Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A double-blind randomized, Phase III study of radiotherapy combined with cetuXimab + Xevinapant compared to radiotherapy combined with cetuximab (Standard of care) + placebo in patients with Locally advanced (LA) squamous cell carcinoma of the head and neck (SCCHN), unfit for high-dose cisplatin (XXL study)

This research study is looking at a new treatment approach for a type of head and neck cancer that is quite advanced. This cancer is called 'locally advanced squamous cell carcinoma of the head and neck,' or LA SCCHN. The study is comparing a new drug, xevinapant, when given alongside the usual treatment (radiotherapy and cetuximab), to see if it's more effective. The usual treatment with radiotherapy and cetuximab is known as the standard care. Participants will receive either xevinapant or a dummy drug (placebo) in addition to their standard treatment, without knowing which they are getting. The main goal is to find out if adding xevinapant helps patients live longer without their cancer worsening. We will also look at how long people live overall and what side effects might occur.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Groupe Oncologie Radiotherapie Tete Cou

Enrolment target

377

Start

08 Aug 2023

Locally advanced squamous cell carcinoma of the head and neck

What is this study about?

This study is for people with a specific type of cancer called 'locally advanced squamous cell carcinoma of the head and neck,' often shortened to LA SCCHN. 'Locally advanced' means the cancer has grown into nearby tissues or lymph nodes, but hasn't spread to distant parts of the body. Unfortunately, for various health reasons, some patients with this type of cancer cannot have intense chemotherapy with a drug called cisplatin.

Currently, the standard treatment for these patients is a combination of radiotherapy (targeted radiation to kill cancer cells) and a drug called cetuximab. This study wants to see if adding a new drug, xevinapant, to this standard treatment can make it even better. Xevinapant is an investigational drug, meaning it's still being studied, and isn't yet a standard treatment. Half of the participants will receive xevinapant alongside their standard treatment, while the other half will receive a 'placebo,' which looks like xevinapant but has no active ingredients. This helps researchers fairly compare the new drug's effects.

The main question we hope to answer is whether adding xevinapant helps patients live longer without their cancer getting worse. This is called 'progression-free survival.' We will also be carefully monitoring how long people live overall and what side effects they experience. Finding new, more effective, and manageable treatments is very important for patients with this challenging form of cancer.

Key takeaways

This study evaluates a new drug (xevinapant) for advanced head and neck cancer.
It aims to see if xevinapant improves how long patients live without their cancer worsening.
Participants will receive either xevinapant or a placebo, in addition to standard treatment.
Open to adults aged 18 and over, of any sex, who cannot tolerate high-dose cisplatin.
You will be closely monitored for treatment effects and side effects.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you must have locally advanced squamous cell carcinoma of the head and neck. This means your cancer has spread locally but not to distant parts of your body. An important requirement is that your doctors believe you are not healthy enough to receive high-dose cisplatin, which is a strong chemotherapy drug often used for this type of cancer. This decision would be made by your medical team based on your overall health.

Participants must be at least 18 years old, and there is no upper age limit. The study is open to both men and women. Your doctors will perform tests to confirm your cancer type and stage, and to ensure you meet all the necessary health criteria for participating safely in the study.

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.

Do I have locally advanced squamous cell carcinoma of the head and neck?
Has my doctor said I cannot receive high-dose cisplatin chemotherapy?
Am I at least 18 years old?
Am I able to attend regular clinic visits and follow the treatment plan?
Am I open to the possibility of receiving a placebo instead of the new drug?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be randomly assigned to one of two groups: either receiving xevinapant alongside your standard treatment (radiotherapy and cetuximab), or receiving a placebo with your standard treatment. Neither you nor your doctor would know which group you are in. You will receive your treatment according to a specific schedule, which will involve regular visits to the clinic for your radiotherapy and cetuximab infusions, as well as taking the xevinapant or placebo.

You would have regular check-ups, blood tests, and scans to monitor your health, how the treatment is affecting your cancer, and to check for any side effects. These assessments will continue for a period after your main treatment ends to see how you are doing in the long term. The total duration of your participation, including follow-up, will be explained in detail by the study team, but it will involve consistent monitoring over several months to years.

Potential risks and benefits

Participating in a clinical trial may offer the potential benefit of accessing a new, experimental treatment that isn't yet widely available, which might improve your condition. However, there's no guarantee that the new drug, xevinapant, will be effective for you, and it could also cause side effects that are currently unknown or more severe than those from standard treatment. You will be closely monitored for any side effects. There are also risks associated with the standard treatments themselves (radiotherapy and cetuximab). You have the right to withdraw from the study at any time, for any reason, without it affecting your future 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
France

Common questions

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

It's a type of cancer that has grown into nearby tissues or lymph nodes in your head or neck area, but hasn't spread to distant parts of your body.

What does a 'double-blind' study mean?

It means neither you nor your doctors will know if you are receiving the new drug (xevinapant) or the dummy drug (placebo) along with your regular treatment. This helps make the study fair.

What is 'progression-free survival'?

It's how long you live without your cancer getting worse or coming back. It's an important way to measure if a treatment is working.

What is a 'placebo'?

A placebo is a dummy drug that looks like the real drug but contains no active ingredients. It's used in studies to compare the effects of the actual drug against no active treatment.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it will not affect your future medical care.