Active not recruitingPHASE1INTERVENTIONAL

A Study to Test Whether Treatment With BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Helps People With Head and Neck Cancer Compared With Pembrolizumab Alone

This study is looking for adult volunteers in the UK with a type of head and neck cancer called squamous cell carcinoma that has either spread or come back. The main goal is to find out if using a combination of different study medicines can make tumors shrink more effectively than using one medicine (pembrolizumab) by itself. The medicines being tested are BI 770371, pembrolizumab, and cetuximab. These medicines work in different ways to fight cancer, with some helping your body's immune system. Participants will be randomly placed into one of three groups, each receiving a different mix of these medicines. All study medicines are given directly into a vein at the clinic. Doctors will closely monitor your health, check tumor size, and look for any side effects.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Boehringer Ingelheim

Enrolment target

Start

14 May 2025

Estimated completion

31 Aug 2027

Head and Neck Squamous Cell Carcinoma

What is this study about?

This research study is for adults in the UK who have a type of head and neck cancer called squamous cell carcinoma. This is a common type of cancer that can appear in areas like the mouth, throat, or voice box. The study is particularly for people whose cancer has either spread to other parts of the body or has returned after previous treatment and can't be treated effectively by local methods like surgery or radiation.

The main purpose of this study is to explore if combining certain new medications can be more effective at shrinking tumors than using a single medicine. The medicines involved are BI 770371, pembrolizumab, and cetuximab. Pembrolizumab and BI 770371 are designed to help your body's own immune system find and fight the cancer cells. Cetuximab works by blocking signals that cancer cells use to grow. By teaming these medicines up, researchers hope to give the body a better chance to fight the cancer.

Participants will be assigned by chance to one of three different groups. Each group will receive a specific combination of these study medicines, all given as an infusion into a vein. Doctors will carefully watch your progress, check the size of your tumors, and monitor you for any unwelcome effects. You can continue taking part in the study for as long as the treatment seems to be helping you.

Key takeaways

This study is for adults with advanced head and neck squamous cell cancer.
It tests new combinations of medicines to help the body fight cancer.
Participants are randomly assigned to one of three treatment groups.
Medicines are given as drips into a vein at the study clinic.
Doctors will closely monitor health, side effects, and tumor size.
You can leave the study at any time.

Who may be eligible?

This study is for adults with certain types of head and neck squamous cell cancer that has spread or come back. This means your cancer can't be fully treated with surgery or radiation. You must not have had other treatments for your advanced cancer already, though some previous treatments finished a long time ago might be allowed.

There are also some important requirements related to having a tissue sample (biopsy) of your cancer available for the study. You also need to meet specific health criteria, confirmed by your doctor, to ensure it's safe for you to take these study medications. For instance, you should not have any health conditions that would make it unsafe for you to receive pembrolizumab or cetuximab.

However, some conditions might mean you cannot join the study. For example, if your cancer started in the nose or certain other head and neck areas, or if you have certain other health issues, you would likely not be able to participate. Your study doctor can tell you if you meet all the detailed requirements.

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 an adult with head and neck squamous cell cancer that has spread or returned?
Has your cancer been confirmed by a doctor with a tissue sample?
Have you not received prior treatment for your advanced cancer (with some exceptions)?
Are you able to provide a recent or stored tissue sample of your cancer?
Do you meet the overall health requirements for taking these medicines?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance (like flipping a coin) to one of three treatment groups. Each group will receive a different combination of the study medicines (BI 770371, pembrolizumab, with or without cetuximab). All these medicines are given directly into a vein through a drip. You'll visit the study site regularly to receive your treatment and have thorough check-ups. During these visits, doctors will monitor your health, take blood tests, and assess any side effects. They will also regularly check the size of your tumors using scans to see how the treatment is working. You can continue in the study as long as the treatment is helping you and you are tolerating it well. The total duration of your participation will depend on how you respond to the treatment.

Potential risks and benefits

Taking part in this study could offer a potential benefit if the combination therapies prove more effective at shrinking your cancer than current treatments. However, there's no guarantee the treatment will work for you, and it might not help everyone. Like all medicines, the study drugs can have side effects, which could range from mild to serious. The doctors will monitor you very closely for any issues. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (53)

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

Norton Cancer Institute, Downtown
Verified postcode
Louisville, United States
M Health Fairview Clinics and Surgery Center - Minneapolis
Verified postcode
Minneapolis, United States
The Ohio State University Wexner Medical Center
Verified postcode
Columbus, United States
Gosford Hospital
Verified postcode
Gosford, Australia
Andrew Love Cancer Centre
Verified postcode
Geelong, Australia
Hospital de Amor
Verified postcode
Barretos, Brazil
Liga Norte Riograndense contra o cancer
Verified postcode
Natal, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Verified postcode
São José do Rio Preto, Brazil
MBAL Sveta Sofia
Verified postcode
Sofia, Bulgaria
CTR Oscar Lambret
Verified postcode
Lille, France
CTR Leon Berard
Verified postcode
Lyon, France
HOP Timone
Verified postcode
Marseille, France

Common questions

What type of cancer is this study for?

This study is for adults with a specific type of head and neck cancer called squamous cell carcinoma that has spread or returned.

How are the study medicines given?

All the study medicines are given as an infusion (drip) directly into a vein at the study clinic.

Will I know which treatment I am getting?

Because you are assigned to a group by chance, neither you nor your study doctor will decide which specific combination of medicines you receive.

How long will I be in the study?

You can stay in the study as long as the treatment is helping you and you are feeling well enough to continue, and the doctors don't find reasons for you to stop.

What are the main goals of this study?

The main goal is to find out if combining different medicines can shrink head and neck tumors more effectively than one medicine alone.