Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase II Combination Study of NMS-01940153E and Atezolizumab with or without a prior priming with low dose decitabine for the Treatment of Adult Patients with Unresectable Hepatocellular Carcinoma (HCC) Previously Treated with Immune Checkpoint Inhibitors

This research study is for adults living with a type of liver cancer that can't be surgically removed (called hepatocellular carcinoma, or HCC). Participants will have previously received a type of treatment called an immune checkpoint inhibitor. The aim of the study is to test a new combination of medicines: NMS-01940153E and Atezolizumab (also known as Tecentriq), sometimes with a small starting dose of Decitabine (also known as Dacogen). Researchers are looking at how well this combination shrinks the cancer and helps people live longer. They will also carefully monitor any side effects to make sure the treatment is safe.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Nerviano Medical Sciences S.r.l.

Enrolment target

Start

19 Dec 2024

Unresectable Hepatocellular Carcinoma (HCC)

What is this study about?

This study is looking at a new way to treat a type of liver cancer that has spread and can't be removed by surgery. This kind of cancer is called unresectable hepatocellular carcinoma, or just HCC. The study is for people who have already tried a certain type of treatment called an "immune checkpoint inhibitor."

The main idea is to combine two existing drugs, Decitabine (which is also called Dacogen) and Atezolizumab (also known as Tecentriq), with a new experimental drug called NMS-01940153E. Researchers want to see if this new combination works better than current treatments. They'll be checking to see if the tumours shrink or disappear, how long people feel well, and how long people live overall.

This is a 'Phase II' study, which means it's one of the earlier steps in testing new treatments. It helps researchers understand if the treatment is effective and safe enough to be studied in a larger group of people. Your doctors and the study team will carefully monitor you throughout the study for any changes in your health.

Key takeaways

This study is for advanced liver cancer (HCC) that can't be removed by surgery.
It's for people who have already had a type of immunotherapy.
It tests a new combination of three medicines.
Researchers want to see if the new combination shrinks cancer and is safe.
Participation involves regular clinic visits for infusions, tests, and monitoring.

Who may be eligible?

This study is for adults aged 18 and over. It's for people who have been diagnosed with a type of liver cancer that doctors have said cannot be removed by surgery. You must have already received a type of treatment called an immune checkpoint inhibitor for your liver cancer.

There will be other medical checks and criteria that the study doctors will need to review to make sure this study is right and safe for you. These might include blood tests, how well your liver and kidneys are working, and your overall health condition.

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?
Have you been diagnosed with liver cancer (HCC) that cannot be surgically removed?
Have you already received a previous immunotherapy treatment for your liver cancer?
Are you generally well enough to participate in a clinical study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either the combination of NMS-01940153E and Atezolizumab, or the same combination with a starting dose of Decitabine. All these medicines are given as an infusion into your vein, usually in a hospital or clinic setting.

You will have regular visits to the clinic for treatments, blood tests, and scans to check how you are responding to the treatment and to monitor for any side effects. Your doctor and the study team will explain the exact schedule of visits and tests. They will also keep track of your general health and how you are feeling. The length of time you participate will depend on how your treatment is working and if you experience any side effects. There might also be follow-up appointments after you finish the treatment part of the study.

Potential risks and benefits

Taking part in a clinical trial means you might have access to a new treatment that isn't widely available yet. There is a chance the treatment could help shrink your cancer or slow its growth, but there is no guarantee it will work for everyone. Like all medicines, the study drugs can have side effects, which could be mild or more serious. The study team will explain these potential risks to you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

Common questions

What is an immune checkpoint inhibitor?

It's a type of cancer treatment that helps your body's immune system recognise and fight cancer cells more effectively.

What does 'unresectable' mean?

It means the cancer has spread in such a way that it cannot be completely removed by surgery.

Will I know which treatment group I'm in?

Your study doctor will be able to explain how the different treatment groups work in this study.

How long will I be on the treatment?

The length of treatment varies for each person and depends on how well you respond and any side effects you might have.

What are the common side effects of these types of drugs?

Side effects can vary, but commonly include fatigue, nausea, and changes in appetite. Your doctor will discuss specific potential side effects with you.