Active not recruitingPHASE3INTERVENTIONAL

Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer

This study is for people with head and neck cancer that has returned or spread and has already been treated with certain other therapies. Doctors want to find out if a new drug called Monalizumab, when given alongside Cetuximab, is a better treatment option than Cetuximab alone with a dummy drug (placebo). Half of the participants will receive Monalizumab and Cetuximab, and the other half will receive Cetuximab and a placebo. This is a "double-blind" study, meaning neither the participants nor their doctors will know which treatment they are getting. Safety and effectiveness will be carefully checked throughout the study. The aim is to see if this new combination can help people with this type of cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

370

Start

02 Oct 2020

Estimated completion

24 Sep 2026

Squamous Cell Carcinoma of the Head and Neck

Results

Results from this study

Posted November 2023

Results have been published for this study.

Primary outcome

Overall Survival (OS) in Human Papillomavirus (HPV)-Unrelated Analysis Set

The OS is defined as time from the date of randomization until death due to any cause regardless of whether the participant withdraws from randomized therapy or receives another anti-cancer therapy (i.e. date of death or censoring - date of randomization + 1). The OS was analyzed using Kaplan-Meier technique. Statistical analysis was performed using P-value from a stratified log-rank test and hazard ratio (HR) and confidence intervals (CIs) from a stratified Cox proportional hazards model. Analyses were stratified on World Health Organization/ Eastern Cooperative Oncology Group performance status (WHO/ECOG PS) (0 or 1) and number of prior lines of therapy in recurrent or metastatic (R/M) setting (1 or 2).

Full results on the registry

What is this study about?

This study is looking into new ways to treat a type of cancer called squamous cell carcinoma of the head and neck. This is cancer that starts in the flat cells lining parts of the head and neck, like the mouth, throat, or voice box. The study is specifically for people where this cancer has either come back after treatment (recurrent) or has spread to other parts of the body (metastatic).

If you're considering this study, it means you've likely already had some treatments that haven't fully worked, such as certain types of immunotherapy and chemotherapy. The main goal is to see if adding a new drug called Monalizumab to an existing treatment, Cetuximab, is safer and more effective at treating this cancer than Cetuximab combined with a dummy drug, called a placebo.

Finding new and better treatments is really important for people with head and neck cancer that has returned or spread. Studies like this help doctors understand how new drugs work, if they can improve health, and if they are safe for patients. Your participation could help future patients facing similar challenges.

Key takeaways

This study is for head and neck cancer that has come back or spread.
It tests a new drug (Monalizumab) combined with an existing one (Cetuximab).
Participation means receiving either the new combination or Cetuximab with a dummy drug.
The study aims to find safer and more effective treatment options.
You will have regular health checks and close monitoring throughout.

Who may be eligible?

To join this study, people need to be at least 18 years old. They must have head and neck cancer that has come back or spread, specifically affecting areas like the mouth, throat, or voice box. This cancer should also not be curable with standard treatments.

Participants must have already received a type of immunotherapy called a PD-L1 inhibitor, and their cancer should have worsened after platinum-based chemotherapy. They should have had one or two previous treatments for their advanced cancer. Doctors will also need to be able to measure the size of the cancer, and a recent sample of the tumour tissue will be required for testing. Participants should also be generally well enough to take part, with a good overall health score (WHO/ECOG Performance Status of 0 or 1).

There are also some reasons why someone might not be able to join. For example, if your head and neck cancer is not one of the specific types being studied, or if you've already had Cetuximab in certain situations. People with active autoimmune conditions (where the body's immune system attacks healthy cells) or if they are having other cancer treatments at the same time, would also not be able to participate.

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 or older?
Do you have head and neck cancer that has come back or spread?
Have you already had certain immunotherapy and chemotherapy treatments?
Is your health generally good enough for a study?
Do you have a recent sample of your tumour tissue available?

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. Two out of three people will receive Monalizumab plus Cetuximab, while one out of three will receive a placebo (dummy drug) plus Cetuximab. Neither you nor your doctor will know which treatment you are getting. You will receive your treatment for as long as it is working or until any side effects become too strong. You will have regular check-ups and tests throughout the study to monitor your health and how the treatment is affecting you. Even after you stop the main treatment, doctors will continue to follow up on your health to collect important information about long-term effects and survival. The total duration of your participation will depend on how you respond to the treatment and the follow-up period, which can be several months or longer.

Potential risks and benefits

Taking part in a clinical trial might offer different benefits. You could be among the first to try a new treatment that might be more effective than current options, and you'll receive careful monitoring of your health. However, there are also potential risks; the new drug might cause side effects, which could be mild or serious, and it might not work for everyone. While the study aims to improve treatment, there's no guarantee the new drug will be better than existing ones, or even better than the placebo. It's important to remember that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (127)

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

Research Site
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Tucson, United States
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Chicago, United States
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Westwood, United States
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Boston, United States
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Ann Arbor, United States
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Rochester, United States
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St Louis, United States
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Las Vegas, United States
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New York, United States
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Charlotte, United States
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Winston-Salem, United States
Research Site
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Columbus, United States

Common questions

What is head and neck squamous cell carcinoma?

It's a type of cancer that starts in the flat cells lining certain parts of the head and neck, like the mouth, throat, or voice box.

What does 'recurrent or metastatic' mean?

Recurrent means the cancer has come back after treatment. Metastatic means the cancer has spread to other parts of the body.

What are Monalizumab and Cetuximab?

They are types of targeted drug treatments that work by attacking cancer cells in specific ways.

What is a 'placebo'?

A placebo is a dummy drug that looks like the real treatment but contains no active medicine. It helps doctors see if the new drug is truly effective.

Will I know which treatment I'm getting?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know if you are receiving the new drug or the placebo.