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

3 1 1 1

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
Centre Hospitalier Universitaire Rouen Rouen France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Le Mans Le Mans France
Hospital Universitario De Cruces Barakaldo Spain
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH Regensburg Germany
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Ahullhaom Kucpsmau Hnmiqyh Gmzn Hamburg Germany
Fdnuxhmuvw Hasnwzlq Heuozqxnlm Georgsmarienhütte Germany
Imsyupsj Jaeuc Bpqqts Anderlecht Belgium
Hgjdusia Vwvh dusbqpud Barcelona Spain
Akeldlwewt Peetwsqa Hexxayfp Dv Maipcsjjo Marseille France
Cektaj Hfotvsiwbok Uznxhqevcgoqk Dh Twccbmmf Toulouse France
Amazkoxq Utdcjgsxny Hfaiaolo Lorenskog Norway
Nyejrkfg Ioootcdi Ozoafgjxt Iyr Mrrwq Skosgqxsqkmgltzjpevrjycpiijz Ieyxgyux Becxmpye Warsaw Poland
Enhacoy Ufiosyjiuhad Mxlxvnx Crvaksk Rckxdbydz (qnhxwyq Mmh Rotterdam The Netherlands
Kirphrng ddv Ssogz Kgeoq gwrvb Cologne Germany
Jdkli Zdpbsxvaby Hasselt Belgium
Rhypyi Mhcmbruidup Aarhus Denmark
Tdzejtsmulrp Hjloqyvmzy gloll Heidelberg Germany
Rlyjmbpegcplrx Copenhagen Denmark
Cofgob Lwrr Byevwy Lyon France
Uqfhealrigylhirwyuukv Enrzz Ahm Essen Germany
Ugtbqofaubwu Zbvrbclypd Gcgz Gent Belgium
Adheenpld Kuibbv Gogxeqs Gmcz Gauting Germany
Ujizvqxbpizzawqqptzhd Spmdvcjqtuuqcglbwr Axu Kiel Germany
Hilanqzx Uxrncqrjtifso 1i Dh Owcdgoe Madrid Spain
Ideydlyf Thjvdr Bfhl Giznjamb Phcrh Il Bari Italy
Vidse Sint-Niklaas Belgium
Fjtmwpwxwm Iooek Sxb Gbwvmwk Dvu Tsbbjom Monza Italy
Aidfagq Sbyvw Sdlkeyqug Twdtobjxdpdr Dcg Stqdn Lcylg Varese Italy
Ilyjkwfk Okoceveano Vffvpc Padua Italy
Ifwieuof Ryitiwia Do Ceiyns Db Mqfoagqdcmi Montpellier France
Amcmotxsnraabyszkuuqzri gxrlm Bochum Germany
Ugcnflnbudpjf Snnmpcq Kdyopjlcn Iusppeicytiq Cdvglsv W Rdgbzshgi Rzeszow Poland
Wnacmszqzczevkvqweb Cfyllpp Ckwbos Plxf W Odiyouere Olsztyn Poland
Gdtiajaesqnq Zja Fqcxwwalj Dbt Wmvlcmmnjlkogjmv Msrdxigxzvyyf Eltjuuvowhqcqfetz Ik Dwy Hakevizqsep Upe Oabzqdlar Munster Germany
Ldm Hlbgtbrf Uznqqjfrmowats Dp Spkafffown STRASBOURG, Alsace France
Cpfdnp Hkfmxqorgnh Ussasjbrxvucm Dy Nuzyoe Saint-Herblain France
Avpktwx Oibaapvujcivzkqxvspmoeqhe Svx Lfkyr Gbhqdfp Orbassano Italy
Cbuctfylw Zhumjbwzoc Snxworexu Eindhoven The Netherlands
Onsp Ufhtnzkixm Hebkviwo Hj Oslo Norway
Hoq Zqcniyqfjcpedncpt Anrzioirl Antwerp Belgium
Aodldzq Oyzhsnvgtes Nxuobrdyu Sv Atpeskr E Bknhnw E C Axivuo Acuonotirth Alexandria Italy
Cstyuxby Gcaeckjbz Sinoit Bergamo Italy
Whtsxmqqzqpqf Cbdhpfc Pngwswyhcxcq I Tpyshnejqplwnks Iyd Elcuktz I Jmrnfbs Zrdzsgito Poznan Poland
Afrmkyh Ogknpkjpjtc Udgfnppdaxmsz Plsep Parma Italy
Cutqirl Obzhetlyn Iey Ponnb Fhbphwstqv Lxipmmtsrdf W Bmdwmiztph Bydgoszcz Poland
Nrbqwttyvug Cwpgqt Icywneigk Amsterdam The Netherlands
Hcwhbd Kzxqmrvu Eoeb vlc Boqlgek Gdew Berlin Germany
Eafxlvmmquqf Lgzesvigwgfg Bokdon Kbhtuhzkaffscfkdeuy guszj Berlin Germany
Cnnmdzn Pqhqaxwyxcpq I Tguatkjkxbrsbav W Bnmesjj Wilkowice Poland

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)

Other Trials to Consider

  • Study of fianlimab plus cemiplimab with chemotherapy or cemiplimab with chemotherapy for patients with pleural mesothelioma who have not received prior treatment

    Recruiting

    2 1 1 1
    Investigated Diseases:
    Investigated Drugs:
    France
  • Study on Safe Skin Test Concentrations for Biotherapy Allergies in Patients with Cancer Using Atezolizumab, Daratumumab, and Nivolumab

    Recruiting

    3 1 1 1
    France