MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma
eVOLVE-Meso
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)
3 other identifiers
interventional
863
21 countries
151
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2023
Longer than P75 for phase_3
151 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2023
CompletedFirst Posted
Study publicly available on registry
October 24, 2023
CompletedStudy Start
First participant enrolled
November 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 16, 2028
July 28, 2026
July 1, 2026
5 years
October 4, 2023
July 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS) in experimental arm relative to comparator arm
OS is defined as the time from randomization until the date of death due to any cause.
up to approximately 61 months
Secondary Outcomes (17)
Overall Survival (OS)
up to approximately 61 months
Progression Free Survival (PFS)
up to approximately 61 months
Landmark OS
12, 18, 24, 36 months
Landmark PFS
6, 12, 18, 24 months
Overall Response Rate (ORR)
up to approximately 61 months
- +12 more secondary outcomes
Study Arms (2)
Volrustomig + Carboplatin + pemetrexed
EXPERIMENTALVolrustomig in combination with carboplatin plus pemetrexed
Investigator's choice of standard care
ACTIVE COMPARATORThe 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.
Interventions
MEDI5752: Administered as IV infusion
Alimta: Administered as IV infusion
Paraplatin: Administered as IV infusion
Platinol: Administered as IV infusion
Opdivo: Administered as IV infusion
Yervoy: Administered as IV infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (151)
Research Site
Santa Rosa, California, 95403, United States
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Aurora, Colorado, 80045, United States
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Jacksonville, Florida, 32224, United States
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Atlanta, Georgia, 30322, United States
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Chicago, Illinois, 60637, United States
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Rochester, Minnesota, 55905, United States
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St Louis, Missouri, 63110, United States
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Commack, New York, 11725, United States
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Columbus, Ohio, 43210, United States
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Portland, Oregon, 97213, United States
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Portland, Oregon, 97225, United States
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Philadelphia, Pennsylvania, 19104, United States
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Houston, Texas, 77030, United States
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Fairfax, Virginia, 22031, United States
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Chermside, 4032, Australia
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Clayton, 3168, Australia
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Melbourne, 3000, Australia
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Nedlands, 6009, Australia
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Westmead, 2145, Australia
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Anderlecht, 1070, Belgium
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Antwerp, 2020, Belgium
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Ghent, 9000, Belgium
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Hasselt, 3500, Belgium
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Sint-Niklaas, 9100, Belgium
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Barretos, 14784-400, Brazil
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Fortaleza, 60336-045, Brazil
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Porto Alegre, 91350-200, Brazil
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Rio de Janeiro, 22281-100, Brazil
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Santo André, 09060-650, Brazil
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São Paulo, 01246-000, Brazil
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Edmonton, Alberta, T6G 1Z2, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5G 1X6, Canada
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Montreal, Quebec, H2X 0C1, Canada
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Québec, Quebec, G1V 4G5, Canada
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Beijing, 100142, China
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Beijing, 100210, China
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Changsha, 410013, China
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Chengdu, 610042, China
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Guangzhou, 510100, China
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Hangzhou, 310022, China
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Harbin, 150049, China
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Kunming, 650118, China
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Lanzhou, 730000, China
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Ningbo, 315100, China
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Qingdao, 266003, China
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Shandong, China
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Shanghai, 200032, China
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Shenyang, 110044, China
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Taiyuan, 030000, China
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Taiyuan, 030032, China
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Tianjin, 300050, China
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Tianjin, 300060, China
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Wuhan, 430030, China
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Xi'an, 710061, China
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Zhengzhou, 450008, China
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Zhengzhou, 450052, China
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Aarhus N, 8200, Denmark
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Copenhagen, 2100, Denmark
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Brest, 29200, France
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Créteil, 94010, France
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Le Mans, 72037, France
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Lille, 59037, France
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Lyon, 69373, France
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Marseille, 13015, France
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Montpellier, 34298, France
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Paris, 75877, France
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Rouen, 76031, France
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Saint-Herblain, 44800, France
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Strasbourg, 67091, France
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Toulouse, 31059, France
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Berlin, 13125, Germany
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Berlin, 14109, Germany
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Bochum, 44791, Germany
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Cologne, 51109, Germany
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Essen, 45122, Germany
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Gauting, 82131, Germany
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Georgsmarienhütte, 49124, Germany
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Großhansdorf, 22927, Germany
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Hamburg, 21075, Germany
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Heidelberg, 69126, Germany
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Kiel, 24105, Germany
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Münster, 48153, Germany
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Regensburg, 93049, Germany
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Alessandria, 15100, Italy
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Bari, 70124, Italy
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Bergamo, 24125, Italy
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Milan, 20141, Italy
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Monza, 20052, Italy
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Orbassano, 10043, Italy
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Padova, 35128, Italy
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Parma, 43100, Italy
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Rozzano, 20089, Italy
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Varese, 21100, Italy
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Amagasaki-shi, 660-8550, Japan
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Hakodate-shi, 040-8611, Japan
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Hiroshima, 734-8551, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kitakyushu-shi, 807-8555, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 466-8560, Japan
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Nishinomiya-shi, 663-8501, Japan
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Okayama, 702-8055, Japan
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Osakasayama-shi, 589-8511, Japan
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Tokyo, 104-0045, Japan
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Ube-shi, 755-0241, Japan
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Amsterdam, 1066CX, Netherlands
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Eindhoven, 5623EJ, Netherlands
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Rotterdam, 3015 GD, Netherlands
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Lørenskog, 1478, Norway
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Oslo, 450, Norway
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Bystra, 43-360, Poland
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Olsztyn, 10-357, Poland
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Poznan, 60-569, Poland
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Warsaw, 02-781, Poland
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Cape Town, 7570, South Africa
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eManzimtoti, 4126, South Africa
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Johannesburg, 2013, South Africa
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Johannesburg, 2193, South Africa
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Kimberly, 8301, South Africa
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Pretoria, 0002, South Africa
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Pretoria, 0081, South Africa
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Seoul, 03080, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Barakaldo, 48903, Spain
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Barcelona, 8035, Spain
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Madrid, 28041, Spain
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Oviedo, 33011, Spain
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Baden, CH-5405, Switzerland
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Basel, 4031, Switzerland
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Bern, 3010, Switzerland
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Fribourg, 1700, Switzerland
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Sankt Gallen, 9007, Switzerland
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Kaohsiung City, 80756, Taiwan
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Taichung, 40705, Taiwan
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Taipei, 10002, Taiwan
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Ankara, 06280, Turkey (Türkiye)
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Ankara, 06800, Turkey (Türkiye)
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Diyarbakır, 21280, Turkey (Türkiye)
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Izmir, 35110, Turkey (Türkiye)
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Cambridge, CB20QQ, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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Leicester, LE1 5WW, United Kingdom
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London, NW1 2PG, United Kingdom
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London, SE1 9RT, United Kingdom
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London, SW3 6JJ, United Kingdom
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Manchester, M23 9LT, United Kingdom
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Newcastle upon Tyne, NE2 4HH, United Kingdom
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Portsmouth, PO6 3LY, United Kingdom
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Taunton, TA1 5DA, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marjorie G Zauderer, MD
Memorial Slone Kettering (MSK) Cancer Centre
- PRINCIPAL INVESTIGATOR
Arnaud Scherpereel, MD
Lille University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2023
First Posted
October 24, 2023
Study Start
November 9, 2023
Primary Completion (Estimated)
November 16, 2028
Study Completion (Estimated)
November 16, 2028
Last Updated
July 28, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.