RecruitingPHASE3INTERVENTIONAL

A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy

This research is looking at a new medicine called volrustomig for people who have a specific type of head and neck cancer. This cancer is locally advanced, meaning it’s grown in the area but hasn’t spread to other parts of the body, and it wasn't removed with surgery. Participants in the study have already completed their main treatment, which includes chemotherapy combined with radiotherapy. The main goal is to find out if volrustomig is effective and safe in helping to stop the cancer from getting worse or coming back, compared to just regular check-ups. The study will carefully watch how participants respond to the medicine and check for any side effects.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

1,145

Start

14 Dec 2023

Estimated completion

12 Sep 2030

Locally Advanced Head and Neck Squamous Cell Carcinoma

What is this study about?

This study is about a type of cancer that starts in the head or neck area, specifically called 'squamous cell carcinoma.' This cancer is considered 'locally advanced,' which means it has grown into nearby tissues but hasn't spread to other distant parts of the body. For these patients, the standard treatment often involves a combination of chemotherapy and radiotherapy, given together. This treatment is called 'chemoradiotherapy' and is given with the aim of curing the cancer.

The researchers want to see if adding a new medicine, called volrustomig, to the treatment plan can help. After patients have finished their initial chemoradiotherapy treatment and if their cancer hasn't progressed (meaning it hasn't gotten worse), they might be eligible to join this study. The study will compare volrustomig to simply observing patients, which means they would have regular check-ups without taking the new medicine.

The main purpose is to find out two things: first, how well volrustomig works to prevent the cancer from returning or getting worse, and second, whether it is safe to use. This information will help doctors understand if volrustomig could be a useful new treatment option for people with this type of head and neck cancer.

Key takeaways

This study tests a new medicine for certain head and neck cancers.
It's for people who've completed standard chemotherapy and radiotherapy.
The goal is to see if the new medicine stops cancer from returning.
You might receive the new medicine or have observation.
Regular visits and checks are part of participating.

Who may be eligible?

To be part of this study, you must have a specific type of head and neck cancer known as 'squamous cell carcinoma.' This cancer needs to be in certain areas like the throat, voice box, or inside of the mouth, and it should be 'locally advanced,' meaning it hasn't spread to other parts of your body. Importantly, the hospital doctors must have confirmed that your cancer could not be removed by surgery.

You also need to have already finished your main treatment for this cancer, which involved a combination of chemotherapy and radiotherapy at the same time. The goal of that treatment would have been to cure your cancer, and your cancer should not have gotten worse since then.

There are also reasons why you might not be able to join. For example, if your head and neck cancer started in other areas not listed, or if you had more than one main cancer. You also can't join if your cancer was removed by surgery before your chemotherapy and radiotherapy, or if your cancer has come back or was only treated with radiotherapy alone.

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 you have locally advanced squamous cell carcinoma of the head or neck?
Was your cancer in the throat, voice box, or inside the mouth?
Did you complete combined chemotherapy and radiotherapy for your cancer?
Has your cancer not gotten worse since your main treatment?
Was your cancer treated without surgery first?
Are you 18 years old or older?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first go through some checks to make sure you're eligible. If you are, you would then start receiving the study medicine, volrustomig, or be in the observation group. This medicine is given as a drip into your arm (intravenous infusion). The study involves regular visits to the clinic for assessments, which will include blood tests, scans, and physical examinations to see how you are responding to the treatment and to check for any side effects. You will be closely monitored by the study team. The total duration of your participation in the study, including the treatment and follow-up period, will be explained in detail by the study doctor.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of joining this study could be that the new medicine, volrustomig, might help prevent your cancer from returning or progressing. However, there's no guarantee this will happen. As with all medicines, volrustomig may cause side effects, and these will be carefully monitored by the study team. You will be given detailed information about these possible side effects. It's very important to remember that you can decide to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (305)

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

Research Site
Verified postcode
Birmingham, United States· Recruiting
Research Site
Verified postcode
Phoenix, United States· Recruiting
Research Site
Verified postcode
Prescott Valley, United States· Suspended
Research Site
Verified postcode
Springdale, United States· Withdrawn
Research Site
Verified postcode
Fountain Valley, United States· Recruiting
Research Site
Verified postcode
Los Angeles, United States· Suspended
Research Site
Verified postcode
Orange, United States· Withdrawn
Research Site
Verified postcode
San Francisco, United States· Suspended
Research Site
Verified postcode
Santa Rosa, United States· Recruiting
Research Site
Verified postcode
Whittier, United States· Recruiting
Research Site
Verified postcode
Aurora, United States· Recruiting
Research Site
Verified postcode
Colorado Springs, United States· Recruiting

Common questions

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

This is a type of cancer that starts in the head or neck, like in the throat or mouth. 'Locally advanced' means it has grown into nearby tissues but hasn't spread to distant parts of the body.

What is 'chemoradiotherapy'?

This is a standard way to treat some cancers, where chemotherapy drugs (strong medicines to kill cancer cells) and radiotherapy (using high-energy rays) are given at the same time.

What is volrustomig?

Volrustomig is the new medicine being tested in this study. Researchers want to see if it can help prevent cancer from coming back after standard treatment.

Will I definitely get the new medicine?

No, not everyone will get the new medicine. Some participants will receive volrustomig, while others will be in an 'observation' group, meaning they will have regular check-ups without the study medicine.

How long does the study last?

The total time you spend in the study, including treatment and follow-up, will be explained by the study doctor, as it can vary for each person.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

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