RecruitingPhase 3NCT06097728

MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

A Phase III, Randomized, Open-Label, Multicenter, Global Study of Volrustomig (MEDI5752) in Combination With Carboplatin Plus Pemetrexed Versus Platinum Plus Pemetrexed or Nivolumab Plus Ipilimumab in Participants With Unresectable Pleural Mesothelioma (eVOLVE-Meso)

Sponsor

AstraZeneca

Enrollment

825 participants

Start Date

Nov 9, 2023

Study Type

INTERVENTIONAL

Conditions

Unresectable Pleural Mesothelioma

Summary

This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of Volrustomig (MEDI5752) + Carboplatin + Pemetrexed vs the investigator's choice of platinum + Pemetrexed or Nivolumab + Ipilimumab in participants with unresectable pleural mesothelioma.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination treatment — MEDI5752 (a drug that blocks two immune checkpoints at once, PD-1 and CTLA-4) together with standard chemotherapy (carboplatin and pemetrexed) — for people with unresectable (inoperable) pleural mesothelioma, a cancer that affects the lining around the lungs. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with pleural mesothelioma confirmed by biopsy - Your disease cannot be removed by surgery - You are in good overall health (ECOG performance status 0 or 1 — active and able to carry out daily activities) - You have measurable disease on imaging - Your blood counts, liver, and kidney function are adequate **You may NOT be eligible if...** - You have active or prior autoimmune or inflammatory conditions - You have another active cancer - You have untreated or actively worsening brain metastases - You are currently on chemotherapy, radiation, or other cancer treatments - You have uncontrolled infections (including HIV, Hepatitis B, Hepatitis C, or tuberculosis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVolrustomig

MEDI5752: Administered as IV infusion

DRUGPemetrexed

Alimta: Administered as IV infusion

DRUGCarboplatin

Paraplatin: Administered as IV infusion

DRUGCisplatin

Platinol: Administered as IV infusion

DRUGNivolumab

Opdivo: Administered as IV infusion

DRUGIpilimumab

Yervoy: Administered as IV infusion

Locations(178)

Research Site

Phoenix, Arizona, United States

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Duarte, California, United States

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Santa Rosa, California, United States

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Aurora, Colorado, United States

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Jacksonville, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Baltimore, Maryland, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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East Brunswick, New Jersey, United States

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Commack, New York, United States

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Valhalla, New York, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Independence, Ohio, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Houston, Texas, United States

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Fairfax, Virginia, United States

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Chermside, Australia

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Clayton, Australia

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Melbourne, Australia

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Nedlands, Australia

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Westmead, Australia

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Anderlecht, Belgium

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Antwerp, Belgium

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Ghent, Belgium

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Hasselt, Belgium

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Leuven, Belgium

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Sint-Niklaas, Belgium

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Barretos, Brazil

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Fortaleza, Brazil

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João Pessoa, Brazil

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Porto Alegre, Brazil

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Rio de Janeiro, Brazil

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Santo André, Brazil

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São Paulo, Brazil

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Edmonton, Alberta, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Beijing, China

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Beijing, China

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Changchun, China

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Changsha, China

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Chengdu, China

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Chongqing, China

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Guangzhou, China

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Hangzhou, China

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Harbin, China

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Kunming, China

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Lanzhou, China

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Nanchang, China

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Ningbo, China

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Qingdao, China

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Shandong, China

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Shanghai, China

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Shenyang, China

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Taiyuan, China

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Taiyuan, China

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Tianjin, China

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Tianjin, China

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Wuhan, China

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Xi'an, China

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Zhengzhou, China

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Zhengzhou, China

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Aarhus N, Denmark

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Copenhagen, Denmark

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Brest, France

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Créteil, France

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Le Mans, France

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Lille, France

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Lyon, France

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Marseille, France

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Montpellier, France

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Paris, France

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Rouen, France

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Saint-Herblain, France

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Strasbourg, France

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Toulouse, France

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Berlin, Germany

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Berlin, Germany

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Bochum, Germany

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Cologne, Germany

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Essen, Germany

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Essen, Germany

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Gauting, Germany

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Georgsmarienhütte, Germany

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Großhansdorf, Germany

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Hamburg, Germany

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Heidelberg, Germany

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Kiel, Germany

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Münster, Germany

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Regensburg, Germany

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Alessandria, Italy

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Bari, Italy

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Bergamo, Italy

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Milan, Italy

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Monza, Italy

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Orbassano, Italy

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Padova, Italy

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Parma, Italy

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Rozzano, Italy

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Varese, Italy

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Amagasaki-shi, Japan

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Hakodate-shi, Japan

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Hiroshima, Japan

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Kitaadachi-gun, Japan

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Kitakyushu-shi, Japan

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Matsuyama, Japan

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Nagoya, Japan

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Nishinomiya-shi, Japan

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Okayama, Japan

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Osakasayama-shi, Japan

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Tokyo, Japan

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Ube-shi, Japan

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Amsterdam, Netherlands

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Eindhoven, Netherlands

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Rotterdam, Netherlands

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Lørenskog, Norway

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Oslo, Norway

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Bydgoszcz, Poland

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Bystra, Poland

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Olsztyn, Poland

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Poznan, Poland

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Rzeszów, Poland

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Warsaw, Poland

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Cape Town, South Africa

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eManzimtoti, South Africa

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Johannesburg, South Africa

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Johannesburg, South Africa

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Kimberly, South Africa

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Polokwane, South Africa

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Pretoria, South Africa

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Pretoria, South Africa

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Cheongju-si, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Ulsan, South Korea

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Barakaldo, Spain

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Barcelona, Spain

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Madrid, Spain

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Oviedo, Spain

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Baden, Switzerland

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Basel, Switzerland

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Bern, Switzerland

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Fribourg, Switzerland

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Sankt Gallen, Switzerland

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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Adana, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Diyarbakır, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Cambridge, United Kingdom

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Cardiff, Wales, United Kingdom

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Leeds, United Kingdom

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Leicester, United Kingdom

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London, United Kingdom

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London, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Newcastle upon Tyne, United Kingdom

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Portsmouth, United Kingdom

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Taunton, United Kingdom

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NCT06097728