Study of Volrustomig with Carboplatin and Pemetrexed for Patients with Unresectable Pleural Mesothelioma

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What is this study about?

This clinical trial is focused on studying a disease called unresectable pleural mesothelioma, which is a type of cancer that affects the lining of the lungs and cannot be removed through surgery. The study is testing a new treatment option that combines a medication called volrustomig (also known by its code name MEDI5752) with two other drugs, carboplatin and pemetrexed. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. The trial will compare this new combination treatment to other standard treatments, which include either a combination of nivolumab and ipilimumab or a combination of platinum-based drugs with pemetrexed.

The purpose of the study is to determine if the new treatment combination is more effective in improving the overall survival of patients with pleural mesothelioma compared to the standard treatments. Participants in the study will receive one of the treatment options and will be monitored over time to assess their response to the treatment and any side effects they may experience. The study will also look at other factors such as how long the treatment works, the time it takes for the disease to progress, and the overall response rate to the treatment.

Throughout the study, participants will undergo regular check-ups, which may include physical exams, blood tests, and other assessments to monitor their health and the effects of the treatment. The trial aims to provide valuable information that could lead to better treatment options for people with pleural mesothelioma in the future.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of pleural mesothelioma, and overall health status.

The study involves participants with advanced pleural mesothelioma that cannot be treated with surgery.

2 randomization

Participants are randomly assigned to one of the treatment groups.

The study compares the effectiveness of different treatment combinations.

3 treatment administration

Participants receive treatments through intravenous use or orally, depending on the assigned group.

One group receives volrustomig in combination with carboplatin and pemetrexed.

Another group receives a combination of nivolumab and ipilimumab or a combination of platinum and pemetrexed.

4 monitoring and assessments

Participants undergo regular monitoring to assess overall survival and progression-free survival.

Additional assessments include response rate, duration of response, and safety evaluations.

5 follow-up

Participants continue to be monitored for overall survival and any changes in disease-related symptoms.

The study aims to collect data on the long-term effects and safety of the treatments.

Who Can Join the Study?

  • The participant must be at least 18 years old at the time of screening.
  • The participant must have a confirmed diagnosis of pleural mesothelioma, which is a type of cancer affecting the lining of the lungs, with a known type (either epithelioid or non-epithelioid).
  • The disease must be advanced and cannot be removed by surgery aimed at curing it, with or without chemotherapy.
  • The participant must have a WHO/ECOG performance status of 0 or 1. This means they should be fully active or have some symptoms but be able to carry out light work, with no worsening of their condition in the two weeks before starting the treatment.
  • The participant must have a disease that can be measured using a specific method called modified RECIST1.1.
  • The participant must have enough healthy bone marrow and properly working organs at the start of the study.

Who Cannot Join the Study?

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who have had another type of cancer in the past, unless it was treated and has not come back for a certain period.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had an allergic reaction to any of the study drugs or similar drugs in the past.
  • Patients with certain infections that are not well controlled.
  • Patients who have received certain treatments for their condition recently, which might affect the study results.
  • Patients with a history of drug or alcohol abuse that could interfere with the study.
  • Patients who have had a major surgery recently.
  • Patients with certain heart conditions that are not well controlled.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Centre Hospitalier Le Mans Le Mans France
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Hospital Universitario De Cruces Barakaldo Spain
Oslo University Hospital HF Oslo Norway
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow Poznan Poland
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
HELIOS Klinikum Emil von Behring GmbH Berlin Germany
Vitaz Sint-Niklaas Belgium
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Kliniken der Stadt Koeln gGmbH Cologne Germany
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH Regensburg Germany
Istituto Oncologico Veneto Padua Italy
Franziskus Hospital Harderberg Georgsmarienhütte Germany
Centre Hospitalier Universitaire Rouen Rouen France
Institut Jules Bordet Anderlecht Belgium
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie Munster Germany
Les Hopitaux Universitaires De Strasbourg STRASBOURG, Alsace France
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire De Toulouse Toulouse France
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Jessa Ziekenhuis Hasselt Belgium
Cliniche Gavazzeni S.p.A. Bergamo Italy
Region Midtjylland Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Netherlands Cancer Institute Amsterdam The Netherlands
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Universitair Ziekenhuis Gent Gent Belgium
Asklepios Klinik Gauting GmbH Gauting Germany
Hospital Universitario 12 De Octubre Madrid Spain
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Berlin Germany
Centrum Pulmonologii I Torakochirurgii W Bystrej Wilkowice Poland
Centre Hospitalier Universitaire De Nantes Saint-Herblain France
Aegkpnq Onxhzuauksl Nezpzsgan Sc Azjbucg E Bhyvcb E C Axwgea Adoiassbaiy Alexandria Italy
Uzcxyelqmjspvcqmdhoci Ejlag Apz Essen Germany
Aqumcefiahpnehmpoleosbx gnbyq Bochum Germany
Hlz Zudvqkamuiovlhfvg Anydfoeci Antwerp Belgium
Ikgtiacb Rjnklfhy Dk Cvcywo Dc Mkzapwotjjp Montpellier France
Aoraktyjwf Pxgydbdt Htkzidqq Dm Mjpivwbqz Marseille France
Aqtkufmg Ufpuxhsokn Havtstyp Lorenskog Norway
Eistscx Ufnzymrysnkm Mvwlbde Cgjhnda Rbynnijgt (cntjacp Mqz Rotterdam The Netherlands
Aupaifc Ohenbyegqvd Uuumdzxqafuxh Plwcp Parma Italy
Cqweox Lugv Bnrihq Lyon France
Hnwokusm Vqgx ddqbwebj Barcelona Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.03.2024
Denmark Denmark
Not recruiting
01.03.2024
France France
Not recruiting
01.03.2024
Germany Germany
Not recruiting
01.03.2024
Italy Italy
Not recruiting
01.03.2024
Norway Norway
Not recruiting
01.03.2024
Poland Poland
Not recruiting
01.03.2024
Spain Spain
Not recruiting
01.03.2024
The Netherlands The Netherlands
Not recruiting
01.03.2024

Trial locations

Volrustomig (MEDI5752) is an investigational medication being studied for its potential to treat pleural mesothelioma. It is being tested in combination with other cancer treatments to see if it can improve survival rates in patients with this type of cancer.

Carboplatin is a chemotherapy drug used to treat various types of cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing.

Pemetrexed is another chemotherapy medication that is often used in combination with other drugs to treat certain types of lung cancer, including pleural mesothelioma. It works by blocking the cancer cells’ ability to use folate, which is necessary for their growth.

Nivolumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It is used to treat various types of cancer by blocking a protein that prevents the immune system from attacking cancer cells.

Ipilimumab is also an immunotherapy medication that works by activating the immune system to fight cancer. It is often used in combination with other drugs to enhance the body’s ability to target and destroy cancer cells.

Investigated diseases:

Unresectable Pleural Mesothelioma – This is a type of cancer that occurs in the thin layer of tissue covering the lungs and chest wall, known as the pleura. It is termed “unresectable” when the tumor cannot be removed through surgery. The disease is primarily caused by exposure to asbestos fibers, which can lead to the development of cancerous cells in the pleura. As the disease progresses, it can cause symptoms such as chest pain, shortness of breath, and fluid buildup around the lungs. The cancer cells can spread to nearby tissues and organs, making it challenging to manage. Over time, the disease can significantly impact lung function and overall health.

Trial ID:
2023-503231-17-00
Protocol code:
D7988C00001
Trial Phase:
Therapeutic confirmatory (Phase III)

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