Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

An Open-Label, Multicenter Phase 2 Basket Study to Evaluate the Antitumor Activity and Safety of Lenvatinib in Children, Adolescents, and Young Adults with Relapsed or Refractory Solid Malignancies

This research study is testing a medicine called lenvatinib in children, teenagers, and young adults (aged 2 to 21 years old) who have specific types of cancer. These cancers include certain brain tumours (High Grade Glioma), muscle tumours (Rhabdomyosarcoma), bone/soft tissue tumours (Ewing Sarcoma/pPNET), or other solid tumours, and importantly, their cancer has either returned or hasn't improved with other treatments. The main goal is to find out if lenvatinib can reduce the size of these tumours and whether it is safe for young patients. Researchers will also look at how long people stay well without their cancer getting worse, how long any improvements last, and if patients find the liquid form of the medicine easy to take.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

18 Jun 2024

Between ages 2 and 21 and have High Grade Glioma (HGG)Rhabdomyosarcoma (RMS)Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (pPNET)or other solid tumor types (except osteosarcoma)

What is this study about?

This research study is about a medicine called lenvatinib. It's being tested to see if it can help children, teenagers, and young adults who have certain types of cancer. The study is for those whose cancer has either come back or hasn't responded to other treatments. The main purpose is to observe how well lenvatinib works against different kinds of solid tumours and to make sure it's safe for patients in this age group.

The types of cancers included in this study are specific brain tumours (called High Grade Glioma), muscle tumours (called Rhabdomyosarcoma), and particular bone or soft tissue tumours (Ewing Sarcoma/pPNET). It also includes some other solid tumour types, but not a specific type of bone tumour called osteosarcoma. Researchers will be paying close attention to whether the tumours shrink after taking lenvatinib. This will be checked at 16 weeks into the study, and they will also monitor how long people respond to the medicine and how long they stay well without their cancer growing.

Beyond checking how well the medicine works, a very important part of the study is to understand its safety. The team will carefully record any side effects that people experience. They will also look at how much of the medicine gets into the body and how patients feel about taking the liquid version of lenvatinib. This information is crucial for understanding if lenvatinib could be a helpful treatment option for young people with these challenging cancers in the future.

Key takeaways

This study is for children and young adults (2-21 years old) with specific cancers.
It's testing a medicine called lenvatinib when cancer has returned or other treatments haven't worked.
The study aims to see if lenvatinib can shrink tumours and how safe it is.
Participation involves taking the medicine and having regular check-ups and scans.
You can stop participating at any time.
This is a Phase 2 study, meaning it's still in early stages of testing this medicine for these conditions.

Who may be eligible?

To join this study, people need to be between 2 and 21 years old. They must have been diagnosed with certain types of cancer where previous treatments haven't worked or the cancer has returned. The specific types of cancer include a type of brain tumour called High Grade Glioma, a muscle tumour called Rhabdomyosarcoma, or a bone/soft tissue tumour called Ewing Sarcoma/pPNET. Other types of solid tumours are also included, but not a bone cancer called osteosarcoma.

All participants will receive the study medicine, lenvatinib.

This study is open to both boys and girls. Before joining, a medical team will carefully check to make sure it's the right choice for each person.

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 between 2 and 21 years old?
Do you have a High Grade Glioma, Rhabdomyosarcoma, or Ewing Sarcoma/pPNET?
Has your cancer come back or not responded to previous treatments?
Do you *not* have a type of bone cancer called osteosarcoma?
Are you able to attend regular hospital/clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be taking the medicine called lenvatinib. This medicine is likely given regularly, and the study team will provide full instructions on how and when to take it. You would have regular visits to the hospital or clinic to check how you are doing, measure any changes in your cancer, and see if you are experiencing any side effects.

These visits will involve assessments like scans to measure your tumours. The main check to see how the medicine is working will happen around 16 weeks after you start treatment. The study team will continue to monitor you for as long as you are on the medicine and may follow up afterwards to understand the long-term effects. The total duration of your participation will depend on how you respond to the treatment and the study plan, but there will be ongoing checks and monitoring throughout.

Potential risks and benefits

Taking part in this study might offer a potential benefit if lenvatinib helps to shrink your tumour or slow its growth, especially if other treatments haven't worked or your cancer has returned. However, like all medicines, lenvatinib may cause side effects, which could range from mild to serious. The study team will carefully monitor you for these. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (4)

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

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Unverified
Spain
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Unverified
Italy
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Unverified
France
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Unverified
Czechia

Common questions

What is lenvatinib?

Lenvatinib is a medicine being tested in this study to see if it can help treat certain types of cancer in young people.

Who can take part in this study?

Children, teenagers, and young adults aged 2 to 21 with specific types of cancer, where their cancer hasn't responded to previous treatments or has returned.

What kinds of cancer are included?

The study includes certain brain tumours (High Grade Glioma), muscle tumours (Rhabdomyosarcoma), bone/soft tissue tumours (Ewing Sarcoma/pPNET), and other solid tumours (but not osteosarcoma).

How long will I take the medicine?

The length of time you take the medicine will depend on how your body responds to the treatment and what your study doctor decides is best for you.

What is the main goal of the study?

The main goal is to find out if lenvatinib can make tumours smaller and if it is safe for young patients to take.