Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

SOLARIS – A phase-II open-label study of pembrolizumab and lenvatinib in patients with advanced stage hepatocellular carcinoma who are refractory to atezolizumab and bevacizumab/ IO-based therapy

This study, called SOLARIS, is looking at new treatment options for people in the UK with advanced liver cancer (hepatocellular carcinoma) that has continued to grow despite earlier treatments like atezolizumab and bevacizumab, or other similar immune-based therapies. Researchers want to see if combining two existing medications, LENVIMA (lenvatinib) and KEYTRUDA (pembrolizumab), can help shrink the cancer. This is a 'Phase II' clinical trial, meaning it's focusing on how well the treatment works and its safety, rather than comparing it directly to existing treatments. The main thing they'll be looking at is the percentage of people whose cancer shrinks or completely disappears after taking the combined medicines.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Enrolment target

Start

25 Oct 2024

advanced stage hepatocellular carcinoma

What is this study about?

When someone has advanced liver cancer, it means the cancer has spread or is difficult to treat with standard methods. Unfortunately, for some people, the initial treatments they receive might not work as well as hoped, or the cancer might start to grow again. In these situations, doctors and researchers are always looking for new and more effective ways to help.

This study is exploring a new approach for people whose advanced liver cancer hasn't responded to previous immune-based treatments. It combines two medicines that are already approved for use in certain cancers, but not necessarily in this specific situation or combination. LENVIMA is a medication that works by blocking signals that cancer cells need to grow and form new blood vessels. KEYTRUDA is an immunotherapy drug that helps your body's own immune system fight the cancer.

The main goal of this study is to see how many people experience their cancer shrinking or disappearing after taking both LENVIMA and KEYTRUDA together. They will also keep a close eye on how long people live without their cancer getting worse, how long they live overall, and any side effects or problems that might occur. This information will help doctors understand if this combination could be a useful new treatment option for people with advanced liver cancer.

Key takeaways

This study is for people with advanced liver cancer that hasn't responded to previous treatments.
It tests a combination of two existing drugs, LENVIMA and KEYTRUDA, given together.
The main aim is to see how many people's cancer shrinks or disappears with this new combination.
It's a Phase II study, focusing on the treatment's effectiveness and safety.
You would receive both oral capsules and intravenous drips as part of the treatment.
Regular check-ups and monitoring are a key part of taking part.

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.

The most important thing is that the participant has advanced liver cancer that has not responded to previous treatments. This means they would have already tried certain therapies, like atezolizumab and bevacizumab, or other treatments that boost the immune system to fight cancer, and unfortunately, their cancer has continued to grow or hasn't improved.

The medical team will carefully check other specific health conditions and previous treatments to make sure it's safe for someone to take part in this particular study. They will also look at overall health and how well certain organs are working.

Quick self-check

Are you 18 years old or older?
Do you have advanced liver cancer?
Has your liver cancer continued to grow despite previous treatments (like atezolizumab and bevacizumab or similar immune therapies)?
Are you generally well enough to take part in a clinical trial?
Are you willing and able to take capsules by mouth and receive intravenous infusions?

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 receive two different medications: LENVIMA hard capsules that you take by mouth, and KEYTRUDA, which is given through a drip into your vein. The research team will regularly check how you are doing, including blood tests, scans, and physical examinations. These visits will help them understand how the treatment is working and whether you are experiencing any side effects.

The study will follow your health closely over time. This includes checking how your cancer responds to the treatment, how long you stay well, and your overall health. You will have regular appointments and tests throughout the treatment period and potentially for some time after the treatment ends to monitor your progress and long-term health. The total duration of your participation will depend on how you respond to the treatment and the study’s follow-up plan, which the study team will explain in detail.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and potential risks. A potential benefit of this study is that the combination of LENVIMA and KEYTRUDA might shrink your cancer or slow its growth, which could improve your health and quality of life. However, there's no guarantee the treatment will work for everyone, and it might not work for you. Like all medications, LENVIMA and KEYTRUDA can cause side effects, which range from mild to serious. The study team will discuss all known possible risks with you in detail. You have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (1)

—
Germany

Common questions

What is 'advanced stage hepatocellular carcinoma'?

This is the medical name for advanced liver cancer, meaning the cancer has grown or spread and needs ongoing treatment.

What does it mean if my cancer is 'refractory' to previous treatments?

It means your liver cancer has not responded well to treatments you've had before, and it has either continued to grow or didn't get better.

Are LENVIMA and KEYTRUDA new medicines?

Both LENVIMA and KEYTRUDA are existing medicines. This study is looking at using them together for advanced liver cancer, especially when previous treatments haven't worked.

What is 'Phase II' of a clinical trial?

In a Phase II trial, researchers are mainly looking at how well a new treatment works and its safety in a group of people with the specific condition.

What is an 'Objective Response Rate (ORR)'?

This is how doctors measure if a cancer treatment has worked. It means they look at the percentage of patients whose cancer shrinks significantly or completely disappears.