Study on the Effectiveness of NMS-01940153E, Atezolizumab, and Decitabine in Adults with Unresectable Liver Cancer Previously Treated with Other Cancer Medicines

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What is this study about?

This clinical trial is focused on studying a type of liver cancer called Unresectable Hepatocellular Carcinoma (HCC), which means the cancer cannot be removed by surgery. The study is exploring the effectiveness of a new treatment combination for patients who have already been treated with other cancer medicines known as immune checkpoint inhibitors. The treatment involves a combination of three medications: NMS-01940153E, Atezolizumab, and a low dose of Decitabine. Atezolizumab is an immune checkpoint inhibitor, which helps the immune system recognize and attack cancer cells. Decitabine is a medication that can help make cancer cells more sensitive to treatment. NMS-01940153E is an investigational drug, meaning it is still being studied and is not yet approved for general use.

The purpose of this study is to determine how well these medications work together in treating patients with HCC. The study will have different parts: some patients will receive all three medications, while others will receive only NMS-01940153E and Atezolizumab. The study will monitor the patients’ response to the treatment over time, looking at how the cancer responds and how long the response lasts. The study will also assess the safety of the treatment by observing any side effects that may occur.

Participants in the study will receive the medications through an intravenous infusion, which means the drugs are given directly into a vein. The study will take place over several months, with regular check-ups to monitor the patients’ health and the progress of the treatment. The goal is to find out if this combination of medications can provide a new treatment option for patients with HCC who have limited options after previous treatments.

1 initial treatment phase

The treatment begins with the administration of decitabine as a priming agent. This involves an intravenous infusion of Dacogen 50 mg powder for concentrate for solution for infusion. The specific dosage and frequency will be determined by the medical team based on individual patient needs.

2 combination therapy phase

Following the priming phase, the patient will receive a combination of NMS-01940153E and atezolizumab. Both medications are administered through intravenous infusion. NMS-01940153E is a new investigational drug, and atezolizumab is provided as Tecentriq 840 mg concentrate for solution for infusion.

The frequency and duration of these infusions will be specified by the healthcare provider, tailored to the patient’s response and overall health condition.

3 monitoring and assessment phase

Throughout the trial, regular monitoring will occur to assess the treatment’s effectiveness and safety. This includes imaging tests such as computed tomography (CT), positron emission tomography (PET), or magnetic resonance imaging (MRI) to measure tumor response according to RECIST 1.1 criteria.

The patient’s overall health, including any side effects or adverse events, will be closely monitored. Adjustments to the treatment plan may be made based on these assessments.

4 follow-up phase

After completing the treatment cycles, a follow-up period will be conducted to evaluate the long-term effects of the therapy. This includes monitoring for any delayed side effects and assessing the duration of response and overall survival.

The follow-up schedule will be determined by the healthcare team, ensuring comprehensive post-treatment care.

Who Can Join the Study?

You must have a diagnosis of Hepatocellular Carcinoma (HCC), which is a type of liver cancer, confirmed by tests like a biopsy or imaging scans.
You must be at least 18 years old.
Your disease should not be treatable with methods that aim to cure, such as a liver transplant, surgery, or radiofrequency ablation. It should also not be suitable for or resistant to treatments that target specific areas of the liver.
You need to have at least one measurable tumor that can be seen on scans like a CT, PET, or MRI. This tumor should either not have been treated before or, if treated, it must have grown again before joining the study.
You should have received only one previous treatment that included atezolizumab plus bevacizumab or another approved immune checkpoint inhibitor as the first treatment option.
If you were treated with a previous immune checkpoint inhibitor, you must have completed at least four treatment cycles and had at least two tumor assessments. At least one of these assessments should have shown that the disease was stable, partially responded, or completely responded to the treatment.
You must have proof that the disease has progressed on the previous immune checkpoint inhibitor treatment before joining the study.
Your liver cancer should be at stage B or C according to the Barcelona Clinic Liver Cancer staging system, which means it is not suitable for treatments targeting specific areas of the liver.
You should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means you are fully active or have some symptoms but can still carry out light work.
You need a Child-Pugh score of A, which is a measure of liver function, within 7 days before joining the study.

Who Cannot Join the Study?

Patients who have not been previously treated with immune checkpoint inhibitors. These are medicines that help the body’s immune system fight cancer.
Patients with resectable hepatocellular carcinoma (HCC). This means the cancer can be removed by surgery.
Patients who are part of a vulnerable population. This refers to groups of people who might need special protection or care, such as children or those unable to make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
IRCCS Humanitas Research Hospital	Rozzano	Italy
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	09.12.2024
Spain	Not recruiting	09.12.2024

Trial locations

Investigated drugs:

NMS-01940153E is an experimental medication being studied for its potential to treat liver cancer that cannot be removed by surgery. It is being tested to see how well it works when used in combination with other treatments.

Atezolizumab is a type of medication known as an immune checkpoint inhibitor. It helps the body’s immune system recognize and attack cancer cells more effectively. In this study, it is used alongside other treatments to see if it can improve outcomes for patients with liver cancer.

Decitabine is a medication that is sometimes used to help prepare the body to respond better to other cancer treatments. In this study, it is used in low doses to see if it can enhance the effectiveness of the other medications being tested.

Unresectable Hepatocellular Carcinoma – This is a type of liver cancer that cannot be removed through surgery. It originates in the liver cells and is the most common form of primary liver cancer. The disease progresses as the cancer cells grow and spread within the liver and potentially to other parts of the body. As it advances, it may cause symptoms such as abdominal pain, weight loss, and jaundice. The progression can vary, with some tumors growing slowly while others may spread more rapidly. The condition is often diagnosed at an advanced stage due to the lack of early symptoms.

Trial ID:

2024-516737-12-00

Protocol code:

MPSA-153-002

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of NMS-01940153E, Atezolizumab, and Decitabine in Adults with Unresectable Liver Cancer Previously Treated with Other Cancer Medicines

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?