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)
Status: Recruiting
Location: See all (180) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participant must be ≥ 18 years at the time of screening
• Histologically proven diagnosis of pleural mesothelioma with known histology (epithelioid vs. non-epithelioid)
• Advanced unresectable disease that cannot be treated with curative surgery (with or without chemotherapy)
• WHO/ECOG performance status of 0 or 1 with no deterioration (that is, ECOG PS\>1) over the previous 2 weeks prior to day of first dosing
• Has measurable disease per modified RECIST1.1
• Has adequate bone marrow reserve and organ function at baseline
Locations
United States
Arizona
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Phoenix
California
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Duarte
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Santa Rosa
Colorado
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Aurora
Florida
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Jacksonville
Georgia
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Atlanta
Illinois
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Chicago
Maryland
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Baltimore
Minnesota
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Rochester
Missouri
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St Louis
New Jersey
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East Brunswick
New York
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Commack
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Valhalla
Ohio
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Cleveland
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Cleveland
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Cleveland
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Columbus
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Independence
Oregon
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Portland
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Portland
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Portland
Pennsylvania
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Philadelphia
Texas
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Houston
Virginia
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Fairfax
Other Locations
Australia
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Chermside
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Clayton
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Melbourne
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Nedlands
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Westmead
Belgium
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Anderlecht
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Antwerp
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Ghent
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Hasselt
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Leuven
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Sint-niklaas
Brazil
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Barretos
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Fortaleza
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João Pessoa
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Porto Alegre
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Rio De Janeiro
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Santo André
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São Paulo
Canada
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Edmonton
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Hamilton
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London
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Montreal
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Ottawa
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Québec
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Toronto
China
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Beijing
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Beijing
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Changchun
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Changsha
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Chengdu
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Chongqing
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Guangzhou
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Guangzhou
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Guangzhou
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Hangzhou
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Harbin
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Kunming
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Lanzhou
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Nanchang
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Ningbo
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Qingdao
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Shandong
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Shanghai
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Shenyang
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Taiyuan
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Taiyuan
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Tianjin
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Tianjin
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Wuhan
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Xi'an
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Zhengzhou
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Zhengzhou
Denmark
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Aarhus N
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Copenhagen
France
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Brest
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Créteil
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Le Mans
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Lille
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Lyon
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Marseille
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Montpellier
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Paris
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Rouen
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Saint-herblain
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Strasbourg
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Toulouse
Germany
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Berlin
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Berlin
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Bochum
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Cologne
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Essen
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Essen
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Gauting
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Georgsmarienhütte
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Großhansdorf
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Hamburg
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Heidelberg
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Kiel
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Münster
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Regensburg
Italy
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Alessandria
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Bari
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Bergamo
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Milan
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Monza
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Orbassano
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Padua
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Parma
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Rozzano
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Varese
Japan
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Amagasaki-shi
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Hakodate-shi
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Hiroshima
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Kitaadachi-gun
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Kitakyushu-shi
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Matsuyama
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Nagoya
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Nishinomiya-shi
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Okayama
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Osakasayama-shi
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Tokyo
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Ube-shi
Netherlands
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Amsterdam
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Eindhoven
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Rotterdam
Norway
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Lørenskog
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Oslo
Poland
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Bydgoszcz
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Bystra
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Olsztyn
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Poznan
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Rzeszów
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Warsaw
Republic of Korea
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Cheongju-si
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Seoul
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Seoul
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Seoul
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Ulsan
South Africa
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Cape Town
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Emanzimtoti
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Johannesburg
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SUSPENDED
Johannesburg
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Kimberly
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Polokwane
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Pretoria
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Pretoria
Spain
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Barakaldo
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Barcelona
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Madrid
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Oviedo
Switzerland
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Baden
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Basel
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Bern
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Fribourg
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Sankt Gallen
Taiwan
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Kaohsiung City
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Taichung
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Tainan City
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Taipei
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Taoyuan District
Turkey
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Adana
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Ankara
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SUSPENDED
Ankara
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Diyarbakır
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Izmir
United Kingdom
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Cambridge
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Cardiff, Wales
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Leeds
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Leicester
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London
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London
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London
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Manchester
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Newcastle Upon Tyne
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Portsmouth
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Taunton
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2023-11-09
Estimated Completion Date: 2028-03-13
Participants
Target number of participants: 825
Treatments
Experimental: Volrustomig + Carboplatin + pemetrexed
Volrustomig in combination with carboplatin plus pemetrexed
Active_comparator: Investigator's choice of standard care
The investigator's choice of nivolumab plus ipilimumab or platinum plus pemetrexed chemotherapy for participants with epithelioid histology, and nivolumab plus ipilumab for participants with non-epithelioid histology.
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca