Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

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 research study is investigating new treatments for people with advanced head and neck cancer (specifically squamous cell carcinoma) or liver cancer (hepatocellular carcinoma). Doctors are testing several new medicines, BI 765063, ezabenlimab, and BI 836880, sometimes combined with standard chemotherapy or another drug called cetuximab. The main goal is to find out if these different combinations are safe and if they can help shrink tumors or stop the cancer from growing. This is an early-stage study, meaning we're still learning how these new combinations work in people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

23 Jul 2024

hepatocellular carcinoma, head and neck squamous cell carcinoma (HNSCC)

What is this study about?

This study is an important step in finding better ways to treat advanced head and neck cancer and liver cancer. These types of cancer can be challenging, and doctors are always looking for new treatments that might be more effective or have fewer side effects than current options.

The researchers are testing several new medications that work in different ways to fight cancer. Some of these drugs might help your own body's immune system recognize and attack cancer cells, while others might directly target the cancer cells themselves. By trying different combinations of these new drugs with existing treatments like chemotherapy or cetuximab, the study aims to see if they can work together more powerfully against the cancer.

Because this is an early-stage study, it means that while these treatments have been tested in laboratories, this is one of the first times they're being used in different combinations in people. The main purpose is to understand if these combinations are safe and if they show any promising signs of fighting the cancer. Your participation could help doctors learn crucial information that might lead to new treatments for many people in the future.

Key takeaways

This study explores new treatment combinations for advanced head and neck or liver cancer.
It's an early-stage study focusing on safety and initial effectiveness.
Potential treatments include new drugs, chemotherapy, or cetuximab.
Participation involves regular hospital visits for tests and monitoring.
You'll receive close medical attention throughout the study.
You can stop participating at any time without affecting your standard care.

Who may be eligible?

To join this study, you generally need to be an adult, 18 years old or older. The study is open to both men and women. You would need to have been diagnosed with either advanced hepatocellular carcinoma, which is a common type of liver cancer, or advanced head and neck squamous cell carcinoma.

Beyond these basic requirements, doctors will also check other things about your health and your specific cancer to make sure the study is a good fit for you. This is to ensure your safety and that the study results are as clear as possible. For example, they'll look at your overall health and how well your body's organs, like your kidneys and liver, are working.

It's important to remember that not everyone with these types of cancer will be able to join. There are specific medical criteria that your doctor will review carefully with you. This isn't because anyone is being excluded, but because the researchers need to make sure they are testing the treatments in the most appropriate and safest group of people.

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 diagnosed with advanced hepatocellular carcinoma (liver cancer)?
Or have you been diagnosed with advanced head and neck squamous cell carcinoma?
Are you able to travel to study appointments regularly?
Are you generally well enough to take part in a clinical study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a number of tests. These tests are to ensure you meet all the health requirements for the study. If you qualify, you would receive the study medication (which could be a combination of new drugs and/or existing treatments) for a period of time. This medication might be given as an injection, through a drip (intravenous infusion), or as tablets.

Throughout the study, you would come to the hospital or clinic regularly for check-ups. These visits will involve blood tests, physical examinations, and possibly scans (like CT or MRI scans) to monitor your health and see how the treatment is affecting your cancer. The frequency of visits might change over time, being more frequent at the beginning and then less often later on.

There will also be a follow-up period after you finish receiving the study treatment, where doctors will continue to monitor your health and the long-term effects of the treatment. The total duration of your participation, including treatment and follow-up, can vary greatly depending on how your body responds to the treatment and the specific combination you are receiving. Your study doctor will explain the expected timeline for you.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of joining this study is that you might receive new treatments that are not yet widely available and could potentially help fight your cancer more effectively. You would also receive very close medical attention and monitoring from a team of specialists. However, there's always a possibility that the treatments might not work for you, or they might cause side effects. These side effects can range from mild to more serious, and the research staff will explain all known and possible side effects to you. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
France
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Unverified
Romania
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Unverified
Spain

Common questions

What is a 'human pharmacology' or 'Phase I' study?

This is an early-stage study primarily to check if a new treatment or combination of treatments is safe and what dose works best in people. It also helps us understand how the drugs work in the body.

Will I know which treatment I'm getting?

In this type of study, you will likely know which combination of medicines you are receiving. The study is testing specific combinations rather than comparing to a placebo (a dummy drug).

What if the treatment isn't working for me?

Your doctors will regularly monitor your health and your cancer. If the treatment isn't working or if you experience severe side effects, your participation in the study might be stopped, and your doctors will discuss other treatment options with you.

Will I have to pay to be part of the study?

No, you will not have to pay for the study drugs or medical appointments that are directly related to the research. You might be reimbursed for travel expenses related to your study visits.

Who can I talk to if I have more questions?

You should discuss any questions or concerns with your own doctor first. If they think the study might be suitable, they can refer you to the research team who can provide detailed information and answer all your questions.