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Study of ezabenlimab in patients with locally advanced head and neck cancer who have remaining signs of disease after chemoradiotherapy

Verified siteInvestigationalNo placebo
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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 individuals with locally advanced head and neck squamous cell carcinoma, which is a type of cancer that starts in the squamous cells of the head and neck area. The research is specifically looking at patients whose tumors show high levels of PD-L1, a protein found on some cancer cells that helps them hide from the immune system. The investigation involves patients who have undergone chemoradiotherapy, a combination of chemotherapy and radiation, but still show signs of minimal residual disease. This term refers to a very small amount of cancer cells that remain in the body after treatment, which can be detected through a test for circulating tumor DNA, a method used to find tiny fragments of cancer genetic material in the blood.

The purpose of the study is to evaluate the effectiveness of ezabenlimab, an experimental medication given as an intravenous infusion, which means it is delivered directly into a vein. Participants in the study will receive this treatment to see if it can help prevent the cancer from returning or growing further. During the course of the study, the presence of cancer in the blood will be monitored regularly to track how the body responds to the medication.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>initial assessment</b>

    At the start of the study, a blood test is performed to look for circulating tumor DNA (ctDNA). this is a type of genetic material from cancer cells that travels through the blood. this test identifies minimal residual disease (MRD), which means small amounts of cancer cells may still remain in the body after previous treatments.

  2. Step 2

    <b>ezabenlimab administration</b>

    The medication ezabenlimab is administered as a solution for infusion through an intravenous line, which means it is delivered directly into a vein. the dose provided is 240 mg.

  3. Step 3

    <b>monitoring and follow-up</b>

    The status of circulating tumor DNA (ctDNA) is monitored approximately every 3 months to track changes in the presence of cancer genetic material.

    The progress is monitored over a period of 2 years to evaluate the time until any disease progression (the cancer growing or spreading), recurrence (the cancer returning), or death.

Who can join the trial?

15 criteria

  • You must be at least 18 years old.
  • You must be able to provide written informed consent, which means signing a document that explains the study details and your agreement to participate.
  • Women who are able to become pregnant must have a negative pregnancy test before being assigned to a study group.
  • Women of child-bearing potential and men who can father a child must use highly effective birth control with a failure rate of less than 1% per year. This must be used during the study and for 180 days after the last dose of medicine.
  • Women who are breastfeeding must agree to stop nursing before the first dose of the study treatment and continue to do so until 6 months after the last treatment.
  • You must have a newly diagnosed locally advanced squamous cell carcinoma (a type of cancer) in the mouth, throat, or voice box that has been confirmed by a tissue sample.
  • You must be eligible for curative-intent chemoradiotherapy, which is a combination of chemotherapy and radiation therapy intended to cure the cancer.
  • You must have completed platinum-based chemoradiation, receiving a total radiation dose of 65 to 70 Gy (a unit used to measure radiation) over 6 to 7 weeks.
  • Your cancer must not show progressive disease, meaning the cancer has not grown or spread since your last checkup.
  • Your tumor must have a PD-L1 CPS score of 20 or higher, which is a specific protein marker measured in your tumor tissue.
  • You must be MRD positive, meaning that 6 to 8 weeks after your initial treatment, testing shows detectable ctDNA (small pieces of cancer DNA found in the blood) that suggests microscopic traces of cancer remain.
  • You must have an ECOG Performance Status of 0 to 2, which is a scale used to measure how well you can perform daily activities and your level of physical functioning.
  • You must have adequate organ function, meaning your blood tests show your organs like the liver and kidneys are working correctly.
  • You must have a 12-lead electrocardiogram (ECG), which is a test that records the electrical activity of your heart, that shows no significant problems.
  • If you have a history of hypertension (high blood pressure) or other heart issues, your LVEF (left ventricular ejection fraction, a measurement of how much blood your heart pumps out with each beat) must be 50% or higher.

Who cannot join the trial?

