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)

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.

Study Overview

• Status: Recruiting
• Conditions: Unresectable Pleural Mesothelioma
• Intervention / Treatment: Drug: Volrustomig; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin; Drug: Nivolumab; Drug: Ipilimumab

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 825
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Australia
  • Chermside, Australia, 4032
    • Active, not recruiting
    • Research Site
  • Clayton, Australia, 3168
    • Active, not recruiting
    • Research Site
  • Melbourne, Australia, 3000
    • Active, not recruiting
    • Research Site
  • Nedlands, Australia, 6009
    • Active, not recruiting
    • Research Site
  • Westmead, Australia, 2145
    • Active, not recruiting
    • Research Site
• Belgium
  • Anderlecht, Belgium, 1070
    • Active, not recruiting
    • Research Site
  • Antwerp, Belgium, 2020
    • Active, not recruiting
    • Research Site
  • Ghent, Belgium, 9000
    • Completed
    • Research Site
  • Hasselt, Belgium, 3500
    • Active, not recruiting
    • Research Site
  • Leuven, Belgium, 3000
    • Withdrawn
    • Research Site
  • Sint-Niklaas, Belgium, 9100
    • Active, not recruiting
    • Research Site
• Brazil
  • Barretos, Brazil, 14784-400
    • Active, not recruiting
    • Research Site
  • Fortaleza, Brazil, 60336-045
    • Active, not recruiting
    • Research Site
  • João Pessoa, Brazil, 58013-140
    • Withdrawn
    • Research Site
  • Porto Alegre, Brazil, 91350-200
    • Active, not recruiting
    • Research Site
  • Rio de Janeiro, Brazil, 22281-100
    • Active, not recruiting
    • Research Site
  • Santo André, Brazil, 09060-650
    • Active, not recruiting
    • Research Site
  • São Paulo, Brazil, 01246-000
    • Active, not recruiting
    • Research Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Active, not recruiting
      • Research Site
  • Ontario
    • Hamilton, Ontario, Canada, L8V 1C3
      • Withdrawn
      • Research Site
    • London, Ontario, Canada, N6A 5W9
      • Withdrawn
      • Research Site
    • Ottawa, Ontario, Canada, K1H 8L6
      • Active, not recruiting
      • Research Site
    • Toronto, Ontario, Canada, M5G 1X6
      • Active, not recruiting
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H2X 0C1
      • Active, not recruiting
      • Research Site
    • Québec, Quebec, Canada, G1V 4G5
      • Active, not recruiting
      • Research Site
• China
  • Beijing, China, 100142
    • Active, not recruiting
    • Research Site
  • Beijing, China, 100210
    • Active, not recruiting
    • Research Site
  • Changchun, China, 130021
    • Withdrawn
    • Research Site
  • Changsha, China, 410013
    • Active, not recruiting
    • Research Site
  • Chengdu, China, 610042
    • Active, not recruiting
    • Research Site
  • Chongqing, China, 400030
    • Withdrawn
    • Research Site
  • Guangzhou, China, 510100
    • Active, not recruiting
    • Research Site
  • Hangzhou, China, 310022
    • Active, not recruiting
    • Research Site
  • Harbin, China, 150049
    • Active, not recruiting
    • Research Site
  • Kunming, China, 650118
    • Active, not recruiting
    • Research Site
  • Lanzhou, China, 730000
    • Active, not recruiting
    • Research Site
  • Nanchang, China, 330006
    • Withdrawn
    • Research Site
  • Ningbo, China, 315100
    • Active, not recruiting
    • Research Site
  • Qingdao, China, 266003
    • Active, not recruiting
    • Research Site
  • Shandong, China
    • Active, not recruiting
    • Research Site
  • Shanghai, China, 200032
    • Active, not recruiting
    • Research Site
  • Shenyang, China, 110044
    • Active, not recruiting
    • Research Site
  • Taiyuan, China, 030000
    • Active, not recruiting
    • Research Site
  • Taiyuan, China, 030032
    • Active, not recruiting
    • Research Site
  • Tianjin, China, 300060
    • Active, not recruiting
    • Research Site
  • Tianjin, China, 300050
    • Active, not recruiting
    • Research Site
  • Wuhan, China, 430030
    • Active, not recruiting
    • Research Site
  • Xi'an, China, 710061
