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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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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 trial?

10 criteria

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 trial?

3 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Fondazione I.R.C.C.S. Istituto Neurologico Besta
Milan, Italy
Verified
Fundacion Instituto Valenciano De Oncologia
Valencia, Spain
Responsive
Istituto Oncologico Veneto
Padua, Italy

Trial locations

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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.

What is already known about the treatment

NMS-01940153E
This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating unresectable hepatocellular carcinoma (HCC). It is being tested in combination with atezolizumab, with or without prior priming with low-dose decitabine. The main therapeutic indication is for patients with HCC who have previously been treated with immune checkpoint inhibitors. NMS-01940153E works by targeting specific molecular pathways involved in cancer cell growth and survival, aiming to enhance the immune system's ability to fight cancer. It is classified as an investigational drug in the field of oncology.
Atezolizumab
This medication is given through an intravenous infusion and is an established treatment in the field of oncology, particularly for various types of cancer, including unresectable hepatocellular carcinoma (HCC). In the current study, it is being used in combination with NMS-01940153E, with or without low-dose decitabine priming. Atezolizumab is an immune checkpoint inhibitor that works by blocking the PD-L1 protein, helping the immune system to detect and attack cancer cells more effectively. It is classified as a monoclonal antibody used in cancer immunotherapy.

Investigated diseases

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.