Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomized, Phase 2, Open-Label, Multi-Arm Study of Tislelizumab in Combination With Investigational Agents as First-Line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This study is researching new ways to treat head and neck squamous cell carcinoma, a type of cancer that affects the head and neck area. It's for people whose cancer has come back or spread to other parts of the body. The study is testing a medicine called Tislelizumab in combination with other new, investigational drugs (BGB-A425 and LBL-007). Researchers want to see how effective these combinations are at shrinking tumours and how safe they are for patients. This is a Phase 2 study, which means it builds on earlier research to gather more information about how well these treatments work and their potential side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

BeOne Medicines AG

Enrolment target

Start

27 Oct 2023

Head and Neck Squamous Cell Carcinoma

What is this study about?

This study is looking into new treatment options for a type of cancer called head and neck squamous cell carcinoma. This is a cancer that starts in the moist, flat cells that line parts of your head and neck, such as your mouth, nose, and throat. The study is specifically for people where this cancer has either returned after previous treatment or has spread to other parts of the body.

The main goal of the study is to test a medicine called Tislelizumab alongside other new, experimental drugs (BGB-A425 and LBL-007). Tislelizumab is an immunotherapy, which helps your body's own immune system fight cancer. Researchers want to find out how well these combinations of medicines work together to shrink tumours. They will also be closely watching for any side effects and how long the benefits of the treatment last.

By taking part in this study, patients could help doctors learn more about these new treatments, potentially leading to better options for people with this type of cancer in the future. It's an important step in understanding how these new drugs might improve care.

Key takeaways

Tests new drug combinations for recurrent or metastatic head and neck cancer.
Uses Tislelizumab (an immunotherapy) with other new medicines.
Aims to see how well treatments shrink tumours and their safety.
It's a Phase 2 study, building on earlier research.
Participation involves regular checks and monitoring.
You can stop participating at any time.

Who may be eligible?

To join this study, people need to be at least 18 years old. The study is open to both men and women.

There will be other, more detailed requirements that doctors will check to make sure the study is a good fit for you. These might include specific details about your cancer, your overall health, and any other medical conditions you have. They will also need to review any other treatments you've had in the past.

It's important that your doctor reviews all your medical information to see if you meet all the criteria for taking part in this research. They can explain these in more detail and help you understand if this study is suitable for you.

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 head and neck squamous cell carcinoma that has come back or spread?
Are you able to attend regular hospital visits and appointments?
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 join this study, you'll receive one of the study treatments regularly, likely through an infusion (drip). You'll have regular hospital visits for check-ups, scans (like CT scans or MRI scans) to see how the treatment is working, and blood tests to monitor your health and any side effects. You'll also be asked to report any new symptoms or side effects you experience. Your doctors will explain exactly how often these visits will be and what they will involve. The total duration of your participation could vary, as you would continue treatment as long as it is benefiting you and any side effects are manageable, with follow-up appointments continuing afterwards to monitor your health.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving a new, investigational treatment that might help your cancer when standard options haven't worked as well. However, there are also potential risks; all medicines can have side effects, and some of these new drugs might have unknown side effects. Your health will be closely monitored to manage any side effects. Remember, you can choose to withdraw from the study at any time for any reason, without it affecting your future 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
Italy
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Unverified
Spain

Common questions

What is head and neck squamous cell carcinoma?

It's a type of cancer that starts in the flat, scale-like cells that line wet surfaces in your head and neck, like your mouth, throat, or voice box.

What does 'recurrent or metastatic' mean?

'Recurrent' means the cancer has come back after treatment. 'Metastatic' means the cancer has spread from where it started to other parts of the body.

What is Tislelizumab?

Tislelizumab is a type of immunotherapy. It's a drug that helps your body's own immune system find and fight off cancer cells.

What does a 'Phase 2' study mean?

Phase 2 studies test new treatments in a larger group of people to see if they work well and are safe. They follow earlier studies that showed promise.

Will I know which treatment I'm getting?

This is an 'open-label' study, which means you and your study doctor will know which specific treatment you are receiving.