    • Completed
    • Research Site
  • Zhengzhou, China, 450008
    • Active, not recruiting
    • Research Site
  • Zhengzhou, China, 450052
    • Active, not recruiting
    • Research Site
• Denmark
  • Aarhus N, Denmark, 8200
    • Active, not recruiting
    • Research Site
  • Copenhagen, Denmark, 2100
    • Active, not recruiting
    • Research Site
• France
  • Brest, France, 29200
    • Completed
    • Research Site
  • Créteil, France, 94010
    • Active, not recruiting
    • Research Site
  • Le Mans, France, 72037
    • Active, not recruiting
    • Research Site
  • Lille, France, 59037
    • Active, not recruiting
    • Research Site
  • Lyon, France, 69373
    • Active, not recruiting
    • Research Site
  • Marseille, France, 13015
    • Active, not recruiting
    • Research Site
  • Montpellier, France, 34298
    • Active, not recruiting
    • Research Site
  • Paris, France, 75877
    • Active, not recruiting
    • Research Site
  • Rouen, France, 76031
    • Active, not recruiting
    • Research Site
  • Saint-Herblain, France, 44800
    • Active, not recruiting
    • Research Site
  • Strasbourg, France, 67091
    • Active, not recruiting
    • Research Site
  • Toulouse, France, 31059
    • Active, not recruiting
    • Research Site
• Germany
  • Berlin, Germany, 13125
    • Recruiting
    • Research Site
  • Berlin, Germany, 14109
    • Recruiting
    • Research Site
  • Bochum, Germany, 44791
    • Recruiting
    • Research Site
  • Cologne, Germany, 51109
    • Recruiting
    • Research Site
  • Essen, Germany, 45122
    • Recruiting
    • Research Site
  • Essen, Germany, 45130
    • Withdrawn
    • Research Site
  • Gauting, Germany, 82131
    • Recruiting
    • Research Site
  • Georgsmarienhütte, Germany, 49124
    • Recruiting
    • Research Site
  • Großhansdorf, Germany, 22927
    • Recruiting
    • Research Site
  • Hamburg, Germany, 21075
    • Recruiting
    • Research Site
  • Heidelberg, Germany, 69126
    • Recruiting
    • Research Site
  • Kiel, Germany, 24105
    • Recruiting
    • Research Site
  • Münster, Germany, 48153
    • Recruiting
    • Research Site
  • Regensburg, Germany, 93049
    • Recruiting
    • Research Site
• Italy
  • Alessandria, Italy, 15100
    • Active, not recruiting
    • Research Site
  • Bari, Italy, 70124
    • Active, not recruiting
    • Research Site
  • Bergamo, Italy, 24125
    • Active, not recruiting
    • Research Site
  • Milan, Italy, 20141
    • Active, not recruiting
    • Research Site
  • Monza, Italy, 20052
    • Active, not recruiting
    • Research Site
  • Orbassano, Italy, 10043
    • Active, not recruiting
    • Research Site
  • Padova, Italy, 35128
    • Active, not recruiting
    • Research Site
  • Parma, Italy, 43100
    • Active, not recruiting
    • Research Site
  • Rozzano, Italy, 20089
    • Active, not recruiting
    • Research Site
  • Varese, Italy, 21100
    • Active, not recruiting
    • Research Site
• Japan
  • Amagasaki-shi, Japan, 660-8550
    • Active, not recruiting
    • Research Site
  • Hakodate-shi, Japan, 040-8611
    • Active, not recruiting
    • Research Site
  • Hiroshima, Japan, 734-8551
    • Active, not recruiting
    • Research Site
  • Kitaadachi-gun, Japan, 362-0806
    • Active, not recruiting
    • Research Site
  • Kitakyushu-shi, Japan, 807-8555
    • Active, not recruiting
    • Research Site
  • Matsuyama, Japan, 791-0280
    • Active, not recruiting
    • Research Site
  • Nagoya, Japan, 466-8560
    • Active, not recruiting
    • Research Site
  • Nishinomiya-shi, Japan, 663-8501
    • Active, not recruiting
    • Research Site
  • Okayama, Japan, 702-8055
    • Active, not recruiting
    • Research Site
  • Osakasayama-shi, Japan, 589-8511
    • Active, not recruiting
    • Research Site
  • Tokyo, Japan, 104-0045
    • Active, not recruiting
    • Research Site
  • Ube-shi, Japan, 755-0241
    • Active, not recruiting
    • Research Site
• Netherlands
  • Amsterdam, Netherlands, 1066CX
    • Active, not recruiting
    • Research Site
  • Eindhoven, Netherlands, 5623EJ
    • Active, not recruiting
    • Research Site
  • Rotterdam, Netherlands, 3015 GD
