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Study on Immune Markers for Checkpoint Inhibitor Toxicity in Cancer Patients Using Atezolizumab, Dexamethasone Sodium Phosphate, and Alizapride

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What is this study about?

This clinical trial is focused on studying the effects of certain medications on patients with solid tumors, which are abnormal masses of tissue that usually do not contain cysts or liquid areas. The study involves the use of medications known as immune checkpoint inhibitors (ICIs), which are treatments that help the immune system recognize and attack cancer cells. Some of the ICIs being studied include atezolizumab, durvalumab, nivolumab, ipilimumab, pembrolizumab, avelumab, and cemiplimab. These medications are often used alone or in combination with other treatments like chemotherapy or targeted therapy.

The purpose of this study is to explore the value of immune markers present in the blood to identify biomarkers for immune-related toxicities of these checkpoint inhibitors. This means researchers are looking for specific signs in the blood that might predict how a patient will react to the treatment. The study will monitor changes in these immune markers at different times during the treatment and when any immune-related side effects occur. The study will also assess the safety of these treatments by recording any adverse events, which are any unwanted effects experienced by participants during the study.

Participants in the study will receive the treatments over a period of up to 12 months. The medications are administered through an intravenous infusion, which means they are given directly into a vein. The study aims to gather information that could help improve the understanding of how these treatments work and how they might cause side effects, ultimately leading to better care for patients with solid tumors.

1 enrollment

Upon joining the clinical trial, you will be required to complete all necessary screening procedures within 14 days prior to enrollment. This includes confirming that you meet the eligibility criteria, such as being 18 years or older, having a confirmed solid tumor, and having a performance status of 1 or less on the ECOG scale, which measures your ability to perform daily activities.

You must also ensure that any previous treatment-related side effects are mild, and if you are of childbearing potential, a negative pregnancy test is required within 15 days before starting the study medications. You will need to sign an informed consent form to confirm your understanding and agreement to participate in the study.

2 treatment initiation

The treatment phase begins with the administration of immune checkpoint inhibitors (ICIs), which are medications designed to help your immune system fight cancer. Depending on your specific treatment plan, you may receive ICIs alone, in combination with chemotherapy, or with targeted therapy.

The medications are administered intravenously, meaning they are given through a vein. The specific drugs and their combinations will be determined based on your treatment group within the study.

3 monitoring and assessments

Throughout the trial, your health and response to the treatment will be closely monitored. This includes regular blood tests to measure immune markers, which are substances in your blood that can indicate how your immune system is responding to the treatment.

These assessments will occur at three different time points: early, mid, and late in the treatment process. Additionally, any side effects or adverse events will be recorded and evaluated according to the National Cancer Institute’s criteria.

4 completion and follow-up

Once the treatment phase is completed, there will be a follow-up period to continue monitoring your health and any long-term effects of the treatment. This may include additional blood tests and health assessments.

You will be informed about the results of the trial and any relevant findings that may impact your future care.

Who Can Join the Study?

  • Must be 18 years old or older.
  • Must have an ECOG performance status of 0 or 1. This is a scale used to assess how a disease affects a patient’s daily living abilities, where 0 means fully active and 1 means restricted in physically strenuous activity but able to carry out light work.
  • Must have a confirmed solid tumour and be eligible for treatment with immune checkpoint inhibitors (ICI) either alone or in combination with other treatments like chemotherapy or targeted therapy.
  • All previous treatment-related side effects, except for hair loss, must be at a mild level (Grade 1) at the time of joining the study.
  • If you are a woman who can become pregnant, you must have a negative pregnancy test within 15 days before starting the study medications.
  • Women who can become pregnant must agree to use a highly effective method of birth control before starting the study, during the study, and for at least 7 months after the last study treatment.
  • Men with partners who can become pregnant must agree to use a condom during the study and for at least 6 months after the last study treatment.
  • All necessary screening tests must be completed within 14 days before joining the study.
  • You must sign an Informed Consent Form (ICF) before any study-related procedures. This form explains the study and confirms your agreement to participate.

Who Cannot Join the Study?

  • Patients who do not have a solid tumor. A solid tumor is a mass of tissue that forms when cells grow uncontrollably.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial group.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Institut Jules Bordet Anderlecht Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.07.2022

Trial locations

Investigated drugs:

I’m sorry, but the provided data does not contain specific information about the medications or therapies involved in the clinical trial. If you have more detailed information or another source, please provide it so I can assist you further.

Solid Tumor – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs, muscles, and bones. The progression of solid tumors involves the growth and multiplication of abnormal cells, which can invade nearby tissues. Over time, these tumors may grow larger and potentially spread to other parts of the body through the bloodstream or lymphatic system. The rate of progression can vary widely depending on the type of tumor and its location. Solid tumors are distinct from blood-related cancers, such as leukemia, which do not form solid masses.

Trial ID:
2023-505360-11-00
Protocol code:
IJB-IRAES-2020
Trial Phase:
Therapeutic exploratory (Phase II)

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