MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

NCT ID: NCT06097728

Last Updated: 2025-11-14

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

825 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-09

Study Completion Date

2028-11-16

Brief Summary

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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.

Detailed Description

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Adult patients with histologically proven diagnosis of pleural mesothelioma with advanced unresectable disease are eligible to be enrolled. Patients will be randomized 1:1 to receive Volrustomig (MEDI5752) + Carboplatin + Pemetrexed or the investigator's choice of platinum+Pemetrexed or Nivolumab+Ipilimumab, based on their histology.

Conditions

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Unresectable Pleural Mesothelioma

Keywords

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Mesothelioma Pleural Mesothelioma Unresectable Pleural Mesothelioma Advanced pleural mesothelioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized, open-label, Phase III trial in participants with untreated unresectable pleural mesothelioma. Approximately 825 participants across histology subtypes will be randomized in a 1:1 ratio to receive volrustomig in combination with carboplatin plus pemetrexed or 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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
This is an open-label study for the personnel at study sites; the specific treatment to be taken by a participant will be assigned using an Interactive Response Technology/Randomization and Trial Supply Management. To maintain the integrity of the study, AstraZeneca personnel directly involved in the study conduct will not undertake or have access to efficacy data aggregated by treatment arm prior to final data readout for the primary endpoint.

Study Groups

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Volrustomig + Carboplatin + pemetrexed

Volrustomig in combination with carboplatin plus pemetrexed

Group Type EXPERIMENTAL

Volrustomig

Intervention Type DRUG

MEDI5752: Administered as IV infusion

Pemetrexed

Intervention Type DRUG

Alimta: Administered as IV infusion

Carboplatin

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Pemetrexed

Intervention Type DRUG

Alimta: Administered as IV infusion

Carboplatin

Intervention Type DRUG

Paraplatin: Administered as IV infusion

Cisplatin

Intervention Type DRUG

Platinol: Administered as IV infusion

Nivolumab

Intervention Type DRUG

Opdivo: Administered as IV infusion

Ipilimumab

Intervention Type DRUG

Yervoy: Administered as IV infusion

Interventions

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Volrustomig

MEDI5752: Administered as IV infusion

Intervention Type DRUG

Pemetrexed

Alimta: Administered as IV infusion

Intervention Type DRUG

Carboplatin

Paraplatin: Administered as IV infusion

Intervention Type DRUG

Cisplatin

Platinol: Administered as IV infusion

Intervention Type DRUG

Nivolumab

Opdivo: Administered as IV infusion

Intervention Type DRUG

Ipilimumab

Yervoy: Administered as IV infusion

Intervention Type DRUG

Other Intervention Names

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MEDI5752 Alimta Paraplatin Platinol Opdivo Yervoy

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* As judged by the investigator, any condition that would interfere with evaluation of the investigational product or interpretation of participant safety or study results.
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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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Research Site

Phoenix, Arizona, United States

Site Status WITHDRAWN

Research Site

Duarte, California, United States

Site Status WITHDRAWN

Research Site

Santa Rosa, California, United States

Site Status RECRUITING

Research Site

Aurora, Colorado, United States

Site Status RECRUITING

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Jacksonville, Florida, United States

Site Status RECRUITING

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Baltimore, Maryland, United States

Site Status NOT_YET_RECRUITING

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Rochester, Minnesota, United States

Site Status RECRUITING

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St Louis, Missouri, United States

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East Brunswick, New Jersey, United States

Site Status WITHDRAWN

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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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Research Site

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

Site Status SUSPENDED

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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)

Site Status SUSPENDED

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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

Site Status RECRUITING

Countries

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United States Australia Belgium Brazil Canada China Denmark France Germany Italy Japan Netherlands Norway Poland South Africa South Korea Spain Switzerland Taiwan Turkey (Türkiye) United Kingdom

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