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Study of Tremelimumab for Patients with Unresectable Malignant Mesothelioma

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What is this study about?

This clinical trial is focused on studying a disease called unresectable malignant mesothelioma, which affects the lining of the lungs or abdomen. The study is testing a treatment called Tremelimumab, which is given as a solution through an infusion, meaning it is delivered directly into the bloodstream. The trial will compare the effects of Tremelimumab to a placebo, which is a substance with no active medication, to see if Tremelimumab can help improve the survival of patients with this type of mesothelioma.

The purpose of the study is to understand if Tremelimumab can help people live longer when they have this type of cancer that cannot be removed by surgery. Participants in the study will receive either Tremelimumab or a placebo, and their health will be monitored over time to see how they respond to the treatment. The study will last for a period of up to 36 months, during which participants will have regular check-ups and tests to track their progress and any side effects they might experience.

Throughout the study, researchers will also look at other important factors, such as how the treatment affects the quality of life and any potential side effects. The study aims to provide valuable information about the safety and effectiveness of Tremelimumab for treating unresectable malignant mesothelioma, which could help improve future treatment options for this challenging condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, previous treatments, and health status.

Written informed consent is required before any study-related procedures begin.

2 randomization

Participants are randomly assigned to receive either tremelimumab or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

3 treatment administration

Tremelimumab is administered as a solution for infusion. The dosage and frequency are determined by the study protocol.

Participants receiving the placebo will undergo the same infusion process without the active medication.

4 monitoring and follow-up

Regular monitoring is conducted to assess health status, including clinical laboratory evaluations, electrocardiograms (ECGs), and vital signs.

Adverse events and serious adverse events are recorded and evaluated for severity and potential relation to the treatment.

5 evaluation of outcomes

The primary outcome measured is overall survival, defined as the time from randomization until death from any cause.

Secondary outcomes include survival rate at 18 months, disease control rate, progression-free survival, and overall response rate.

6 end of study

The study is estimated to conclude by June 30, 2025, at which point all data will be analyzed to determine the effectiveness and safety of tremelimumab compared to placebo.

Who Can Join the Study?

  • The patient must have a confirmed diagnosis of pleural or peritoneal malignant mesothelioma. This means the disease is in the lining of the lungs or abdomen and cannot be removed by surgery.
  • Women who can have children and are sexually active with a male partner must use a very effective form of birth control for 28 days before starting the study treatment and continue for 6 months after the last dose.
  • Men who are not sterilized and are sexually active with a woman who can have children must use a very effective form of birth control from the first day of treatment until 90 days after the last dose.
  • The patient must be 18 years or older at the time they agree to participate.
  • The patient must have an ECOG Performance status of 0-1, which means they are fully active or have some symptoms but can still do light work.
  • The patient must have had 1-2 previous treatments for advanced disease, including a first-line treatment with pemetrexed (a type of chemotherapy) combined with a platinum agent (another type of chemotherapy).
  • The patient must have recovered from any side effects of previous treatments.
  • The patient must have a disease that can be measured by doctors.
  • The patient must have adequate function of the bone marrow, liver, and kidneys.
  • The patient must test negative for HIV and hepatitis A, B, and C.
  • The patient must provide written informed consent, which means they agree to participate in the study and understand what it involves.

Who Cannot Join the Study?

  • Patients who have had another type of cancer in the past, unless it was a type that is not likely to come back.
  • Patients who have a serious infection that is not under control.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a condition that affects their immune system, which is the body’s defense system against illnesses.
  • Patients who are taking medications that weaken the immune system.
  • Patients who have had an organ transplant, like a kidney or liver transplant.
  • Patients who have a history of severe allergic reactions to similar treatments.
  • Patients who have a condition that affects the brain or nervous system.
  • Patients who have a heart condition that is not stable.
  • Patients who have a lung condition that is not stable.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Centro Di Riferimento Oncologico Di Aviano Aviano Italy

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

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
07.12.2012

Trial locations

Investigated drugs:

Tremelimumab is a medication being studied for its potential to treat malignant mesothelioma, a type of cancer that affects the lining of the lungs or abdomen. It works by helping the immune system recognize and attack cancer cells. In this clinical trial, tremelimumab is being compared to a placebo to see if it can improve the survival of patients who have already received other treatments.

Unresectable Pleural or Peritoneal Malignant Mesothelioma – This is a type of cancer that affects the lining of the lungs (pleura) or the abdomen (peritoneum). It is termed “unresectable” because it cannot be removed completely through surgery. The disease is often linked to asbestos exposure and progresses as cancer cells grow and spread in the affected lining. Symptoms may include chest pain, shortness of breath, or abdominal swelling, depending on the location. As the disease advances, it can lead to more severe respiratory or digestive issues. The progression is typically slow, but it can vary based on individual factors.

Trial ID:
2024-511841-20-00
Protocol code:
D4880C00003
NCT ID:
NCT01843374
Trial Phase:
Therapeutic exploratory (Phase II)

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