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Study on Heart Function Changes in Cancer Patients Treated with Nivolumab or Pembrolizumab

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 focuses on studying the effects of certain cancer treatments on heart function. The diseases being studied are various types of cancer. The treatments involved in this study are two medications: nivolumab and pembrolizumab. These medications are part of a group of drugs known as immunotherapies, which help the body's immune system fight cancer. Nivolumab is also known by the code names BMS936558 and ABP 206, while pembrolizumab is known by several code names, including Lambrolizumab and MK-3475.

The purpose of the study is to observe how the heart's left ventricle, a chamber responsible for pumping blood, functions over time in patients receiving these treatments. This is done by monitoring patients in a specialized unit that focuses on the heart health of cancer patients, known as a Cardio-Oncology unit. The study will track changes in heart function using a specific measurement called the global longitudinal strain value, which helps assess how well the heart muscle is working.

Participants in the study will receive either nivolumab or pembrolizumab through an intravenous infusion, which means the medication is given directly into a vein. The study will last for a period of up to six months, during which the heart function of the participants will be regularly monitored. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments. The study aims to provide valuable information on how these cancer treatments might affect heart health, helping to improve care for future patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as being selected to receive treatment with nivolumab or pembrolizumab and affiliation with a national insurance scheme.
Step 2
Treatment administration
Receive treatment with either nivolumab or pembrolizumab. Both medications are administered through an intravenous infusion.
The specific dosage, frequency, and duration of administration are determined by the healthcare provider based on individual needs and treatment protocols.
Step 3
Monitoring cardiac function
The main objective is to monitor the evolution of the heart's left ventricular function during the treatment.
This is measured by the global longitudinal strain value, which helps assess heart function over time.
Step 4
Follow-up
Regular follow-up appointments are scheduled to track the progress of the treatment and the heart's response.
These appointments are conducted in a Cardio-Oncology unit, where specialized care is provided.
Step 5
Completion of the study
The study is estimated to conclude by October 8, 2026.
Upon completion, a final assessment of the heart's function is conducted to evaluate the overall impact of the treatment.

Who can join the trial?

6 criteria

Patients must have **cancer**.
Patients must be selected to receive treatment with **nivolumab** or **pembrolizumab**. These are medications used to treat certain types of cancer.
Patients must be affiliated with a national insurance scheme, meaning they should have health insurance provided by the government or a similar organization.
Both **male** and **female** patients can participate.
Patients of all ages, except for very young children, are eligible.
Patients should not be part of a vulnerable population, which means they should not be in a group that needs special protection or care.

Who cannot join the trial?

3 criteria

Patients who do not have a diagnosis of cancer cannot participate.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection, like children or people with certain disabilities.

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Assistance Publique Hopitaux De Marseille
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Marseille, France

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Investigated drugs

Nivolumab
is a type of cancer treatment known as immunotherapy. It works by helping your immune system recognize and attack cancer cells. This medication is used to treat various types of cancer by blocking a protein called PD-1, which can prevent the immune system from attacking cancer cells.
Pembrolizumab
is another immunotherapy medication that helps your immune system fight cancer. Like nivolumab, it targets the PD-1 protein, allowing your immune system to better detect and destroy cancer cells. This treatment is used for different kinds of cancer and is part of the study to observe its effects on heart function.

What is already known about the treatment

Nivolumab
Nivolumab is administered intravenously, typically through an infusion into a vein. It is currently used in medicine as an immunotherapy for various types of cancer, with ongoing research to understand its effects on cardiac function. The main therapeutic indication for nivolumab is cancer treatment, particularly in cases where it can help the immune system target and destroy cancer cells. At the molecular level, nivolumab works by blocking the PD-1 protein on immune cells, preventing cancer cells from evading the immune response. It is classified as a monoclonal antibody in pharmacology.
Pembrolizumab
Pembrolizumab is given through an intravenous infusion, allowing the medication to enter the bloodstream directly. It is widely recognized in medical literature as a treatment for several cancers, with studies examining its impact on heart function during therapy. The primary use of pembrolizumab is to treat cancer by enhancing the body's immune response against tumor cells. It functions by inhibiting the PD-1 pathway, which helps the immune system recognize and attack cancer cells more effectively. Pembrolizumab is also classified as a monoclonal antibody.

Investigated diseases

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells. If the spread is not controlled, it can interfere with essential bodily functions. Cancer can develop in almost any organ or tissue, such as the lung, colon, breast, skin, bones, or nerve tissue. The progression of cancer varies depending on the type and location, but it generally involves the growth of a primary tumor, which may invade nearby tissues and spread to distant parts of the body through the bloodstream or lymphatic system. The rate of progression can be slow or rapid, and symptoms may not appear until the disease is advanced.