Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, randomized, open-label three-arm clinical study to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3475) versus standard of care chemotherapy and lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and immunotherapy (PD-1/PD-L1 inhibitors) (LEAP-009)

This study is for people in the UK with head and neck cancer that has returned or spread, and who have already had standard treatments including platinum-based chemotherapy and immunotherapy. We are comparing different treatment options: a new drug called Lenvatinib on its own, Lenvatinib combined with another drug called Pembrolizumab, and standard chemotherapy treatments. The main goal is to find out if these new combinations can help people live longer. We also want to see if the treatments shrink the cancer, how long any improvements last, and what side effects people might experience. This is a "Phase 2" study, meaning we are exploring these treatments in more detail to understand their safety and how well they work.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

158

Start

29 Apr 2024

Recurrent or metastatic squamous cell carcinoma of the head and neck

What is this study about?

This clinical trial is designed for people who have been diagnosed with a type of cancer called squamous cell carcinoma of the head and neck. This is cancer that starts in the flat cells lining moist surfaces, like the inside of your mouth or throat. The study is for people whose cancer has come back (recurred) or spread to other parts of the body (metastatic), and who have already received certain treatments that are no longer working. Specifically, this includes platinum-based chemotherapy and immunotherapy, which are common treatments for this type of cancer.

The main aim of this study is to compare how well different treatments work. Participants will be split into three groups. One group will receive a new drug called Lenvatinib on its own. Another group will receive a combination of Lenvatinib and Pembrolizumab (also known as Keytruda). The third group will receive standard chemotherapy treatments, which could include drugs like Docetaxel or Paclitaxel, or a combination with Cetuximab or Capecitabine depending on what is best for them. The study is open-label, which means both the participants and the doctors will know which treatment is being given.

We want to see if the new treatments, Lenvatinib alone or in combination with Pembrolizumab, can help people live longer compared to standard chemotherapy. We will also carefully watch to see if the treatments shrink the cancer (this is called the "objective response rate"), how long any response lasts, and how long people live without their cancer growing or spreading (this is called "progression-free survival"). Understanding any side effects is also a very important part of this study.

Key takeaways

This study explores new treatments for recurrent/metastatic head and neck cancer.
It's for people whose cancer has progressed after platinum chemotherapy and immunotherapy.
Treatments include Lenvatinib alone, Lenvatinib with Pembrolizumab, or standard chemotherapy.
The main aim is to see if these new treatments help people live longer.
Researchers will also look at how well the treatments shrink the cancer and what side effects occur.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. The study is open to both men and women. Importantly, you must have squamous cell carcinoma of the head and neck that has come back or spread to other parts of your body.

Another key requirement is that your cancer must have previously been treated with specific types of therapy, and these treatments are no longer working for you. This includes chemotherapy medicines that contain platinum (like cisplatin) and also a type of treatment called immunotherapy (medicines like PD-1 or PD-L1 inhibitors, for example, Pembrolizumab).

The research team will have a more detailed list of criteria to check if this study is right for you. They will review your medical history and test results to ensure your safety and that the study is suitable for your specific situation.

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?
Do you have squamous cell carcinoma of the head and neck that has come back or spread?
Has your cancer progressed after previous platinum-based chemotherapy?
Has your cancer progressed after previous immunotherapy (like PD-1/PD-L1 inhibitors)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of three treatment groups. You will receive either Lenvatinib alone, Lenvatinib combined with Pembrolizumab, or a standard chemotherapy treatment. The specific schedule for your treatments will be explained, but it will involve regular visits to the hospital or clinic for infusions or to pick up oral medication. During these visits, the study team will monitor your health closely. This will include blood tests, physical examinations, and scans to see how the treatment is affecting your cancer. These assessments help the doctors understand how well the treatment is working and watch for any side effects. The total duration of your participation in the study will depend on how you respond to the treatment and should be discussed with the study team.

Potential risks and benefits

Taking part in this study could offer a potential benefit if the new treatments prove to be more effective than current standard options for your type of cancer. However, like all medical treatments, there are potential risks, and you may experience side effects from the study drugs. The research team will explain all known and potential side effects in detail. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (6)

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

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Unverified
Norway
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Unverified
Denmark
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Unverified
Portugal
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Unverified
Romania
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Unverified
Spain
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Unverified
France

Common questions

What kind of head and neck cancer is this study for?

This study is for squamous cell carcinoma of the head and neck, which has either come back or spread to other parts of the body.

What does 'Phase 2' mean?

Phase 2 means the study is exploring new treatments in more detail to understand their safety and how well they work for a specific condition.

Will I know which treatment I am getting?

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

What are the main things the doctors want to find out?

The main goal is to see if the new treatments help people live longer. They also want to see if the cancer shrinks, how long any improvements last, and what side effects people have.

What if I get side effects from the treatment?

The study team will closely monitor you for any side effects and provide care and support to manage them. You can also withdraw from the study at any time.