RecruitingPHASE3INTERVENTIONAL

Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head & Neck Cancers

This study is investigating a new treatment approach for people newly diagnosed with head and neck cancer that has spread. It compares combining radiotherapy (a type of radiation treatment) with a drug called pembrolizumab (a modern immunotherapy drug) – either on its own or alongside chemotherapy – against the current standard treatments. The main goal is to see if these new combinations are more effective at treating the cancer. It's a large, important study involving many hospitals, helping doctors understand the best way to treat this condition and improve patient outcomes.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

UNICANCER

Enrolment target

102

Start

01 Dec 2021

Estimated completion

01 Oct 2029

Squamous Cell Carcinoma of Head and Neck

What is this study about?

This study is for people who have been recently diagnosed with a type of head and neck cancer called squamous cell carcinoma, which has already spread to other parts of the body (this is called metastatic cancer). Doctors are always looking for better ways to treat cancer, and this trial aims to find out if a new combination of treatments is more effective than what’s currently available.

The trial is comparing different treatment approaches. One group of patients will receive radiotherapy (a common cancer treatment using high-energy rays) along with a medication called pembrolizumab. Pembrolizumab is an immunotherapy drug that works by helping your body's own immune system fight cancer. Some patients in this group might also receive chemotherapy, which are drugs that kill cancer cells. These combinations will be compared against the standard treatments that patients would usually receive for this type of cancer.

This is a 'Phase 3' study, which means it’s one of the final steps before a new treatment might become widely available. These studies involve many patients and are designed to confirm how well a treatment works and its safety. By taking part, you could help doctors learn more about the best ways to treat head and neck cancer, potentially helping many people in the future.

Key takeaways

Tests new cancer treatment combinations.
For advanced head and neck cancer, newly diagnosed.
Compares radiotherapy + pembrolizumab (with/without chemo) to standard care.
Aims to find more effective treatments.
Participation is voluntary; you can withdraw anytime.

Who may be eligible?

To join this study, you must first agree to take part and sign a consent form. It's for adults, aged 18 or over. You need to have been recently diagnosed with squamous cell head and neck cancer that has spread to other parts of your body. Doctors will need to confirm your cancer diagnosis with a biopsy.

You also need to be generally well enough to take part, as assessed by your doctor. This includes having good overall health, and your blood tests must show that your liver, kidneys, and blood cells are working properly. Your cancer also needs to be visible enough on scans for doctors to measure if the treatment is working. Finally, if you are able to become pregnant, you must agree to use effective contraception during the study and for several months afterwards.

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 been newly diagnosed with head and neck squamous cell cancer that has spread?
Are you generally well enough for cancer treatment?
Do you have good kidney, liver, and blood test results?
Are you willing to use contraception if you could become pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of the treatment groups, like flipping a coin. You will receive either the combination of radiotherapy and pembrolizumab (with or without chemotherapy) or the standard treatment for your cancer. This means you won’t get to choose which specific treatment you receive.

Throughout the study, you will have regular hospital visits, scans, and blood tests to monitor your health and how the treatment is working. Your doctors will explain the schedule for your specific treatment. The total duration of your active treatment will depend on the plan for your group, and there will be follow-up appointments after your main treatment has finished to check on your long-term health. The exact number of visits, tests, and total time involved will be explained by the study team.

Potential risks and benefits

Taking part in a clinical trial can offer potential benefits, such as access to new and potentially more effective treatments before they are widely available. Your health will also be closely monitored by a dedicated team. However, there are also potential risks; you might experience side effects from the treatments, some of which could be serious, and the new treatments might not work for you. The study team will explain all known side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (26)

Institut Sainte Catherine
Verified postcode
Avignon, France· Recruiting
CHU Jean Minjoz
Verified postcode
Besançon, France· Recruiting
CHU Bordeaux
Verified postcode
Bordeaux, France· Recruiting
Institut Bergonié
Verified postcode
Bordeaux, France· Recruiting
Centre François Baclesse
Verified postcode
Caen, France· Recruiting
CH Carcassonne
Verified postcode
Carcassonne, France· Recruiting
Centre Jean Perrin
Verified postcode
Clermont-Ferrand, France· Recruiting
Centre Georges François Leclerc
Verified postcode
Dijon, France· Recruiting
Centre Guillaume le Conquérant
Verified postcode
Le Havre, France· Suspended
Centre Jean Bernard - Clinique Victor Hugo
Verified postcode
Le Mans, France· Recruiting
Centre Oscar Lambret
Verified postcode
Lille, France· Recruiting
Groupe Hospitalier Bretagne Sud
Verified postcode
Lorient, France· Recruiting

Common questions

What type of cancer is this study for?

This study is for a specific type of head and neck cancer called squamous cell carcinoma, which has spread to other parts of the body.

What are the main treatments being tested?

The study is testing radiotherapy combined with a drug called pembrolizumab, sometimes with chemotherapy, against standard treatments.

Who can join the study?

Adults aged 18 and over, newly diagnosed with this type of cancer and generally well, may be considered.

Will I get to choose my treatment?

No, if you join, you will be randomly assigned to one of the treatment groups by chance, like drawing a name from a hat.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, and it won't affect your regular medical care.

How to find out more

NICOLAS DE SOUSA CARVALHO

n-de-sousa@unicancer.fr 0171936709 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.