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Study of Heart and Blood Vessel Side Effects in Cancer Patients Receiving Immune Checkpoint Inhibitor Drug Combination Treatment

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What is this trial about?

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

This study is looking at people with different types of cancer who will receive certain cancer treatments. The cancers being studied include non small cell lung cancer, renal cell carcinoma (a type of kidney cancer), small cell lung cancer, tumors of the head and neck region, bladder carcinoma, and malignant melanoma (a serious form of skin cancer). The treatments being used are called immune checkpoint inhibitors, which are medicines that help the body's immune system fight cancer. The specific medicines that may be used in this study are durvalumab (also known by the code name MEDI4736), ipilimumab, nivolumab (also known by the code name BMS936558), atezolizumab, and pembrolizumab (also known by the code name MK-3475). All of these medicines are given through an infusion, which means they are delivered slowly into a vein.

The purpose of this study is to investigate the cardiovascular side effects of immune checkpoint inhibitors, which means looking at how these cancer treatments might affect the heart and blood vessels. The study will monitor patients who are receiving these treatments as part of their regular cancer care. During the study, doctors will check for various heart-related problems that might develop or get worse during treatment. The treatment period with these medicines can last up to twelve months.

The main focus of the study is to track serious heart-related events, including death from heart problems, heart attacks, strokes, chest pain that requires hospital care or urgent treatment to restore blood flow to the heart, and hospital stays due to heart failure (when the heart cannot pump blood well enough). The study will also look at other heart and blood vessel problems such as new or worsening high blood pressure, irregular heartbeats, blood clots in the veins, and other heart-related issues that require hospital admission. This research aims to better understand how these cancer treatments affect the heart and blood vessels so that doctors can better monitor and care for patients receiving these medicines.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and treatment start
Your treatment with immune checkpoint inhibitor therapy will begin. These are medications that help your immune system fight cancer cells.
You will receive one of the following medications through infusion, which means the medication will be delivered directly into your vein: durvalumab, ipilimumab, nivolumab, atezolizumab, or pembrolizumab.
The specific medication, dosage, and frequency of administration will be determined by your treatment plan for your cancer type, which may include non small cell lung cancer, renal cell carcinoma (kidney cancer), small cell lung cancer, tumors of the head and neck region, bladder carcinoma, or malignant melanoma (skin cancer).
Step 2
Cardiovascular monitoring during treatment
Throughout your cancer treatment, your heart and blood vessel health will be monitored to identify any potential side effects from the immune checkpoint inhibitor therapy.
This monitoring will assess for several cardiovascular conditions, including: cardiovascular death, heart attack (myocardial infarction), stroke, unstable angina (chest pain requiring hospitalization or urgent treatment), and hospitalization due to heart failure.
Additional assessments will check for: newly developing or worsening high blood pressure (arterial hypertension), irregular heart rhythms (cardiac arrhythmias), blood clots in veins (venous thromboembolic events), and other heart-related side effects.
Your medical history will be reviewed as part of the ongoing assessment.
Step 3
Ongoing treatment and follow-up
Your immune checkpoint inhibitor treatment will continue according to your prescribed schedule.
The cardiovascular monitoring will continue throughout the duration of your treatment to ensure any heart or blood vessel side effects are identified.
The study is expected to continue until January 2031, but your individual participation will depend on your treatment duration.

Who can join the trial?

4 criteria

You must be a patient who is planning to receive immune checkpoint inhibitor therapy, which is a type of cancer treatment that helps your immune system fight cancer cells
You must be at least 18 years old
You must be willing to sign the patient information sheet and consent form, which are documents that explain the study and confirm you agree to participate
Your medical history must be available, meaning your doctors need to have access to your past and current health records

Who cannot join the trial?

12 criteria

You cannot participate if you have heart failure, which means your heart is not able to pump blood effectively to meet your body's needs
You cannot participate if you have severe heart rhythm problems, which are irregular heartbeats that can be dangerous
You cannot participate if you have had a heart attack in the last 6 months, which occurs when blood flow to part of the heart muscle is blocked
You cannot participate if you have unstable angina, which is chest pain that occurs unpredictably and may signal a heart attack
You cannot participate if you have uncontrolled high blood pressure, meaning your blood pressure readings remain too high even with treatment
You cannot participate if you are pregnant or breastfeeding
You cannot participate if you have any other active cancer besides the ones being studied
You cannot participate if you have an autoimmune disease, which is a condition where your immune system mistakenly attacks your own body
You cannot participate if you are taking immunosuppressive medications, which are drugs that weaken your immune system
You cannot participate if you have had an organ transplant in the past
You cannot participate if you have a known allergy to immune checkpoint inhibitors or their components
You cannot participate if you have severe kidney or liver problems that prevent your organs from working properly

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Semmelweis University
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Budapest, Hungary

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Investigated drugs

Immune checkpoint inhibitors are a type of cancer treatment that helps your body's immune system fight cancer cells. These medications work by blocking certain proteins that prevent your immune system from attacking cancer. In this study, researchers are looking at how these cancer treatments may affect your heart and blood vessels.