    • Active, not recruiting
    • Research Site
• Norway
  • Lørenskog, Norway, 1478
    • Completed
    • Research Site
  • Oslo, Norway, 450
    • Active, not recruiting
    • Research Site
• Poland
  • Bydgoszcz, Poland, 85-796
    • Withdrawn
    • Research Site
  • Bystra, Poland, 43-360
    • Active, not recruiting
    • Research Site
  • Olsztyn, Poland, 10-357
    • Active, not recruiting
    • Research Site
  • Poznan, Poland, 60-569
    • Active, not recruiting
    • Research Site
  • Rzeszów, Poland, 35-241
    • Withdrawn
    • Research Site
  • Warsaw, Poland, 02-781
    • Active, not recruiting
    • Research Site
• South Africa
  • Cape Town, South Africa, 7570
    • Active, not recruiting
    • Research Site
  • Johannesburg, South Africa, 2013
    • Active, not recruiting
    • Research Site
  • Johannesburg, South Africa, 2193
    • Active, not recruiting
    • Research Site
  • Kimberly, South Africa, 8301
    • Active, not recruiting
    • Research Site
  • Polokwane, South Africa, 0700
    • Withdrawn
    • Research Site
  • Pretoria, South Africa, 0002
    • Active, not recruiting
    • Research Site
  • Pretoria, South Africa, 0081
    • Active, not recruiting
    • Research Site
  • eManzimtoti, South Africa, 4126
    • Active, not recruiting
    • Research Site
• South Korea
  • Cheongju-si, South Korea, 28644
    • Withdrawn
    • Research Site
  • Seoul, South Korea, 06351
    • Recruiting
    • Research Site
  • Seoul, South Korea, 06591
    • Recruiting
    • Research Site
  • Seoul, South Korea, 03080
    • Active, not recruiting
    • Research Site
  • Ulsan, South Korea, 44033
    • Withdrawn
    • Research Site
• Spain
  • Barakaldo, Spain, 48903
    • Active, not recruiting
    • Research Site
  • Barcelona, Spain, 8035
    • Active, not recruiting
    • Research Site
  • Madrid, Spain, 28041
    • Active, not recruiting
    • Research Site
  • Oviedo, Spain, 33011
    • Active, not recruiting
    • Research Site
• Switzerland
  • Baden, Switzerland, CH-5405
    • Active, not recruiting
    • Research Site
  • Basel, Switzerland, 4031
    • Active, not recruiting
    • Research Site
  • Bern, Switzerland, 3010
    • Active, not recruiting
    • Research Site
  • Fribourg, Switzerland, 1700
    • Active, not recruiting
    • Research Site
  • Sankt Gallen, Switzerland, 9007
    • Active, not recruiting
    • Research Site
• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Active, not recruiting
    • Research Site
  • Taichung, Taiwan, 40705
    • Active, not recruiting
    • Research Site
  • Tainan, Taiwan, 70403
    • Withdrawn
    • Research Site
  • Taipei, Taiwan, 10002
    • Active, not recruiting
    • Research Site
  • Taoyuan District, Taiwan, 333
    • Withdrawn
    • Research Site
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01060
    • Withdrawn
    • Research Site
  • Ankara, Turkey (Türkiye), 06800
    • Active, not recruiting
    • Research Site
  • Ankara, Turkey (Türkiye), 06280
    • Active, not recruiting
    • Research Site
  • Diyarbakır, Turkey (Türkiye), 21280
    • Active, not recruiting
    • Research Site
  • Izmir, Turkey (Türkiye), 35110
    • Active, not recruiting
    • Research Site
• United Kingdom
  • Cambridge, United Kingdom, CB20QQ
    • Active, not recruiting
    • Research Site
  • Cardiff, Wales, United Kingdom, CF5 6NF
    • Withdrawn
    • Research Site
  • Leeds, United Kingdom, LS9 7TF
    • Active, not recruiting
    • Research Site
  • Leicester, United Kingdom, LE1 5WW
    • Active, not recruiting
    • Research Site
  • London, United Kingdom, NW1 2PG
    • Active, not recruiting
    • Research Site
  • London, United Kingdom, SE1 9RT
    • Active, not recruiting
    • Research Site
  • London, United Kingdom, SW3 6JJ
    • Active, not recruiting
    • Research Site
  • Manchester, United Kingdom, M23 9LT
    • Active, not recruiting
    • Research Site
  • Newcastle upon Tyne, United Kingdom, NE2 4HH
    • Active, not recruiting
    • Research Site
  • Portsmouth, United Kingdom, PO6 3LY
    • Active, not recruiting
    • Research Site
  • Taunton, United Kingdom, TA1 5DA
    • Active, not recruiting
