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Study of ivonescimab alone or with ligufalimab versus pembrolizumab for patients with recurrent or metastatic head and neck squamous cell cancer

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What is this trial about?

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

This study involves patients with squamous cell carcinoma of the head and neck that has come back after treatment or has spread to other parts of the body. Head and neck squamous cell carcinoma is a type of cancer that develops in the moist tissues lining the mouth, throat, voice box, or related areas. The study will test different treatment approaches using medications given through a vein. The treatments being studied include ivonescimab, which is also known by its code name AK112, either used alone or combined with another medication called ligufalimab, which has the code name AK117. These treatments will be compared to a standard treatment called pembrolizumab, which is already approved for use in this type of cancer. All of these medications are types of immunotherapy that work by helping the body's immune system fight cancer cells.

The purpose of the study is to compare how long patients live when treated with ivonescimab combined with ligufalimab versus pembrolizumab alone, and also to compare ivonescimab alone versus pembrolizumab. The study will only include patients whose tumors test positive for a protein marker called PD-L1, which is measured using a specific scoring system. Patients will be randomly assigned to receive one of the three treatment options, and the study is designed to be open-label, meaning both patients and doctors will know which treatment is being given.

During the study, patients will receive their assigned treatment through an infusion into a vein at regular intervals over a treatment period that can last up to two years. The study doctors will monitor how well the treatment works by checking if tumors shrink or stop growing, and they will also watch for any side effects. Additional assessments will measure how the medications move through the body and whether the immune system develops any reaction to these treatments. Patients participating in this study must not have received previous treatment specifically for their cancer after it has spread or come back, although they may have had earlier treatments when the cancer was first diagnosed.

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

    Treatment assignment

    After joining the study, you will be assigned to one of three treatment groups. The assignment will be done randomly, which means neither you nor your doctor will choose which treatment you receive.

    The three possible treatment groups are: ivonescimab alone, ivonescimab combined with ligufalimab, or pembrolizumab.

  2. Step 2

    Treatment administration

    You will receive treatment through intravenous infusion, which means the medication will be given directly into your vein through a drip.

    The specific medication you receive will depend on which treatment group you were assigned to in step 1.

    If you are assigned to receive pembrolizumab, the medication used is called KEYTRUDA, which contains 25 milligrams of the active substance per milliliter of solution.

  3. Step 3

    Regular treatment cycles

    You will receive treatment in repeated cycles. The exact schedule will be determined based on your assigned treatment group.

    Each treatment session will involve receiving the medication through intravenous infusion.

  4. Step 4

    Monitoring and assessments

    Throughout the study, your health will be monitored regularly through various tests and examinations.

    Blood tests will be performed to check your organ function, including tests for your kidneys, liver, and blood cell counts.

    Imaging scans will be conducted to measure any changes in your tumor size according to standard criteria called RECIST v1.1.

    Your overall physical condition will be assessed using a scoring system called ECOG performance status, which measures how well you can perform daily activities.

  5. Step 5

    Safety monitoring

    Your safety will be monitored throughout the study by checking for any side effects or adverse reactions to the treatment.

    Blood samples will be collected to measure the levels of medication in your body, which is called pharmacokinetic assessment.

    Tests will also be performed to check if your body develops an immune response to the medication, which is called immunogenicity assessment.

  6. Step 6

    Response evaluation

    Your response to treatment will be evaluated regularly to determine if the tumor is shrinking, staying the same, or growing.

    The main measurement being tracked is overall survival, which means how long you live after starting treatment.

    Other measurements include progression-free survival, which tracks how long you live without the disease getting worse, and objective response rate, which measures whether your tumor shrinks.

    Disease control rate will also be measured, which indicates whether the treatment is keeping the disease stable or causing it to shrink.

  7. Step 7

    Continued participation

    You will continue to receive treatment and attend scheduled visits according to the study protocol.

    The study is expected to continue until the end of 2030, though your individual participation length may vary based on your response to treatment and overall health.

Who can join the trial?

