AuthorisedTherapeutic exploratory (Phase II)Interventional

A phase II trial evaluating treatment intensification with Ezabenlimab in patients with PD-L1–expressing, locally advanced head and neck squamous cell carcinoma (LA-HNSCC) with minimal residual disease (MRD) as detected by circulating tumor DNA (ctDNA) after curative-intent chemoradiation

This study is investigating a new medication called Ezabenlimab for people with a specific type of head and neck cancer that has spread locally. The main aim is to see if Ezabenlimab can help stop the cancer from returning in patients who still have very small amounts of cancer cells in their body after their initial standard treatment (chemotherapy and radiation). Doctors use a special blood test to find these tiny cancer traces. The study will track how many patients stay cancer-free for two years and also look at side effects, their quality of life, and how the new treatment affects these cancer traces over time. It's a Phase II trial, meaning it's still an early stage of testing this new treatment.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Cliniques Universitaires Saint-Luc

Enrolment target

160

Start

22 Apr 2026

Locally advanced head and neck squamous cell carcinoma (LA-HNSCC)

What is this study about?

This research study is about a type of cancer called locally advanced head and neck squamous cell carcinoma (that's a long name for a specific cancer starting in the moist linings of the head and neck, which has grown into nearby tissues). After patients have their main treatment, which usually involves a combination of chemotherapy and radiation, some may still have tiny, undetectable traces of cancer left in their body. These traces are called 'minimal residual disease' (MRD) and are found using a sensitive blood test looking for 'circulating tumour DNA' (ctDNA).

The study wants to find out if giving an additional treatment called Ezabenlimab can help prevent the cancer from coming back in these patients who have MRD. Ezabenlimab is an investigational drug, meaning it's still being studied to see how well it works and if it's safe. This study is a 'Phase II' trial, which means researchers are checking its effectiveness and looking for side effects in a smaller group of people after initial safety tests have been done.

The main goal is to see how many patients remain free from the cancer returning or getting worse, or from dying, two years after they've been assessed for MRD. Researchers will also carefully monitor any side effects, how the treatment affects your overall wellbeing and quality of life, and how those tiny cancer traces in the blood change over time. This information will help doctors understand if Ezabenlimab could be a good new option for some people with this type of head and neck cancer.

Key takeaways

This study is for head and neck cancer patients who have completed initial treatment.
It aims to test if a new drug, Ezabenlimab, can stop cancer from returning.
Participants must have 'minimal residual disease' (tiny cancer traces) detected by a blood test.
The study will follow participants for at least two years.
It's a Phase II trial, gathering more information on effectiveness and safety.
Quality of life and side effects will be carefully monitored.

Who may be eligible?

To join this study, you would need to be an adult, at least 18 years old. Both men and women can take part.

Crucially, you would have recently finished standard treatment (chemotherapy and radiation) for your head and neck cancer. After this treatment, a special blood test would have shown that you still have tiny amounts of cancer cells remaining in your blood, even if your scans look clear.

There will also be other specific health requirements that your doctor will check to make sure the study treatment is suitable and safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently finished chemotherapy and radiation for head and neck cancer?
Did a special blood test (ctDNA) show tiny traces of cancer cells (MRD) after your treatment?
Are you able to attend regular hospital visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the treatment called Ezabenlimab. This would likely involve regular visits to the hospital or clinic for your treatment and various check-ups. You would have blood tests to monitor for those tiny cancer traces (ctDNA) about every three months, along with other blood tests to check your general health.

Doctors will also regularly ask you about any side effects you might be experiencing. You'll complete questionnaires about your quality of life to see how the treatment impacts your daily living and wellbeing. The study will track your health and whether your cancer returns or progresses for at least two years after your initial assessment when you first showed those minimal cancer traces. The overall duration of your follow-up could extend longer to monitor your long-term health and survival.

Potential risks and benefits

Potential benefits of taking part could include receiving a new experimental treatment that might help prevent your cancer from returning, which is not yet widely available. You would also be closely monitored by a healthcare team. However, there's no guarantee the treatment will work for you. There are potential risks associated with Ezabenlimab, as with any medication, including side effects. These could range from mild to serious, and the research team will explain them in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What is 'locally advanced head and neck squamous cell carcinoma'?

It's a type of cancer that starts in the moist linings of the head and neck, like the throat or mouth, and has grown into nearby tissues.

What does 'minimal residual disease' (MRD) mean?

It means there are very tiny traces of cancer cells left in your body, found with a special blood test, even after your main treatment.

What is Ezabenlimab?

Ezabenlimab is the name of a new study drug being tested to see if it can help prevent cancer from coming back in certain patients.

What is a 'Phase II' clinical trial?

It's an early stage of testing a new treatment on a smaller group of people to see if it works and what its side effects are, after initial safety checks.

Will I definitely get Ezabenlimab if I join?

This particular study design suggests that patients who meet the criteria would receive Ezabenlimab. Your doctor will confirm the exact details of the treatment you would receive.