23 criteria

  • You have previously received radiation therapy (using high-energy rays to kill cancer cells), systemic therapy (medicine that travels through the whole body), targeted therapy (medicine designed to attack specific cancer markers), or major surgery for head and neck cancer that was not part of your standard combined treatment.
  • You have a history of pneumonitis (inflammation of the lung tissue) that required steroids (strong anti-inflammatory medicines), or you currently have pneumonitis or interstitial lung disease (a group of disorders causing scarring of lung tissue).
  • You have other active illnesses that are not controlled, such as active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes, ventricular arrhythmia (an irregular heartbeat originating in the lower chambers of the heart), major seizure disorders, spinal cord compression (pressure on the spinal cord), or superior vena cava syndrome (a blockage of the main vein returning blood to the heart).
  • You have experienced Grade 3-4 bleeding (severe or life-threatening bleeding) caused by cancer, or you are at high risk for bleeding because a tumor is touching or growing into a major blood vessel.
  • You have an active autoimmune disease (a condition where the immune system attacks the body) that required systemic treatment (medicine affecting the whole body) within the last 2 years.
  • You have a diagnosed immunodeficiency (a weakened immune system) or are currently taking systemic steroid therapy (medication like prednisone) or other medicines that suppress the immune system.
  • You have not fully recovered from complications or side effects following a major surgery.
  • You have received a tissue or solid organ transplant from another person.
  • You have cirrhosis (permanent scarring of the liver) or unstable liver or bile duct disease, which may include ascites (fluid buildup in the abdomen), encephalopathy (brain dysfunction caused by liver issues), coagulopathy (problems with blood clotting), varices (swollen veins), or jaundice (yellowing of the skin or eyes).
  • You have a history of serious cardiac abnormalities (heart problems) within the last 6 months, such as arrhythmia (irregular heartbeat), cardiomyopathy (disease of the heart muscle), myocarditis (inflammation of the heart muscle), myocardial infarction (heart attack), or issues with heart valves or blood flow.
  • You have a psychiatric or substance abuse disorder (addiction to drugs or alcohol) that would make it difficult to follow the study rules.
  • Your cancer is located in areas other than the throat, voice box, or mouth, such as the nasopharyngeal area (the upper part of the throat behind the nose) or sinuses.
  • You have any social, family, or living situation issues that might prevent you from attending all scheduled follow-up appointments.
  • You are currently receiving other investigational drugs (experimental medicines) or other cancer treatments.
  • You have previously used medicines that target the immune system, specifically anti-PD-1, anti-PD-L1, or anti-PD-L2 agents (medicines that help the immune system find cancer).
  • You have received a live vaccine within the last 30 days.
  • You have a history of allergic reactions to medicines that are chemically similar to the study drug, ezabenlimab.
  • You have been diagnosed with or treated for a different type of cancer within the last 2 years, with some specific exceptions allowed.
  • You are pregnant, breastfeeding, planning to become pregnant, or the father planning to have children during the study period.
  • You have unresolved toxicity (ongoing side effects) of Grade 2 or higher from your previous combined radiation and chemotherapy treatment.
  • You have a known immune deficiency or have tested positive for HIV.
  • You have active Hepatitis B or Hepatitis C (viral infections that affect the liver) or existing liver cirrhosis.
  • You have a known history of active tuberculosis (a serious bacterial infection that usually affects the lungs).
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Investigated drugs

Ezabenlimab is an experimental drug given through an IV drip to help the body's immune system fight against cancer cells.

What is already known about the treatment

Ezabenlimab - This medication is an experimental drug administered as a liquid through an intravenous infusion into a vein. It is currently being studied in clinical trials and is not yet widely available for general medical use. It is being tested to treat certain types of advanced head and neck cancer by helping the body's own immune system recognize and attack cancer cells. This drug works by blocking a specific protein on the surface of cancer cells that normally acts as a shield to hide them from the immune system.

Investigated diseases

Locally advanced head and neck squamous cell carcinoma - This is a type of cancer that starts in the squamous cells, which are the flat cells lining the mouth, throat, and other parts of the head and neck. In the locally advanced stage, the cancer has grown beyond its initial site but has not yet spread to distant parts of the body. The disease can involve the larynx, pharynx, or oral cavity. It may also spread to nearby lymph nodes in the neck. The condition typically progresses as cells multiply uncontrollably and invade surrounding tissues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523575-36-00Estimated enrolment160 patientsSponsorCliniques Universitaires Saint-Luc

sourced from the EU Clinical Trials Register and site verification

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