 times the normal limit, and total bilirubin must be 1.5 mg/dL or less.
  • Serum albumin (a protein in the blood) must be at least 35 g/L.
  • No significant peripheral neuropathy (nerve damage) greater than grade 1.
  • No sensorineural hearing loss, confirmed by a hearing test.
  • Heart function must be good enough to handle extra fluids without significant heart disease.
  • Must not be taking a medication called prophylactic phenytoin.
  • If aged 71-74, must have a perfect health status (PS 0) and be fit according to a special health evaluation for older adults.
  • Overall health must be suitable for high-dose cisplatin and radiotherapy, as judged by the doctor.

Who cannot join the trial?

5 criteria

  • Patients who have already received treatment for their squamous cell carcinoma cannot participate. This means if you have had any previous treatment for this type of cancer, you are not eligible.
  • Patients with cancer that is not in the oral cavity, oropharynx, hypopharynx, or larynx are excluded. These are specific areas in the mouth and throat.
  • Patients with cancer that is not at Stage III, Stage IVa (operable but not operated), or Stage IVb (non-resectable) are not eligible. These stages describe how advanced the cancer is.
  • 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 part of a vulnerable population are not eligible. This means people who might need special protection or care are not included.
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Investigated drugs

  • Avelumab

    is a type of medication known as an immune checkpoint inhibitor. It works by helping the immune system recognize and attack cancer cells more effectively. In this trial, it is being tested in combination with other treatments to see if it can improve outcomes for patients with a specific type of head and neck cancer.

  • Cetuximab

    is a medication that targets a specific protein on the surface of cancer cells, which can help slow down or stop their growth. It is often used in combination with other treatments, such as radiation therapy, to enhance its effectiveness against cancer.

  • Cisplatin

    is a chemotherapy drug that works by damaging the DNA of cancer cells, which can prevent them from dividing and growing. It is commonly used in combination with radiation therapy to treat various types of cancer, including head and neck cancer.

  • Radiotherapy

    is a treatment that uses high-energy rays to target and kill cancer cells. It is often used in combination with other treatments, such as chemotherapy or targeted therapy, to increase its effectiveness in treating cancer.

What is already known about the treatment

  • Avelumab

    Avelumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently being studied in clinical trials for its effectiveness in treating certain types of cancer, including squamous cell carcinoma of the head and neck. The main therapeutic indication for avelumab is its use as an immunotherapy to help the body's immune system attack cancer cells. At the molecular level, avelumab works by blocking the PD-L1 protein, which can help prevent cancer cells from evading the immune system. It is classified as a monoclonal antibody in pharmacology.

  • Cetuximab

    Cetuximab is administered through an intravenous infusion, often in a hospital or clinic. It is an established medication in the treatment of certain cancers and is being evaluated in combination with other therapies for head and neck cancer. The primary therapeutic use of cetuximab is to treat cancers by targeting the epidermal growth factor receptor (EGFR) on cancer cells, which can inhibit their growth. Its mechanism of action involves binding to EGFR, blocking the signals that promote cancer cell proliferation. Cetuximab is classified as a monoclonal antibody in pharmacological terms.

Investigated diseases

Squamous Cell Carcinoma of the Head and Neck – This is a type of cancer that begins in the squamous cells, which are flat cells found in the lining of the oral cavity, oropharynx, hypopharynx, or larynx. It is characterized by the uncontrolled growth of abnormal cells in these areas. The disease can be classified into different stages, such as Stage III, Stage IVa, and Stage IVb, depending on the extent of the tumor and its spread to nearby tissues or lymph nodes. In its early stages, the cancer may not cause noticeable symptoms, but as it progresses, it can lead to difficulties in swallowing, changes in voice, or persistent sore throat. The progression of the disease can vary, with some cases remaining localized while others may spread to other parts of the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513964-24-00Protocol codeGORTEC 2017-01Estimated enrolment707 patientsSponsorGroupe Oncologie Radiotherapie Tete Cou

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