Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A randomized, double-blind, placebo-controlled, 2-arm Phase III study to assess efficacy and safety of xevinapant and radiotherapy compared to placebo and radiotherapy for demonstrating improvement of disease-free survival in participants with resected squamous cell carcinoma of the head and neck, who are at high-risk for relapse and are ineligible for high-dose cisplatin

This research study is for people who have had a type of head and neck cancer removed by surgery. This cancer is called squamous cell carcinoma. The study is for those at a higher risk of their cancer coming back, and who can't have a common chemotherapy drug called cisplatin. We want to see if adding a new trial medicine, xevinapant, to standard radiotherapy treatment works better than radiotherapy with a dummy medicine (placebo) to stop the cancer from returning. By comparing these two groups, we hope to understand if xevinapant can improve how long people stay cancer-free after their surgery and radiotherapy.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Merck Healthcare KGaA

Enrolment target

262

Start

21 Feb 2024

Resected squamous cell carcinoma of the head and neck

What is this study about?

This study is about a type of cancer that can start in the head and neck area. If you've had surgery to remove this cancer, and your doctors think there's a higher chance it might return, this study could be for you. It's also for people who can't have a common chemotherapy treatment called cisplatin, which is usually given to help reduce the risk of the cancer coming back.

The main aim of this study is to see if a new medicine, called xevinapant, can help keep the cancer away for longer when given alongside radiotherapy. Radiotherapy is a standard treatment that uses high-energy rays to kill cancer cells. In this study, some people will get xevinapant plus radiotherapy, while others will get radiotherapy plus a dummy medicine (a placebo). A placebo looks just like xevinapant but contains no active medicine.

By comparing what happens in these two groups, doctors hope to find out if xevinapant is effective and safe. This type of study is called a 'Phase III' study, which means it's a large, important step to see if a new treatment should become widely available. The information we gather will help us understand if xevinapant could be a new way to treat head and neck cancer and prevent it from coming back after surgery.

Key takeaways

Study for head and neck cancer after surgery.
Compares new drug (xevinapant) with standard radiotherapy.
Aims to prevent cancer return for high-risk patients.
Includes a dummy medicine (placebo) group for comparison.
For adults unable to receive standard cisplatin chemotherapy.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 or older. Both men and women can take part. You would need to have had surgery to remove a specific type of head and neck cancer.

Crucially, your doctors must also believe that there's a higher chance of your cancer returning. In addition, you must not be able to have a standard chemotherapy treatment called cisplatin, often due to other health reasons or how your body handles medicines.

There will be other detailed health checks to make sure this study is right and safe for you. Your medical team will go through all the specific requirements with 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 had surgery for squamous cell carcinoma of the head and neck?
Do your doctors think there's a high risk your cancer could return?
Are you unable to have cisplatin chemotherapy?
Are you available for regular hospital visits and follow-up checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be assigned to one of two groups by chance, like flipping a coin. One group will receive the new medicine, xevinapant, along with standard radiotherapy. The other group will receive a dummy medicine (placebo) with standard radiotherapy. Neither you nor your doctors will know which group you are in.

Taking part would involve regular visits to the hospital for your treatment and to have various checks, tests, and scans. These are to monitor your health, how you are responding to the treatment, and to check for any side effects. You will be given the study medication in cycles, and overall, this study will involve regular follow-up for a significant period to track your long-term health.

The total length of time you are actively taking the study drug and having frequent assessments will be explained to you in detail, but ongoing follow-up will continue for several years to understand the long-term effects of the treatments.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a new experimental treatment that could be more effective in preventing your cancer from returning. However, there's also a chance you might receive the dummy medicine. Like all treatments, xevinapant may have side effects, which could range from mild to serious, and your medical team will monitor you closely for these. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care or your relationship with your healthcare team.

Locations (12)

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

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Unverified
Greece
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Unverified
Austria
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Unverified
Belgium
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Unverified
Spain
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Unverified
Czechia
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Unverified
Portugal
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Unverified
Poland
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Unverified
Romania
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Unverified
Italy
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Unverified
France
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Unverified
Netherlands
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Unverified
Germany

Common questions

What is head and neck squamous cell carcinoma?

It's a type of cancer that starts in the flat, scale-like cells in the moist lining of the head and neck, such as the mouth, throat, or voice box.

What does 'randomised' mean in a study?

It means you are assigned to a treatment group by chance, like drawing straws. This helps make the study fair and unbiased.

What is a 'placebo'?

A placebo is a dummy medicine that looks exactly like the study drug but contains no active ingredients. It helps researchers fairly compare the new drug's effects.

Will I know if I'm getting xevinapant or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know which treatment you are receiving until after the study is complete, unless there's an emergency.

What is 'Disease-Free Survival'?

This refers to the length of time after treatment that a patient lives without the cancer returning or getting worse.