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Comparing Two Treatment Lengths of Cetuximab, Avelumab, Cisplatin, and Docetaxel for Patients with Returning Spread Head and Neck Cancer

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What is this trial about?

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

This study is looking at recurrent metastatic head and neck cancer, which means cancer that started in the head and neck area and has either come back after treatment or has spread to other parts of the body. The study will use a combination of medications given through infusion into a vein. These medications include cetuximab, which is an antibody that targets cancer cells, avelumab, which is an antibody that helps the immune system fight cancer, and two chemotherapy drugs called cisplatin and docetaxel. Some patients may receive carboplatin instead of cisplatin depending on what is most suitable for them. The purpose of the study is to compare quality of life at 18 weeks after starting treatment between patients who receive two cycles of this combination therapy versus those who receive four cycles.

Patients in the study will be randomly assigned to one of two groups. One group will receive two cycles of the combination treatment, while the other group will receive four cycles. A cycle is a period of time during which the medications are given according to a specific schedule. All patients will receive the same medications, but for different lengths of time. The study will measure how the treatment affects quality of life, particularly how well patients can perform their daily activities and roles. Treatment can continue for up to 104 weeks depending on how the cancer responds and how well the patient tolerates the medications.

The study will also look at other important measures such as how long patients live without their cancer getting worse, how long patients survive overall, how many patients have their tumors shrink or disappear, and how long the response to treatment lasts. Patients will be asked to complete questionnaires about their quality of life and stress levels throughout the study to help researchers understand how the different treatment durations affect their daily lives and well-being.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Random assignment to treatment group

    Upon joining the study, you will be randomly assigned to one of two treatment groups. Group A will receive two cycles of combination therapy, while Group B will receive four cycles of combination therapy.

    The assignment is random, similar to flipping a coin, and neither you nor your doctor can choose which group you will be in.

  2. Step 2

    Beginning of combination therapy

    You will receive a combination of four medications administered through infusion, which means the medications will be given directly into your vein.

    The four medications are: cetuximab, avelumab, cisplatin, and docetaxel. These medications work together to treat your cancer.

    Each treatment cycle consists of administering these medications according to a specific schedule.

  3. Step 3

    Completion of assigned treatment cycles

    If you are assigned to Group A, you will complete two cycles of the combination therapy.

    If you are assigned to Group B, you will complete four cycles of the combination therapy.

    The exact duration and frequency of each cycle will be determined by the study protocol.

  4. Step 4

    Quality of life assessment at 18 weeks

    At 18 weeks after starting treatment, you will be asked to complete questionnaires about your quality of life.

    These questionnaires will ask about your daily functioning, how you feel, and how the treatment affects your life.

    The questionnaires used include the QLQ-C30 and QLQ H&N35, which are standardized tools designed to understand your experience.

    You will also complete the Perceived Stress Questionnaire, which measures your current stress levels and how you are coping.

  5. Step 5

    Ongoing quality of life assessments

    Throughout the study, you will be asked to complete quality of life questionnaires at regular intervals.

    These assessments help measure how the treatment affects your daily activities, emotional well-being, and overall quality of life over time.

  6. Step 6

    Regular monitoring and imaging

    You will undergo regular monitoring to assess how your cancer is responding to treatment.

    This monitoring includes imaging scans to measure your tumor size and determine if the cancer is growing, shrinking, or staying the same.

    The measurements will follow RECIST 1.1 criteria, which is a standardized way to evaluate tumor response.

  7. Step 7

    Continued follow-up

    After completing your assigned treatment cycles, you will continue to be followed throughout the study period.

    This follow-up includes monitoring for disease progression, survival, and ongoing quality of life assessments.

    The study is expected to continue until January 2030.

Who can join the trial?

20 criteria

  • You must be 18 years of age or older
  • You must have recurrent or metastatic head and neck squamous cell carcinoma, which means cancer that started in the head or neck area and has either come back after treatment or spread to other parts of the body. This cancer must be confirmed by examining tissue or cells under a microscope
  • Your cancer cannot be treated with surgery or radiation aimed at curing the disease
  • Cancer that started in the nasopharynx (the upper part of the throat behind the nose) or cancer where the original location is unknown are not included in this study
  • Your tumor must have measurable disease according to RECIST 1.1 criteria, which is a standard way doctors measure tumors to track if they are growing or shrinking
  • You must have a PD-L1 CPS score of 1 or higher. This is a test that measures a specific protein on cancer cells, which helps predict how your cancer might respond to certain treatments
  • If your cancer started in the oropharynx (the middle part of the throat including the tonsils and base of tongue), you need to have a p16 IHC test that shows HPV association. This test checks if your cancer is related to the human papillomavirus
  • Your ECOG performance status must be 0 or 1, which means you are able to care for yourself and perform light activities, even if you cannot do heavy physical work
  • You must not have received any previous treatment with medications for your recurrent or metastatic cancer. If you received chemotherapy and radiation for earlier stage disease, this must have been completed at least 6 months before joining the study
  • Any side effects from previous cancer treatments must be resolved or very mild (grade 1 or less according to CTCAE v.5, which is a standard scale for measuring side effects)
  • Stored tumor tissue from a previous biopsy or surgery must be available (either a tissue block or at least 20 slides)
  • There must be documentation showing that your cancer has grown or worsened after previous treatment that was intended to cure your disease
  • You must be willing to complete questionnaires about your quality of life throughout the study
  • Your blood counts must be adequate: absolute neutrophil count (a type of white blood cell that fights infection) must be at least 1,500 per microliter, platelets (cells that help blood clot) must be at least 100,000 per microliter, and hemoglobin (protein in red blood cells that carries oxygen) must be at least 9.0 grams per deciliter
  • Your liver function must be adequate: total bilirubin (a substance that shows how well your liver is working) must be no more than 1.5 times the upper limit of normal, and AST and ALT (liver enzymes) must be no more than 2.5 times the upper limit of normal
  • Your kidney function must be adequate: serum creatinine (a waste product that shows how well your kidneys are working) must be no more than 1.5 times the upper limit of normal, or your creatinine clearance (a measure of kidney function) must be at least 60 milliliters per minute
  • If you are a woman who can become pregnant, you must have a negative pregnancy test before starting the study and agree to use highly effective birth control during the study and for at least 30 days after the last treatment. Highly effective methods include birth control pills, injections, implants, intrauterine devices, partner with vasectomy, or complete abstinence from sex
  • If you are a man, you must agree to use adequate birth control methods during the study
  • Women who have gone through menopause (no menstrual period for at least 12 months) do not need to use birth control
  • You must provide written informed consent, which means you agree to participate after understanding the study details, before any study procedures begin