    • Research Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Withdrawn
      • Research Site
  • California
    • Duarte, California, United States, 91010
      • Withdrawn
      • Research Site
    • Santa Rosa, California, United States, 95403
      • Recruiting
      • Research Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Research Site
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Recruiting
      • Research Site
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Research Site
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Research Site
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Withdrawn
      • Research Site
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Research Site
    • Valhalla, New York, United States, 10595
      • Recruiting
      • Research Site
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Withdrawn
      • Research Site
    • Cleveland, Ohio, United States, 44124
      • Withdrawn
      • Research Site
    • Cleveland, Ohio, United States, 44111
      • Withdrawn
      • Research Site
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Research Site
    • Independence, Ohio, United States, 44131
      • Withdrawn
      • Research Site
  • Oregon
    • Portland, Oregon, United States, 97213
      • Recruiting
      • Research Site
    • Portland, Oregon, United States, 97239
      • Withdrawn
      • Research Site
    • Portland, Oregon, United States, 97225
      • Recruiting
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Research Site
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Research Site
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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

Key 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Volrustomig + Carboplatin + pemetrexed; Volrustomig in combination with carboplatin plus pemetrexed	Drug: Volrustomig; MEDI5752: Administered as IV infusion; Other Names: MEDI5752; Drug: Pemetrexed; Alimta: Administered as IV infusion; Other Names: Alimta; Drug: Carboplatin; Paraplatin: Administered as IV infusion; Other Names: Paraplatin
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.	Drug: Pemetrexed; Alimta: Administered as IV infusion; Other Names: Alimta; Drug: Carboplatin; Paraplatin: Administered as IV infusion; Other Names: Paraplatin; Drug: Cisplatin; Platinol: Administered as IV infusion; Other Names: Platinol; Drug: Nivolumab; Opdivo: Administered as IV infusion; Other Names: Opdivo; Drug: Ipilimumab; Yervoy: Administered as IV infusion; Other Names: Yervoy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Landmark OS	Landmarks of OS12, OS18, OS24, and OS36.	12, 18, 24, 36 months
Landmark PFS	Landmarks of PFS6, PFS12, PFS18, and PFS24	6, 12, 18, 24 months
Overall Survival (OS)	OS is defined as the time from randomization until the date of death due to any cause.	up to approximately 61 months
Progression Free Survival (PFS)	PFS is defined as the time from randomization until progression per mRECIST 1.1 and/or RECIST 1.1 as assessed by the investigator at local site, or death due to any cause.	up to approximately 61 months
Overall Response Rate (ORR)	Proportion of participants who have a confirmed Complete Response or confirmed Partial Response, as determined by the investigator at local site per mRECIST 1.1 and/or RECIST 1.1.	up to approximately 61 months
Duration of Response (DoR)	DoR defined as the time from the date of first documented response until date of documented progression per mRECIST 1.1 and/or RECIST 1.1 as assessed by the investigator at local site or death due to any cause.	up to approximately 61 months
PFS2	PFS2 defined as the time from randomization to the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death.	up to approximately 61 months
Patient-reported physical functioning	TTD in physical functioning as measured by PROMIS (Patient Reported Outcomes Measurement Information System) Physical Function Short Form 8c. There are 8 questions each from a scale of 1 (unable to do) to a scale of 5 (With a little difficulty). The higher the scores the better the patient-reported physical functioning is.	up to approximately 61 months.
