MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

Last updated: April 23, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Lung Cancer

Mesothelioma

Treatment

Volrustomig

Pemetrexed

Carboplatin

Clinical Study ID

NCT06097728
D7988C00001
2023-000067-32
2023-503231-17-00
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Key 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 orwithout 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

Key Exclusion Criteria:

  • As judged by the investigator, any condition that would interfere with evaluation ofthe investigational product or interpretation of participant safety or studyresults.

  • 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 hormonaltherapy for cancer treatment

  • Untreated or progressive CNS metastatic disease

Study Design

Total Participants: 600
Treatment Group(s): 6
Primary Treatment: Volrustomig
Phase: 3
Study Start date:
November 09, 2023
Estimated Completion Date:
March 13, 2028

Study Description

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.

Connect with a study center

  • Research Site

    Chermside, 4032
    Australia

    Active - Recruiting

  • Research Site

    Clayton, 3168
    Australia

    Active - Recruiting

  • Research Site

    Melbourne, 3000
    Australia

    Active - Recruiting

  • Research Site

    Nedlands, 6009
    Australia

    Active - Recruiting

  • Research Site

    Westmead, 2145
    Australia

    Active - Recruiting

  • Research Site

    Anderlecht, 1070
    Belgium

    Active - Recruiting

  • Research Site

    Antwerpen, 2020
    Belgium

    Active - Recruiting

  • Research Site

    Gent, 9000
    Belgium

    Active - Recruiting

  • Research Site

    Hasselt, 3500
    Belgium

    Active - Recruiting

  • Research Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Research Site

    Sint-Niklaas, 9100
    Belgium

    Active - Recruiting

  • Research Site

    Barretos, 14784-400
    Brazil

    Active - Recruiting

  • Research Site

    Fortaleza, 60336-045
    Brazil

    Active - Recruiting

  • Research Site

    Joao Pessoa, 58013-140
    Brazil

    Active - Recruiting

  • Research Site

    Porto Alegre, 91350-200
    Brazil

    Active - Recruiting

  • Research Site

    Rio de Janeiro, 22281-100
    Brazil

    Active - Recruiting

  • Research Site

    Santo Andre, 09060-650
    Brazil

    Active - Recruiting

  • Research Site

    Sao Paulo, 01246-000
    Brazil

    Site Not Available

  • Research Site

    São Paulo, 01246-000
    Brazil

    Active - Recruiting

  • Research Site

    Edmonton, Alberta T6G 1Z2
    Canada

    Active - Recruiting

  • Research Site

    Hamilton, Ontario L8V 1C3
    Canada

    Suspended

  • Research Site

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • Research Site

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Research Site

    Toronto, Ontario M5G 1X6
    Canada

    Active - Recruiting

  • Research Site

    Montreal, Quebec H2X 0C1
    Canada

    Active - Recruiting

  • Research Site

    Quebec, G1V 4G5
    Canada

    Active - Recruiting

  • Research Site

    Beijing, 100210
    China

    Site Not Available

  • Research Site

    Changchun, 130021
    China

    Site Not Available

  • Research Site

    Changsha, 410013
    China

    Active - Recruiting

  • Research Site

    Chengdu, 610042
    China

    Active - Recruiting

  • Research Site

    Chongqing, 400030
    China

    Site Not Available

  • Research Site

    Guangzhou, 510060
    China

    Site Not Available

  • Research Site

    Hangzhou, 310022
    China

    Site Not Available

  • Research Site

    Harbin, 150049
    China

    Site Not Available

  • Research Site

    Kunming, 650118
    China

    Active - Recruiting

  • Research Site

    Lanzhou, 730000
    China

    Active - Recruiting

  • Research Site

    Nanchang, 330006
    China

    Site Not Available

  • Research Site

    Ningbo, 315100
    China

    Active - Recruiting

  • Research Site

    Shanghai, 200032
    China

    Site Not Available

  • Research Site

    Shenyang, 110044
    China

    Site Not Available

  • Research Site

    Taiyuan, 030032
    China

    Site Not Available