Who cannot join the trial?

3 criteria

  • The source data does not provide specific exclusion criteria (reasons why a patient cannot participate) for this clinical trial
  • If you are interested in participating in this study, you would need to contact the research team directly to learn about any conditions or health situations that would prevent you from joining
  • Typically, exclusion criteria may include things like certain other medical conditions, previous treatments, laboratory test results, or medications you are taking, but these specific details are not available in the provided information
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Investigated drugs

  • Cetuximab

    is a medicine used to treat cancer. It works by blocking certain signals that help cancer cells grow and survive. In this trial, it is given as part of a combination treatment for head and neck cancer that has come back or spread to other parts of the body.

  • Avelumab

    is a type of immunotherapy medicine that helps your immune system fight cancer. It works by allowing your body's natural defenses to recognize and attack cancer cells more effectively. In this trial, it is used together with other medicines to treat head and neck cancer.

  • Cisplatin

    is a chemotherapy medicine that kills cancer cells by damaging their ability to grow and multiply. It has been used for many years to treat different types of cancer. In this trial, it is part of a combination treatment for head and neck cancer.

  • Docetaxel

    is a chemotherapy medicine that stops cancer cells from dividing and growing. It works by interfering with the internal structure of cells that is needed for them to multiply. In this trial, it is used along with other medicines to treat head and neck cancer that has returned or spread.

What is already known about the treatment

  • Cetuximab

    Cetuximab is a targeted cancer medication given through an intravenous infusion (directly into a vein) that is approved and widely used in medical practice for treating various cancers, particularly head and neck cancer and colorectal cancer. It works by blocking a protein called EGFR (epidermal growth factor receptor) found on the surface of cancer cells, which prevents the cells from receiving signals that tell them to grow and divide. This medication belongs to a class of drugs called monoclonal antibodies, which are designed to target specific proteins on cancer cells to slow down or stop tumor growth.

  • Avelumab

    Avelumab is an immunotherapy medication administered as an intravenous infusion that is approved for treating certain types of cancer by helping the body's immune system fight cancer cells. It works by blocking a protein called PD-L1 on cancer cells, which normally helps tumors hide from the immune system, allowing the patient's own immune cells to recognize and attack the cancer more effectively. This drug is classified as an immune checkpoint inhibitor, a type of monoclonal antibody that has become an important treatment option in modern cancer therapy.

  • Cisplatin

    Cisplatin is a chemotherapy medication given through intravenous infusion that has been a standard cancer treatment for decades and is used to treat many types of cancer including head and neck, lung, bladder, and testicular cancers. It works by damaging the DNA inside cancer cells, which prevents them from dividing and eventually causes the cancer cells to die. This medication belongs to a class of chemotherapy drugs called platinum-based compounds, which are among the most effective and commonly used cancer treatments available.

  • Docetaxel

    Docetaxel is a chemotherapy medication administered through intravenous infusion that is approved and commonly used to treat various cancers including breast, lung, prostate, and head and neck cancers. It works by interfering with the internal structure of cancer cells, specifically targeting tiny tubes called microtubules that cells need to divide, which causes the cancer cells to stop growing and die. This drug belongs to a class of chemotherapy medications called taxanes, which are plant-derived compounds that have proven effective in treating many different types of cancer.

Investigated diseases

Recurrent Metastatic Head and Neck Cancer – This is a condition where cancer that originally developed in the head and neck region has come back after previous treatment and has spread to other parts of the body. Head and neck cancer typically begins in the cells lining the moist surfaces inside the head and neck, such as the mouth, nose, and throat. When the cancer is described as recurrent, it means it has returned after a period of treatment and apparent control. The metastatic aspect indicates that cancer cells have traveled through the bloodstream or lymphatic system to form new tumors in distant organs or tissues. As the disease progresses, patients may experience various symptoms related to both the original site and the areas where the cancer has spread. The recurrent and metastatic nature of this condition means it requires ongoing medical attention and monitoring.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521738-27-00Protocol codeMS062202_0168Estimated enrolment126 patientsSponsorCharite Universitaetsmedizin Berlin KöR

sourced from the EU Clinical Trials Register and site verification

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