MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma
NCT ID: NCT06097728
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
825 participants
INTERVENTIONAL
2023-11-09
2028-11-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Volrustomig + Carboplatin + pemetrexed
Volrustomig in combination with carboplatin plus pemetrexed
Volrustomig
MEDI5752: Administered as IV infusion
Pemetrexed
Alimta: Administered as IV infusion
Carboplatin
Paraplatin: Administered as IV infusion
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.
Pemetrexed
Alimta: Administered as IV infusion
Carboplatin
Paraplatin: Administered as IV infusion
Cisplatin
Platinol: Administered as IV infusion
Nivolumab
Opdivo: Administered as IV infusion
Ipilimumab
Yervoy: Administered as IV infusion
Interventions
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Volrustomig
MEDI5752: Administered as IV infusion
Pemetrexed
Alimta: Administered as IV infusion
Carboplatin
Paraplatin: Administered as IV infusion
Cisplatin
Platinol: Administered as IV infusion
Nivolumab
Opdivo: Administered as IV infusion
Ipilimumab
Yervoy: Administered as IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Active or prior documented autoimmune or inflammatory disorders
* History of another primary malignancy with exceptions.
* Uncontrolled intercurrent illness
* Tuberculosis, hepatitis B (HBV) or hepatitis C (HCV), human immunodeficiency virus (HIV) infection that is not well controlled
* Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment
* Untreated or progressive CNS metastatic disease
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Marjorie G Zauderer, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Slone Kettering (MSK) Cancer Centre
Arnaud Scherpereel, MD
Role: PRINCIPAL_INVESTIGATOR
Lille University
Locations
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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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Guangzhou, , 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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Padua, , 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 District, , 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
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
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2023-503231-17-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-000067-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D7988C00001
Identifier Type: -
Identifier Source: org_study_id