  • Research Site

    Tianjin, 300060
    China

    Active - Recruiting

  • Research Site

    Wuhan, 430030
    China

    Active - Recruiting

  • Research Site

    Xi'an, 710061
    China

    Site Not Available

  • Research Site

    Zhengzhou, 450008
    China

    Site Not Available

  • Research Site

    Aarhus N, 8200
    Denmark

    Active - Recruiting

  • Research Site

    Copenhagen, 2100
    Denmark

    Active - Recruiting

  • Research Site

    Brest, 29200
    France

    Active - Recruiting

  • Research Site

    Creteil Cedex, 94010
    France

    Active - Recruiting

  • Research Site

    Le Mans Cedex, 72037
    France

    Active - Recruiting

  • Research Site

    Lille, 59037
    France

    Active - Recruiting

  • Research Site

    Lyon, 69373
    France

    Active - Recruiting

  • Research Site

    Marseille Cedex 20, 13015
    France

    Active - Recruiting

  • Research Site

    Montpellier, 34298
    France

    Active - Recruiting

  • Research Site

    Paris, 75877
    France

    Active - Recruiting

  • Research Site

    Paris Cedex 18, 75877
    France

    Site Not Available

  • Research Site

    Rouen, 76031
    France

    Active - Recruiting

  • Research Site

    Saint Herblain, 44800
    France

    Active - Recruiting

  • Research Site

    Strasbourg, 67091
    France

    Active - Recruiting

  • Research Site

    Toulouse, 31059
    France

    Active - Recruiting

  • Research Site

    Berlin, 13125
    Germany

    Active - Recruiting

  • Research Site

    Bochum, 44791
    Germany

    Active - Recruiting

  • Research Site

    Essen, 45130
    Germany

    Site Not Available

  • Research Site

    Gauting, 82131
    Germany

    Active - Recruiting

  • Research Site

    Georgsmarienhuette, 49124
    Germany

    Active - Recruiting

  • Research Site

    Grosshansdorf, 22927
    Germany

    Site Not Available

  • Research Site

    Hamburg, 21075
    Germany

    Active - Recruiting

  • Research Site

    Heidelberg, 69126
    Germany

    Active - Recruiting

  • Research Site

    Kiel, 24105
    Germany

    Active - Recruiting

  • Research Site

    Köln, 51109
    Germany

    Active - Recruiting

  • Research Site

    Muenster, 48153
    Germany

    Active - Recruiting

  • Research Site

    Münster, 48163
    Germany

    Site Not Available

  • Research Site

    Regensburg, 93049
    Germany

    Site Not Available

  • Research Site

    Alessandria, 15100
    Italy

    Active - Recruiting

  • Research Site

    Bari, 70124
    Italy

    Active - Recruiting

  • Research Site

    Bergamo, 24125
    Italy

    Active - Recruiting

  • Research Site

    Milan, 20141
    Italy

    Active - Recruiting

  • Research Site

    Monza, 20052
    Italy

    Active - Recruiting

  • Research Site

    Orbassano, 10043
    Italy

    Active - Recruiting

  • Research Site

    Padova, 35128
    Italy

    Active - Recruiting

  • Research Site

    Parma, 43100
    Italy

    Active - Recruiting

  • Research Site

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Research Site

    Varese, 21100
    Italy

    Active - Recruiting

  • Research Site

    Amagasaki-shi, 660-8550
    Japan

    Active - Recruiting

  • Research Site

    Hakodate-shi, 040-8611
    Japan

    Site Not Available

  • Research Site

    Hiroshima-shi, 734-8551
    Japan

    Active - Recruiting

  • Research Site

    Kitakyushu-shi, 807-8555
    Japan

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  • Research Site

    Matsuyama-shi, 791-0280
    Japan

    Active - Recruiting

  • Research Site

    Nagoya-shi, 466-8560
    Japan

    Active - Recruiting

  • Research Site

    Nishinomiya-shi, 663-8501
    Japan

    Active - Recruiting

  • Research Site

    Okayama-shi, 702-8055
    Japan

    Active - Recruiting

  • Research Site

    Osakasayama-shi, 589-8511
    Japan

    Active - Recruiting

  • Research Site

    Tokyo, 104-0045
    Japan

    Active - Recruiting

  • Research Site

    Ube-shi, 755-0241
    Japan

    Active - Recruiting

  • Research Site

    Cheongju-si, 28644
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Amsterdam, 1066CX
    Netherlands