Disease-related symptoms using EORTC IL305 (Q1)	Change from baseline in disease-related symptoms as measured by individual symptom items from the EORTC (European Organisation For Research And Treatment Of Cancer) IL305 (Item Library 305) (Q1). It is scored from a 1 (not at all) to a 4 (very much). The higher the score the higher the disease-related symptoms.	Up to approximately 61 months.
Disease-related symptoms using PRO-CTCAE (Q1, 5, 6, 9)	Change from baseline in disease-related symptoms as measured by individual symptom items from the PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) (Q1, 5, 6, 9). PRO-CTCAE responses are scored from 0 to 4 (or 0/1 for absent/present). The higher the score the higher the disease-related symptoms.	Up to approximately 61 months
Patient-reported role functioning using EORTC QLQ-C30 RF subscale (IL305 Q2 3)	Change from baseline in functioning will be assessed by the following measure: Role functioning: EORTC (European Organisation For Research And Treatment Of Cancer) QLQ (Quality of Life Questionnaire) -C30 RF (Role Functioning) subscale (IL305 Q2 3) (Item Library 305). The questions are from a scale of 1 (not at all) to 4 (very much). The lower the score the higher the patient-reported role functioning is.	up to approximately 61 months
Patient-reported HRQoL (Health-related Quality of Life) using EORTC QLQ-C30 HRQoL subscale (IL305 Q7-8)	Change from baseline in functioning will be assessed by the following measure: HRQoL: EORTC (European Organisation For Research And Treatment Of Cancer) QLQ (Quality of Life Questionnaire) -C30 HRQoL subscale (IL305 Q7-8) (Item Library 305). The questions are from a scale of 1 (very poor) to 7 (excellent). The higher the score the higher the HRQoL.	Up to approximately 61 months
Immunogenicity of volrustomig	Incidence of Anti-Drug Antibodies against volrustomig.	up to approximately 61 months
Incidence of Adverse Events (AEs) AEs graded by CTCAE version 5.0	Incidence of Adverse Events (AEs) AEs graded by CTCAE (Common Terminology Criteria for Adverse Events) version 5.0. Grade refers to the severity of the AE. The CTCAE displays grade 1 (mild) through 5 (death related to AE). Grade 2 (moderate), Grade 3 (Severe) and Grade 4 (Life-threatening consequences).	Up to approximately 61 months
Area under the curve (AUC)	The concentration of MEDI5752 in serum will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.	Up to approximately 61 months
Maximum plasma concentration of the drug (Cmax)	The concentration of MEDI5752 in serum will be determined (Cmax will be derived).	Up to approximately 61 months
The time taken to reach the maximum concentration (Tmax)	The concentration of MEDI5752 in serum will be determined (Tmax will be derived).	Up to approximately 61 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Arnaud Scherpereel, MD, Lille University; Principal Investigator: Marjorie G Zauderer, MD, Memorial Slone Kettering (MSK) Cancer Centre

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2023
• Primary Completion (Estimated): November 19, 2027
• Study Completion (Estimated): November 16, 2028

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Mesothelioma; Pleural Mesothelioma; Unresectable Pleural Mesothelioma; Advanced pleural mesothelioma
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenoma; Neoplasms, Mesothelial; Pleural Neoplasms; Mesothelioma, Malignant; Mesothelioma; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Platinum Compounds; Nivolumab; Pemetrexed; Ipilimumab; Carboplatin; Cisplatin
• Other Study ID Numbers: D7988C00001; 2023-000067-32 (EudraCT Number); 2023-503231-17-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No