Active not recruitingPHASE1INTERVENTIONAL

A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer

This study is for adults with a specific type of head and neck cancer where previous treatments haven't worked well, or there are no standard treatments available. It's looking for better ways to make tumours shrink by combining several new medicines. These medicines work in different ways: some help your body's immune system fight cancer, others block signals that make cancer grow, and one stops new blood vessels from forming that tumours need. All participants in this study will receive a combination of three specific medicines, given through a drip, and will be carefully monitored by doctors. The main goal is to see if these combinations can help more people tackle their cancer effectively.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Boehringer Ingelheim

Enrolment target

Start

12 Apr 2022

Estimated completion

31 Jul 2026

Head and Neck Squamous Cell Carcinoma (HNSCC)

What is this study about?

This study is investigating new treatment options for adults diagnosed with a specific type of head and neck cancer, especially if their previous treatments haven't been successful or if there are no standard treatment choices left. The main aim is to discover if combining several new medicines can make tumours shrink more effectively.

The medicines being tested are a type of drug called "antibodies." These are specially designed to target cancer in different ways. Some, like BI 765063 and Ezabenlimab, are designed to boost your body's own immune system to fight the cancer – they're sometimes called 'checkpoint inhibitors'. Another medicine, Cetuximab, works by blocking specific growth signals that cancer cells use to multiply. Lastly, BI 836880 aims to stop new blood vessels from forming, which tumours need to grow and spread.

Currently, all participants in this study will receive a combination of three specific drugs: BI 765063, Ezabenlimab, and Cetuximab. The doctors involved will carefully watch how these combinations affect the cancer and your overall health. This approach hopes to find a more powerful way to treat this type of cancer than current methods.

Key takeaways

This study explores new drug combinations for head and neck cancer.
It's for people whose previous treatments weren't successful.
New medicines aim to boost immune response and stop cancer growth.
Participants will receive a combination of three drugs via infusions.
Regular visits and health monitoring are part of the process.
You can withdraw from the study at any time.

Who may be eligible?

This study is for adults, aged 18 or older, who have been diagnosed with head and neck cancer. It's important that your general health is good enough to take part, meaning you can look after yourself most of the time and have a life expectancy of at least three months.

You'll also need to have at least one tumour that can be measured by doctors, and you must agree to provide tissue samples (biopsies) from your tumour before and during the study, unless there's a medical reason why you can't. Women who could become pregnant must agree to use effective contraception during and for six months after the study.

One specific requirement is that your blood will be tested to check a particular gene marker (called SIRPα V1/V1 genotype). This is because the new medicines might work better for people with this specific gene type. Your doctor will discuss all these points with you to see if this study could be right for you.

Quick self-check

Are you 18 years old or older?
Do you have head and neck cancer?
Has your previous treatment not worked well, or are there no standard options left?
Do you have a tumour that doctors can measure?
Are you willing and able to provide tumour tissue samples (biopsies)?
Is your general health good enough that you are mostly active and capable?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll receive the study medicines through an infusion (a drip into your vein). BI 765063, Ezabenlimab, and BI 836880 are given every three weeks, while Cetuximab is given every one or two weeks. You can continue to be part of the study for as long as the treatment is helping you and you are feeling well enough to continue, up to a maximum of two years for some of the treatments.

You'll need to visit the study site regularly. During these visits, doctors will check your general health, monitor for any side effects, and keep track of your tumour's size to see how it's responding to the treatment. They will also take blood tests and may collect other samples to learn more about how the medicines are working.

Potential risks and benefits

Participating in this study might offer you a chance to try a new combination of medicines that could help shrink your tumour, especially if other treatments haven't worked. However, like all medicines, these drugs can have side effects, and there's no guarantee the treatment will work for everyone. The study team will carefully monitor your health and any unwanted effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (25)

Valkyrie Clinical Trials
Los Angeles, United States
CTR Georges-François Leclerc
Dijon, France
CTR Leon Berard
Lyon, France
HOP Timone
Marseille, France
INS Curie
Paris, France
HOP Civil
Strasbourg, France
INS Claudius Regaud IUCT-Oncopole
Toulouse, France
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, Japan
Hospital Sultan Ismail
Johor Bahru, Malaysia
Sarawak General Hospital
Kuching, Sarawak, Malaysia
ARKE SMO S.A. de C.V
Mexico City, Mexico
FAICIC S de RL de C.V.
Veracruz, Mexico

+13 more sites — see the official record for the full list.

Common questions

What kind of cancer is this study for?

This study is specifically for adults with a type of head and neck cancer called Head and Neck Squamous Cell Carcinoma (HNSCC).

What if I've had treatment before?

This study is designed for people whose previous treatments weren't successful, or for whom there are no standard treatments available.

How are the medicines given?

All the study medicines are given as infusions, which means they are delivered through a drip into your bloodstream.

How long will I be in the study?

You can stay in the study as long as the treatment is benefiting you and you can tolerate it. Some specific treatments in the combination are given for no longer than two years.

What is the main goal of the study?

The main goal is to see if combining these new drugs can make tumours shrink more effectively in people with head and neck cancer.