    Active - Recruiting

  • Research Site

    Eindhoven, 5623EJ
    Netherlands

    Active - Recruiting

  • Research Site

    Rotterdam, 3015 GD
    Netherlands

    Active - Recruiting

  • Research Site

    Lørenskog, 1478
    Norway

    Active - Recruiting

  • Research Site

    Oslo, 450
    Norway

    Active - Recruiting

  • Research Site

    Bydgoszcz, 85-796
    Poland

    Active - Recruiting

  • Research Site

    Bystra, 43-360
    Poland

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  • Research Site

    Olsztyn, 10-357
    Poland

    Active - Recruiting

  • Research Site

    Poznań, 60-569
    Poland

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  • Research Site

    Rzeszów, 35-241
    Poland

    Site Not Available

  • Research Site

    Warszawa, 02-781
    Poland

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  • Research Site

    Amanzimtoti, 4126
    South Africa

    Active - Recruiting

  • Research Site

    Cape Town, 7570
    South Africa

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  • Research Site

    Johannesburg, 2193
    South Africa

    Active - Recruiting

  • Research Site

    Kimberly, 8301
    South Africa

    Active - Recruiting

  • Research Site

    Kraaifontein, 7570
    South Africa

    Site Not Available

  • Research Site

    Parktown, 2193
    South Africa

    Site Not Available

  • Research Site

    Polokwane, 0700
    South Africa

    Site Not Available

  • Research Site

    Pretoria, 0002
    South Africa

    Active - Recruiting

  • Research Site

    Barakaldo, 48903
    Spain

    Active - Recruiting

  • Research Site

    Barcelona, 8035
    Spain

    Active - Recruiting

  • Research Site

    Madrid, 28041
    Spain

    Active - Recruiting

  • Research Site

    Oviedo, 33011
    Spain

    Active - Recruiting

  • Research Site

    Baden, CH-5405
    Switzerland

    Active - Recruiting

  • Research Site

    Basel, 4031
    Switzerland

    Active - Recruiting

  • Research Site

    Bern, 3010
    Switzerland

    Active - Recruiting

  • Research Site

    Fribourg, 1700
    Switzerland

    Active - Recruiting

  • Research Site

    St. Gallen, 9007
    Switzerland

    Active - Recruiting

  • Research Site

    Kaohsiung, 80756
    Taiwan

    Active - Recruiting

  • Research Site

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • Research Site

    Tainan City, 70403
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Research Site

    Adana, 01060
    Turkey

    Site Not Available

  • Research Site

    Ankara, 06800
    Turkey

    Active - Recruiting

  • Research Site

    Diyarbakir, 21280
    Turkey

    Active - Recruiting

  • Research Site

    Izmir, 35110
    Turkey

    Active - Recruiting

  • Research Site

    Cambridge, CB20QQ
    United Kingdom

    Active - Recruiting

  • Research Site

    Cardiff, Wales, CF5 6NF
    United Kingdom

    Site Not Available

  • Research Site

    Leeds, LS9 7TF
    United Kingdom

    Active - Recruiting

  • Research Site

    Leicester, LE1 5WW
    United Kingdom

    Active - Recruiting

  • Research Site

    London, SE1 9RT
    United Kingdom

    Active - Recruiting

  • Research Site

    Manchester, M23 9LT
    United Kingdom

    Active - Recruiting

  • Research Site

    Middlesborough, TS4 3BW
    United Kingdom

    Active - Recruiting

  • Research Site

    Middlesbrough, TS4 3BW
    United Kingdom

    Site Not Available

  • Research Site

    Newcastle-upon-Tyne, NE2 4HH
    United Kingdom

    Active - Recruiting

  • Research Site

    Portsmouth, PO6 3LY
    United Kingdom

    Active - Recruiting

  • Research Site

    Taunton, TA1 5DA
    United Kingdom

    Active - Recruiting

  • Research Site

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Research Site

    Duarte, California 91010
    United States

    Site Not Available

  • Research Site

    Santa Rosa, California 95403
    United States

    Active - Recruiting

  • Research Site

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Research Site

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Research Site

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Research Site

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Research Site

    Baltimore, Maryland 21231
    United States

    Site Not Available

  • Research Site

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Research Site

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Research Site

    East Brunswick, New Jersey 08816
    United States

    Site Not Available

  • Research Site

    Commack, New York 11725
    United States

    Active - Recruiting

  • Research Site

    Valhalla, New York 10595
    United States

    Site Not Available

  • Research Site

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Research Site

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Research Site

    Independence, Ohio 44131
    United States

    Active - Recruiting

  • Research Site

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Research Site

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Research Site

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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