Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Participants With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor

This research study is for adults with a type of head and neck cancer called squamous cell carcinoma. This is for people whose cancer has returned after treatment or has spread to other parts of the body, and who have already received a specific type of treatment called an immune checkpoint inhibitor. The aim of the study is to test a new drug called monalizumab. Participants will either receive monalizumab with cetuximab, or a placebo (a dummy drug) with cetuximab. Researchers want to find out if monalizumab, when added to cetuximab, can help people live longer compared to cetuximab alone. They will also look at how long people live without their cancer getting worse, how many people respond to the treatment, and their quality of life, alongside other health checks.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

AstraZeneca AB

Enrolment target

Start

27 Jun 2024

Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor

What is this study about?

This clinical trial is designed for people who have squamous cell carcinoma of the head and neck. This is a common type of cancer that starts in the flat cells lining the moist surfaces inside the head and neck. The study is specifically for patients whose cancer has either come back after initial treatment (recurrent) or has spread to other parts of the body (metastatic). It's also important that they have already been treated with a different type of medication called an immune checkpoint inhibitor. These are drugs that help your body's own immune system fight cancer.

The main goal of this study is to see if adding a new drug called monalizumab to an existing treatment, cetuximab, can help people with this condition live longer. Cetuximab is a commonly used drug for this type of cancer. Half of the participants will receive monalizumab plus cetuximab, and the other half will receive a 'placebo' (a dummy drug that looks like monalizumab but contains no active medicine) plus cetuximab. This comparison helps researchers understand if monalizumab is truly effective.

Researchers will carefully monitor participants to see how long they live, how long it takes for the cancer to show signs of growing again, and whether their tumours shrink. They will also collect information on how people feel and how their symptoms change, using questionnaires. Blood tests will be done to check drug levels and look for signs of the body reacting to the drug. All of this information helps determine if monalizumab is a safe and effective treatment option for this group of patients.

Key takeaways

This study is for specific head and neck cancer patients.
It tests a new drug, monalizumab, combined with cetuximab.
The main goal is to see if it helps people live longer.
You might receive the new drug or a dummy drug (placebo).
Close medical monitoring and regular hospital visits are involved.

Who may be eligible?

This study is looking for adults aged 18 and over, of any gender. To be considered for this trial, you must have a specific type of head and neck cancer called squamous cell carcinoma that has either come back or has spread to other parts of your body.

Another very important requirement is that you must have already been treated with a type of medication called an immune checkpoint inhibitor. This means your doctors will need to confirm that you’ve had this specific type of treatment in the past for your cancer. There will also be other medical checks and criteria that your study doctor will discuss with you to make sure it's safe for you to take part.

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.

I am 18 years old or older.
I have been diagnosed with squamous cell carcinoma of the head and neck.
My cancer has either come back or spread to other parts of my body.
I have previously received treatment with an immune checkpoint inhibitor.
I am able to attend regular hospital appointments for treatment and check-ups.

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of two groups: one group will receive monalizumab with cetuximab, and the other will receive a placebo (dummy drug) with cetuximab. You, your family, and the study team will not know which group you are in. Both drugs will likely be given directly into a vein (intravenously). You will have regular hospital visits to receive your study medication, have physical exams, blood tests, and scans to check your health and how your cancer is responding. You will also fill out questionnaires about how you are feeling and any changes in your symptoms. The study will continue for as long as the treatment is helping you and you are tolerating it well, with regular follow-up appointments after you stop active treatment. The total duration for each individual will vary, but will involve a commitment to attend all scheduled appointments.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available, and close monitoring of your health. However, there are also potential risks, including side effects from the study drugs. Monalizumab, cetuximab, and the placebo could cause side effects, some of which may be serious. The study team will explain these in detail. It's important to remember that you can stop participating in 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
Germany

Common questions

What is squamous cell carcinoma of the head and neck?

It's a type of cancer that starts in the flat, scale-like cells that line the moist surfaces inside your head and neck, like the mouth, throat, and voice box.

What does 'recurrent or metastatic' mean?

'Recurrent' means the cancer has come back after treatment. 'Metastatic' means the cancer has spread from where it started to other parts of the body.

What is an 'immune checkpoint inhibitor'?

It's a type of cancer drug that helps your body's own immune system find and fight cancer cells more effectively.

What is a 'placebo'?

A placebo is a dummy drug that looks like the real treatment but contains no active medicine. It helps researchers compare the new drug's effects accurately.

Will I know if I'm getting the new drug or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your study doctors will know whether you are receiving monalizumab or the placebo. This helps ensure fair and unbiased results.