RecruitingPHASE3INTERVENTIONAL

A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)

This study, called LiGeR - HN1, is looking at a new way to treat head and neck cancer that has come back or spread. It compares two treatments: a combination of two drugs, petosemtamab and pembrolizumab, versus pembrolizumab given on its own. Researchers want to find out if the new combination treatment is more effective at fighting the cancer and if it is safe for patients. This is a Phase 3 study, meaning it's a later stage of research involving a larger number of people to confirm findings from earlier studies. It is for patients whose cancer shows a specific marker called PD-L1+ and who haven't had previous treatment for their advanced cancer.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Merus B.V.

Enrolment target

700

Start

25 Sep 2024

Estimated completion

01 Jul 2030

Head and Neck Squamous Cell Carcinoma

What is this study about?

This important study, known as LiGeR - HN1, is designed for people with a type of cancer called Head and Neck Squamous Cell Carcinoma. This is a common form of head and neck cancer. The study is particularly looking at cases where the cancer has either returned after previous treatment or has spread to other parts of the body, and cannot be cured by local treatments like surgery or radiotherapy alone. The main goal is to see if a new combination of two drugs, petosemtamab and pembrolizumab, works better and is safer than using pembrolizumab on its own as the first treatment for this advanced stage of cancer.

At the heart of the study are two medicines: petosemtamab and pembrolizumab. Pembrolizumab is a type of immunotherapy that helps your own immune system fight the cancer. Petosemtamab is another type of drug that targets specific cells. By combining them, doctors hope to give a more powerful punch against the cancer. Comparing the combination to pembrolizumab alone will help determine if adding petosemtamab makes a meaningful difference for patients.

Because this is a 'Phase 3' study, it means the treatments have already been tested in smaller groups of people and shown some promise. Now, a larger group of patients will take part to confirm these findings and gather more information about how well the treatment works and any side effects it might have. This stage is crucial before a new treatment can be considered for wider use, making your potential involvement very valuable to medical understanding.

Key takeaways

Tests a new combination treatment for advanced head and neck cancer.
Compares two drugs, petosemtamab plus pembrolizumab, against pembrolizumab alone.
Suitable for patients whose cancer has returned or spread and shows a specific marker (PD-L1+).
It's a Phase 3 study, aiming to confirm treatment effectiveness and safety.
Participation involves regular clinic visits for treatments and health checks.
You have the right to withdraw from the study at any time.

Who may be eligible?

To join this study, you would need to be at least 18 years old and have head and neck cancer that has been confirmed by a doctor, and has either come back or spread to other parts of your body, and can't be cured by local treatments. Your cancer must also have a specific marker called PD-L1. You shouldn't have received other treatments for your advanced cancer already, but certain past treatments for earlier stages might be okay if enough time has passed.

There are also specific health requirements to make sure you are well enough to participate. For example, your heart and other organs need to be working properly, and your general health should be good enough for you to manage the study treatments. The medical team will check blood tests and other factors to ensure your safety.

Some reasons why you might not be able to join include if your cancer has spread to your brain in a way that is causing symptoms or needs treatment, if you're taking medications that suppress your immune system, or if you've had major surgery or radiotherapy very recently. The study team will carefully review all your medical information to see if this study is a good fit for you.

Quick self-check

Are you 18 years old or older?
Do you have head and neck cancer that has come back or spread?
Has a doctor confirmed your cancer shows the PD-L1 marker?
Have you *not* had previous treatment for your advanced cancer (some exceptions apply)?
Is your general health, including heart and organ function, considered good?
Are you able to have a new biopsy or do you have a recent tissue sample available?

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

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive one of two treatments: either the combination of petosemtamab and pembrolizumab, or pembrolizumab on its own. This is done by chance, like flipping a coin, and neither you nor your doctor can choose which treatment you get. Throughout the study, you would have regular visits to the clinic for treatments, check-ups, and tests like blood work, scans (such as CT or MRI), and physical exams. These assessments help the doctors monitor your health, how the treatment is working, and if you are having any side effects.

Before starting, you would have a new biopsy (a small sample of tissue taken for examination) unless a recent sample is available. The treatment will continue for a period, and you will have follow-up appointments even after treatment ends, to keep track of your long-term health. The total duration of your active participation, including follow-up, will be determined by how you respond to the treatment and the study plan, but ongoing monitoring is standard in such trials.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing a new treatment that might be more effective than standard options for your condition, and you'll receive close medical monitoring. However, there are potential risks, as new treatments can have side effects that aren't fully known, or they might not work for everyone. These side effects can range from mild to serious. It's important to understand that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (205)

Site 164
Mobile, United States· Recruiting
Site 36
La Jolla, United States· Recruiting
Site 27
Los Angeles, United States· Recruiting
Site 16
Palo Alto, United States· Recruiting
Site 19
Newark, United States· Recruiting
Site 108
Washington D.C., United States· Recruiting
Site 14
Fort Myers, United States· Recruiting
Site 48
Orlando, United States· Withdrawn
Site 8
Orlando, United States· Recruiting
Site 21
St. Petersburg, United States· Recruiting
Site 20
West Palm Beach, United States· Recruiting
Site 171
Atlanta, United States· Recruiting

+193 more sites — see the official record for the full list.

Common questions

What type of cancer is this study for?

This study is for head and neck cancer that has either come back or spread to other parts of the body.

What are the treatments being tested?

One group will receive a combination of petosemtamab and pembrolizumab, and the other group will receive pembrolizumab alone.

Why is this study important?

It's a 'Phase 3' study, which means it helps determine if a new treatment combination is effective and safe enough to potentially become a new standard treatment.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, meaning you and your doctor will know which treatment you are receiving.

What happens if I want to stop participating?

You can leave the study at any time, for any reason, and it won't affect your future medical care.

How to find out more

Head of Clinical Operations

USenquiries@merus.nl +1 617 401 4499 Official trial record

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