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Study of avelumab and cetuximab combination treatment after TPEx chemotherapy for patients with recurrent or metastatic head and neck cancer receiving first-line therapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck, a type of cancer that has either returned after initial treatment or spread to other parts of the body. The study will evaluate a treatment approach called TPEx, which combines several anti-cancer medications, followed by a maintenance therapy using two drugs: avelumab and cetuximab.

The treatment plan consists of two phases. In the first phase, patients will receive TPEx therapy which includes docetaxel, cisplatin or carboplatin, and cetuximab. After this initial treatment, patients will continue with maintenance therapy using a combination of avelumab and cetuximab. Both medications are given through an infusion into a vein.

The main purpose of this study is to determine how well this combination treatment works in terms of helping patients live longer. The study will also track how the disease responds to treatment and monitor any side effects that patients may experience, particularly during the maintenance phase of treatment with avelumab and cetuximab.

The research process

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

  1. Step 1

    Initial treatment phase - TPEx

    You will receive a combination treatment called TPEx, which consists of three medications given through an intravenous infusion:

    - Docetaxel (Docetaxel Hospira)

    - Platinum-based drug (either Cisplatin or Carboplatin, depending on your medical condition)

    - Cetuximab (Erbitux)

  2. Step 2

    Maintenance phase

    After completing the initial TPEx treatment, you will begin a maintenance phase that includes two medications:

    - Avelumab (Bavencio) given through intravenous infusion

    - Cetuximab (Erbitux) given through intravenous infusion

  3. Step 3

    Regular monitoring

    Throughout the study, your condition will be monitored through:

    - Regular blood tests to check your blood cell counts and organ function

    - Imaging scans (CT or MRI) to assess how your disease responds to treatment

    - Regular checks of your general health and any side effects

  4. Step 4

    Follow-up period

    After completing the treatment, you will continue to be monitored for:

    - Any changes in your health condition

    - Long-term effects of the treatment

    The total study duration is expected to continue until October 2028

Who can join the trial?

17 criteria

  • Age between 18 and 75 years (both men and women can participate)
  • Must have normal calcium levels in blood (medical treatment to maintain proper calcium levels is allowed)
  • Confirmed diagnosis of recurring or spreading head and neck cancer that cannot be cured with local treatments
  • Must have a specific protein called PD-L1 present in tumor tissue samples
  • Must have good physical performance status (ECOG score of 0 or 1, meaning able to perform most daily activities)
  • Must be able to receive specific cancer treatments including TPEx, docetaxel, cetuximab, and avelumab
  • Must have documentation of p16 status (a marker related to HPV virus) for throat cancer cases
  • Must have tumors that can be measured by CT or MRI scans
  • If previously treated with radiation therapy alone:
    • Must wait at least 4 weeks after curative radiation
    • Must wait at least 2 weeks after palliative radiation
    • Must meet specific blood test requirements:
      • Adequate white blood cell count
      • Adequate neutrophil count (type of white blood cells)
      • Adequate platelet count
      • Adequate hemoglobin level
      • Proper liver function tests
      • Normal bilirubin levels
      • Adequate kidney function

Who cannot join the trial?

12 criteria

  • Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies (medications that affect immune system response)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • History of other malignancies (other types of cancer) within 5 years before starting the study
  • Active autoimmune disease requiring systemic treatment (conditions where immune system attacks healthy cells)
  • Uncontrolled or significant heart disease
  • Active infection requiring treatment
  • Known HIV infection (human immunodeficiency virus)
  • Active hepatitis B or hepatitis C infection (liver infections)
  • Pregnant or breastfeeding women
  • Previous organ transplantation
  • Use of systemic corticosteroids (strong anti-inflammatory medications) or other immunosuppressive medications
  • Any condition that would interfere with the safety or study evaluations
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Investigated drugs

  • Avelumab

    is a type of immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein called PD-L1, which cancer cells use to hide from your immune system. This allows your body's natural defenses to better recognize and attack the cancer.

  • Cetuximab

    is a targeted therapy medication that specifically attaches to proteins found on cancer cells called EGFR (epidermal growth factor receptor). By blocking these proteins, it helps stop cancer cells from growing and spreading. It's commonly used to treat head and neck cancers.

  • TPEx

    is a combination therapy regimen used in treating head and neck cancers. It combines different medications to fight cancer cells in multiple ways, making the treatment more effective than using single medications alone.

What is already known about the treatment

  • Avelumab

    A monoclonal antibody medication administered through intravenous infusion, which belongs to the class of immunotherapy drugs known as PD-L1 inhibitors. This medication works by helping the immune system recognize and attack cancer cells by blocking the PD-L1 protein that cancer cells use to hide from immune cells, particularly effective in treating various types of cancers including head and neck squamous cell carcinoma. It is currently approved for several cancer treatments and continues to be studied in clinical trials for expanding its therapeutic applications.

  • Cetuximab

    An intravenously administered targeted therapy medication that belongs to the class of EGFR (epidermal growth factor receptor) inhibitors. This monoclonal antibody works by attaching to EGFR proteins on cancer cells, blocking their growth signals and helping to stop cancer progression, particularly effective in treating head and neck cancers and colorectal cancer. It is well-established in medical practice and is often used in combination with other cancer treatments to enhance therapeutic outcomes.

Investigated diseases

Squamous Cell Carcinoma of the Head and Neck - A type of cancer that begins in the squamous cells that line the moist surfaces inside the head and neck area. This cancer can develop in various places including the mouth, throat, larynx, and sinuses. The disease can spread (metastasize) to nearby lymph nodes and other parts of the body. When described as recurrent, it means the cancer has returned after initial treatment, while metastatic indicates the cancer has spread to distant parts of the body. The condition typically develops gradually and may affect normal functions like speaking, swallowing, and breathing. The disease can occur in multiple locations simultaneously within the head and neck region.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510559-41-00Protocol codeGORTEC 2024-01Estimated enrolment73 patientsSponsorGroupe Oncologie Radiotherapie Tete Cou

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).