14 criteria

  • You must be able to voluntarily give your written permission to participate in the study.
  • You must have adequate organ function, which means your body organs need to work well enough, including:
    • Blood cells: Your blood must have enough white blood cells (cells that fight infection), platelets (cells that help blood clot), and hemoglobin (protein that carries oxygen in red blood cells).
    • Kidneys: Your kidneys must work well enough to filter waste from your blood, and you should not have too much protein in your urine.
    • Liver: Your liver must work properly, shown by blood tests measuring bilirubin (a substance made when red blood cells break down), AST and ALT (enzymes that show liver health), and albumin (a protein made by the liver).
    • Blood clotting: Your blood must clot normally, unless you are already taking blood-thinning medication for medical reasons.
    • You must be willing and able to follow the study schedule, including visits, treatments, and laboratory tests.
    • You must be between 18 and 79 years old when you join the study.
    • Your general health and daily activity level must be good, rated as 0 or 1 on the ECOG scale (a system that measures how cancer affects your daily living abilities).
    • Your expected survival must be at least 6 months.
    • Your cancer must be confirmed by laboratory examination of tissue or cells, and it must be recurrent (came back after treatment) or metastatic (spread to other parts of the body) squamous cell carcinoma (a type of cancer) located in the mouth, throat, lower throat, or voice box area.
    • If your cancer is in the throat area, you must have a test result showing whether your cancer is related to HPV (human papillomavirus, a virus that can cause certain cancers).
    • You must not have received any previous systemic treatment (treatment affecting the whole body) for your recurrent or metastatic cancer. However, you may have received previous chemotherapy, radiation, or other treatments if your cancer came back more than 6 months after those treatments ended.
    • You must have at least one tumor that can be measured using imaging scans, and this tumor must be suitable for repeated measurements to track changes.
    • Your tumor must test positive for a protein called PD-L1 (a protein found on some cancer cells) with a score of at least 1, confirmed by a laboratory test on your tumor tissue sample.

Who cannot join the trial?

3 criteria

  • The source data does not provide specific exclusion criteria for this clinical trial
  • Exclusion criteria are reasons why someone cannot join a study, but this information was not included in the available trial details
  • To learn what conditions or situations would prevent participation in this study, you would need to review the complete trial documentation
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Investigated drugs

  • Ivonescimab

    is an investigational medication being studied in this trial. It is being tested either alone or in combination with another medication to treat head and neck cancer that has spread or come back.

  • Ligufalimab

    is an investigational medication being studied in combination with ivonescimab. It is being tested to see if adding it to ivonescimab improves treatment outcomes for head and neck cancer.

  • Pembrolizumab

    is a medication used as the standard treatment for head and neck cancer. In this trial, it serves as the comparison treatment to see if the investigational medications work better.

What is already known about the treatment

  • Ivonescimab

    Ivonescimab is an investigational medication currently being studied in clinical trials for treating recurrent or metastatic head and neck cancer that has spread or returned after previous treatment. It is administered through injection into a vein and works by blocking specific proteins on cancer cells and immune cells, helping the body's immune system recognize and attack cancer cells more effectively. This drug belongs to a class of medications called immune checkpoint inhibitors, which are designed to enhance the natural ability of the immune system to fight cancer. In this clinical trial, it is being tested alone and in combination with another medication to determine if it can help patients live longer compared to standard treatment options.

  • Ligufalimab

    Ligufalimab is an experimental cancer treatment being evaluated in clinical trials for patients with advanced head and neck cancer that has come back or spread to other parts of the body. It is given as an infusion into the bloodstream and functions by targeting and blocking certain checkpoint proteins that prevent immune cells from attacking tumors, thereby boosting the immune system's ability to fight cancer. This medication is classified as an immune checkpoint inhibitor, a type of immunotherapy that helps remove the brakes on the immune system. In this study, it is being combined with ivonescimab to see if the combination provides better results than using pembrolizumab, which is the current standard treatment.

  • Pembrolizumab

    Pembrolizumab is an approved cancer medication widely used in medical practice for treating various types of cancers, including head and neck cancer that has recurred or spread to distant sites in the body. It is administered as an intravenous infusion and works by blocking a protein called PD-1 on immune cells, which allows the body's immune system to better recognize and destroy cancer cells. This drug belongs to a category of treatments known as immune checkpoint inhibitors or immunotherapy agents. In this clinical trial, pembrolizumab serves as the standard treatment comparison to evaluate whether the newer medications ivonescimab and ligufalimab can provide improved survival outcomes for patients.

Investigated diseases

  • Recurrent Squamous Cell Carcinoma of the Head and Neck

    This is a type of cancer that comes back after initial treatment and originates in the flat, thin cells lining the moist surfaces of the head and neck region. These areas include the mouth, throat, voice box, nose, and sinuses. The disease occurs when squamous cells begin to grow abnormally and form tumors. When the cancer is recurrent, it means it has returned after a period of remission following previous treatment. The cancer may reappear in the same location as the original tumor or in nearby tissues.

  • Metastatic Squamous Cell Carcinoma of the Head and Neck

    This is an advanced form of cancer where abnormal squamous cells from the head and neck region have spread to distant parts of the body. The cancer cells travel through the bloodstream or lymphatic system to form new tumors in organs far from the original site. Common areas where this cancer spreads include the lungs, liver, and bones. As the disease progresses, multiple organs may become affected by these secondary tumors. The metastatic form represents a more widespread stage of the disease compared to cancer that remains localized.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522996-27-00Protocol codeGORTEC 2024-04Estimated enrolment700 patientsSponsorGroupe Oncologie Radiotherapie Tete Cou

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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).