Study of Ivonescimab for Treating Relapsed Pleural Mesothelioma in Patients After Immunotherapy and Chemotherapy

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What is this study about?

This clinical trial is focused on evaluating a new treatment for patients with pleural mesothelioma, a type of cancer that affects the lining of the lungs. The study is investigating the use of a medication called ivonescimab, which is administered as an injection. Ivonescimab is a bispecific antibody, meaning it is designed to target two specific proteins involved in cancer growth. This trial is for patients whose cancer has returned after receiving previous treatments, including immunotherapy and standard chemotherapy.

The purpose of the study is to assess the potential benefits of ivonescimab as a second or third line of treatment for patients with relapsing pleural mesothelioma. Participants in the study will receive ivonescimab through an intravenous drip, which means the medication is delivered directly into the bloodstream. The study will also involve the use of standard chemotherapy as part of the treatment plan. The trial will last for a period of up to 24 months, during which the effects of the treatment will be closely monitored.

Throughout the study, researchers will evaluate how well the treatment controls the disease and monitor any side effects that may occur. The goal is to determine if ivonescimab can help manage pleural mesothelioma more effectively than current treatment options. This trial represents an important step in exploring new ways to treat this challenging condition and improve outcomes for patients.

1 joining the study

Upon joining the study, you will be required to provide a signed informed consent form. This form confirms your understanding of the study and your willingness to participate. It is important to comply with scheduled visits, treatment schedules, and laboratory testing.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying your diagnosis of pleural mesothelioma and ensuring that your disease has progressed after previous treatments. Your medical history and current health status will be reviewed.

3 treatment administration

You will receive the study medication, ivonescimab, through an intravenous drip. The dosage and frequency will be determined by the study protocol, and you will be informed of the specific schedule. The treatment aims to assess the therapeutic value of ivonescimab as a second or third line of treatment.

4 regular monitoring

Throughout the study, regular monitoring will be conducted to assess your response to the treatment. This includes physical examinations, blood tests, and imaging studies such as CT scans. The goal is to evaluate the disease control rate at 12 weeks and monitor any side effects.

5 follow-up visits

You will have follow-up visits with the study team to discuss your progress and any concerns. These visits are essential for tracking your health and the effectiveness of the treatment. The study will also assess progression-free survival and overall survival as part of the evaluation.

6 end of study participation

At the end of your participation in the study, a final assessment will be conducted. This will include a review of your overall health and any changes observed during the study. You will receive information on any further steps or treatments recommended based on the study findings.

Who Can Join the Study?

Must have signed an informed consent form, which means you agree to participate in the study and understand what it involves.
Must be willing and able to attend scheduled visits, follow the treatment plan, and undergo necessary tests.
Must have a confirmed diagnosis of pleural mesothelioma through a biopsy, which is a small sample of tissue taken for testing.
Must show disease progression on a CT scan, a type of detailed imaging test, after receiving certain treatments.
Must have a measurable disease according to specific criteria used for mesothelioma.
Must have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but do not need bed rest during the day.
Must not have lost more than 10% of your body weight in the last 3 months.
Must be 18 years of age or older.
Must have a life expectancy of more than 3 months.
Must have available tissue samples from a previous biopsy for further testing.
Must have adequate biological functions, including:
- Creatinine clearance of at least 45 mL/min, which measures kidney function.
- Neutrophils of at least 1500/mm³, which are a type of white blood cell important for fighting infections.
- Platelets of at least 100,000/mm³, which help with blood clotting.
- Hemoglobin of at least 9 g/dL, which is a protein in red blood cells that carries oxygen.
- AST and ALT less than 3 times the upper limit of normal (ULN), which are liver enzymes.
- Total bilirubin less than 2 times ULN, which is a substance made by the liver.
- Urine protein less than 2+ or 24-hour urine protein quantification less than 1.0 g, which checks for protein in the urine.
- Prothrombin time (PT) or international normalized ratio (INR) less than 1.5 times ULN, which measures blood clotting.
- Partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) less than 1.5 times ULN, which also measures blood clotting.
Women of childbearing potential must use a highly effective method of contraception starting 28 days before the first dose and continuing for 6 months after the last dose. They must also have a negative pregnancy test before starting the study.
Men who are sexually active with women of childbearing potential must use an effective method of contraception during the study and for 6 months after the last dose.
Must be covered by national health insurance.

Who Cannot Join the Study?

Patients with any other type of cancer besides pleural mesothelioma cannot participate.
Patients who have received certain treatments for their cancer recently may not be eligible.
Patients with severe heart problems or uncontrolled high blood pressure are excluded.
Patients with active infections that require treatment cannot join the study.
Patients who are pregnant or breastfeeding are not allowed to participate.
Patients with a history of severe allergic reactions to similar medications are excluded.
Patients with certain autoimmune diseases, where the immune system attacks the body, may not be eligible.
Patients who have participated in another clinical trial recently may not be eligible.
Patients with severe liver or kidney disease are excluded.
Patients who are unable to follow the study procedures or attend study visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Jean Perrin	Clermont Ferrand	France
Centre Hospitalier Intercommunal Creteil	Creteil	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer	Toulon	France
Centre Hospitalier Le Mans	Le Mans	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopitaux Prives De Metz	Vantoux	France
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace	Mulhouse	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Ajzuctfohs Pxlynmof Hfhefvir De Msqpouffo	Marseille	France
Bobvmrpg Uihsteqfpj Hkkvxzny Crhhtv	Besançon	France
Cafyrf Hpxwcnzkyaz Rxnoayao Uceooisbkwrro Ds Tmzki	Tours	France
Hzzykyvt Upxshbbaouzpxj Seedtapbew &vrbtsd Hlytsqq dx Hvbaighltgh	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.03.2025

Trial locations

Investigated drugs:

Ivonescimab

Ivonescimab is a special type of medication known as a bispecific antibody. It is designed to help treat a condition called pleural mesothelioma, which affects the lining of the lungs. This medication works by targeting two specific proteins in the body: VEGF and PD-1. By blocking these proteins, ivonescimab can help stop the growth of cancer cells and boost the immune system’s ability to fight the cancer. It is used in patients whose cancer has returned after previous treatments with immunotherapy and standard chemotherapy. This trial is exploring how effective ivonescimab is as a second or third line of treatment for these patients.

Investigated diseases:

Pleural mesothelioma malignant

Pleural Mesothelioma – Pleural mesothelioma is a type of cancer that develops in the thin layer of tissue surrounding the lungs, known as the pleura. It is primarily caused by exposure to asbestos fibers, which can be inhaled and become lodged in the pleura. Over time, these fibers can cause inflammation and scarring, leading to the development of cancerous cells. The disease typically progresses slowly, with symptoms often appearing decades after exposure. As it advances, pleural mesothelioma can cause chest pain, shortness of breath, and fluid buildup around the lungs. The progression of the disease can lead to further complications as the cancerous cells spread to other parts of the body.

Trial ID:

2024-519052-82-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Ivonescimab for Treating Relapsed Pleural Mesothelioma in Patients After Immunotherapy and Chemotherapy

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