Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase II, Open-Label Study of preliminary efficacy of Sitravatinib in Combination with Tislelizumab in Patients with Metastatic Uveal Melanoma with liver metastases.

This study is testing two medicines, Sitravatinib and Tislelizumab, given together to see if they can effectively treat uveal melanoma. This is a rare type of cancer that starts in the eye and, in this study, has spread to the liver. Researchers want to find out how many patients see their tumours shrink after taking these new drugs. They will also look at how long people live without their cancer getting worse, and how long they live overall. The study is open to adults aged 18 and over, of any sex. It's hoped that this combination treatment could offer a new option for patients with this condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Grupo Espanol Multidisciplinar De Melanoma

Enrolment target

Start

10 Dec 2024

Uveal melanoma

What is this study about?

This study is about a type of cancer called uveal melanoma. This is a rare cancer that starts in a part of the eye called the uvea. Sometimes, this cancer can spread to other parts of the body, most commonly the liver. When it spreads, it's called metastatic uveal melanoma, and it can be difficult to treat.

Researchers are testing two new medicines, Sitravatinib and Tislelizumab, given together. These medicines work in different ways to fight cancer. Sitravatinib aims to block signals that cancer cells use to grow, while Tislelizumab is an immunotherapy that helps your own immune system recognise and attack cancer cells. The main goal of this study is to see how many people's cancers shrink or disappear after taking these drugs.

By taking part, you would be helping doctors understand if this combination treatment is effective for uveal melanoma that has spread to the liver. If it works well, it could become a new treatment option for other patients in the future. We also want to find out how long people taking these medicines live without their cancer getting worse, and how long they live overall. This information is really important for developing better ways to treat this condition.

Key takeaways

This study is testing two new medicines for uveal melanoma that has spread to the liver.
It aims to see if the medicines can shrink or stop the cancer from growing.
It's a 'Phase II' study, which means it's an early look at how well the treatment works.
Participants will receive the new treatment and have regular health checks.
The study is for adults aged 18 and over, of any gender.

Who may be eligible?

To join this study, you would need to be 18 years or older. This study is open to both men and women.

You would need to have been diagnosed with uveal melanoma that has spread to your liver. Your doctors would confirm these details before you could take part.

There might be other health requirements or previous treatments that could affect whether you can join. These will be discussed in detail with your study doctor.

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 uveal melanoma?
Has your uveal melanoma spread to your liver?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medicines, Sitravatinib and Tislelizumab, as part of your treatment. You'll have regular hospital visits for appointments and tests, which might include blood tests, scans, and other checks to see how you're responding to the treatment and to monitor your health. Your doctors and the study team will explain the schedule of these visits and what each involves. You will be closely monitored throughout the study, and your health will be checked regularly. The total duration of your participation will depend on how you respond to the treatment and will be discussed with you by the study team.

Potential risks and benefits

Taking part in this study may offer some potential benefits, as the treatments you receive could help shrink your cancer or slow its growth. However, there's no guarantee the treatment will work for everyone, and it's also possible you could experience side effects from the medicines, which will be carefully explained to you by the study team. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What is uveal melanoma?

Uveal melanoma is a rare type of cancer that starts in a part of the eye called the uvea.

What does 'metastatic' mean?

Metastatic means the cancer has spread from where it started (in this case, your eye) to other parts of the body, like your liver.

What are Sitravatinib and Tislelizumab?

These are two experimental medicines that work in different ways to fight cancer. Sitravatinib blocks cancer growth signals, and Tislelizumab helps your immune system attack cancer cells.

What does 'Phase II' mean?

Phase II means this is an early study to see if the treatment works and is safe. It's not yet approved as a standard treatment.

What is the main goal of the study?

The main goal is to see how many people's cancers shrink or disappear after taking these combined medicines.