What is already known about the treatment

Immune Checkpoint Inhibitors – Immune checkpoint inhibitors are medications given through an intravenous infusion (directly into a vein) that work by blocking certain proteins on immune cells or cancer cells, allowing the body's immune system to recognize and attack cancer cells more effectively. These drugs are currently approved and widely used in modern cancer treatment for various types of cancer including non-small cell lung cancer, small cell lung cancer, kidney cancer, bladder cancer, melanoma, and cancers of the head and neck region. At the molecular level, they block checkpoint proteins such as PD-1, PD-L1, or CTLA-4, which normally act as brakes on the immune system, thereby unleashing the immune response against tumor cells. These medications belong to the pharmacological class of immunotherapy agents or biological response modifiers, representing a major advancement in cancer treatment by harnessing the patient's own immune system to fight cancer.

Investigated diseases

Non-Small Cell Lung Cancer
This is the most common type of lung cancer, accounting for about 85% of all lung cases. The disease begins when cells in the lungs start growing abnormally and uncontrollably, forming tumors that can interfere with breathing. As the cancer progresses, it can spread to nearby lymph nodes and other parts of the body. Symptoms may include persistent cough, chest pain, shortness of breath, and coughing up blood. The disease typically develops slowly compared to other types of lung cancer. Growth rate and spread pattern vary depending on the specific subtype of non-small cell lung cancer.
Renal Cell Carcinoma
This is a type of kidney cancer that originates in the lining of the small tubes within the kidney that filter blood and produce urine. The cancer usually begins as a single tumor in one kidney, but it can affect both kidneys in rare cases. As the disease advances, the tumor grows larger and may invade nearby tissues and blood vessels. Cancer cells can break away and spread through the bloodstream or lymphatic system to other organs. Early stages often produce no symptoms, but as it progresses, patients may experience blood in urine, back pain, weight loss, and fatigue. The disease tends to grow slowly in its early stages but can become aggressive if left undetected.
Small Cell Lung Cancer
This is an aggressive type of lung cancer that grows and spreads more rapidly than non-small cell lung cancer. The disease develops when cells in the lungs begin to multiply uncontrollably, forming tumors that can quickly grow in size. It has a strong tendency to spread early to other parts of the body, including the brain, liver, and bones. Most cases are closely linked to cigarette smoking and are rarely found in people who have never smoked. Symptoms include persistent cough, chest pain, shortness of breath, hoarseness, and unexplained weight loss. The cancer cells are smaller in size when viewed under a microscope, which gives the disease its name.
Head and Neck Cancer
This term refers to a group of cancers that develop in the mouth, throat, nose, sinuses, or salivary glands. These cancers typically begin in the cells that line the moist surfaces inside these areas. The disease usually starts as a single tumor that grows locally and can invade nearby tissues and structures. As it progresses, the cancer may spread to lymph nodes in the neck and eventually to distant organs. Symptoms vary depending on the location but may include a persistent sore throat, difficulty swallowing, changes in voice, a lump in the neck, or mouth sores that do not heal. The disease can affect breathing, eating, and speaking as it advances.
Bladder Carcinoma
This is a cancer that begins in the cells lining the inside of the bladder, the organ that stores urine. The disease most commonly starts in the innermost layer of the bladder wall and may remain superficial or grow deeper into the bladder muscle. As the cancer progresses, it can invade the muscular wall of the bladder and spread to nearby organs such as the prostate, uterus, or vagina. It may also spread to lymph nodes and distant organs through the bloodstream. The most common symptom is blood in the urine, which may appear red or cola-colored, along with frequent or painful urination. Some bladder cancers grow slowly and remain confined to the surface, while others are more aggressive and invasive.
Malignant Melanoma
This is a serious type of skin cancer that develops in melanocytes, the cells that produce pigment in the skin. The disease typically begins as an abnormal growth or change in an existing mole, appearing as a dark, irregularly shaped spot on the skin. Melanoma can grow downward into deeper layers of skin and has a strong tendency to spread to other parts of the body through the lymphatic system and bloodstream. Early changes may include variations in the color, size, shape, or texture of a mole or pigmented area. As it progresses, the tumor becomes thicker and penetrates deeper into the skin layers. The disease can occur anywhere on the body but is most common in areas exposed to the sun.