Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06097728




Registration number
NCT06097728
Ethics application status
Date submitted
4/10/2023
Date registered
24/10/2023
Date last updated
21/11/2024

Titles & IDs
Public title
MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma
Scientific title
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)
Secondary ID [1] 0 0
2023-503231-17-00
Secondary ID [2] 0 0
D7988C00001
Universal Trial Number (UTN)
Trial acronym
eVOLVE-Meso
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unresectable Pleural Mesothelioma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Volrustomig
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Nivolumab
Treatment: Drugs - Ipilimumab

Experimental: Volrustomig + Carboplatin + pemetrexed - Volrustomig in combination with carboplatin plus pemetrexed

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.


Treatment: Drugs: Volrustomig
MEDI5752: Administered as IV infusion

Treatment: Drugs: Pemetrexed
Alimta: Administered as IV infusion

Treatment: Drugs: Carboplatin
Paraplatin: Administered as IV infusion

Treatment: Drugs: Cisplatin
Platinol: Administered as IV infusion

Treatment: Drugs: Nivolumab
Opdivo: Administered as IV infusion

Treatment: Drugs: Ipilimumab
Yervoy: Administered as IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) in experimental arm relative to comparator arm
Timepoint [1] 0 0
up to approximately 52 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
up to approximately 52 months
Secondary outcome [2] 0 0
Progression Free Survival (PFS)
Timepoint [2] 0 0
up to approximately 52 months
Secondary outcome [3] 0 0
Landmark OS
Timepoint [3] 0 0
12, 18, 24, 36 months
Secondary outcome [4] 0 0
Landmark PFS
Timepoint [4] 0 0
6, 12, 18, 24 months
Secondary outcome [5] 0 0
Overall Response Rate (ORR)
Timepoint [5] 0 0
up to approximately 52 months
Secondary outcome [6] 0 0
Duration of Response (DoR)
Timepoint [6] 0 0
up to approximately 52 months
Secondary outcome [7] 0 0
PFS2
Timepoint [7] 0 0
up to approximately 52 months
Secondary outcome [8] 0 0
Patient-reported physical functioning
Timepoint [8] 0 0
up to approximately 52 months.
Secondary outcome [9] 0 0
Disease-related symptoms using EORTC IL305 (Q1)
Timepoint [9] 0 0
Up to approximately 52 months.
Secondary outcome [10] 0 0
Disease-related symptoms using PRO-CTCAE (Q1, 5, 6, 9)
Timepoint [10] 0 0
Up to approximately 52 months
Secondary outcome [11] 0 0
Patient-reported role functioning using EORTC QLQ-C30 RF subscale (IL305 Q2 3)
Timepoint [11] 0 0
up to approximately 52 months
Secondary outcome [12] 0 0
Patient-reported HRQoL (Health-related Quality of Life) using EORTC QLQ-C30 HRQoL subscale (IL305 Q7-8)
Timepoint [12] 0 0
Up to approximately 52 months
Secondary outcome [13] 0 0
Immunogenicity of volrustomig
Timepoint [13] 0 0
up to approximately 52 months
Secondary outcome [14] 0 0
Incidence of Adverse Events (AEs) AEs graded by CTCAE version 5.0
Timepoint [14] 0 0
Up to approximately 52 months
Secondary outcome [15] 0 0
Area under the curve (AUC)
Timepoint [15] 0 0
Up to approximately 52 months
Secondary outcome [16] 0 0
Maximum plasma concentration of the drug (Cmax)
Timepoint [16] 0 0
Up to approximately 52 months
Secondary outcome [17] 0 0
The time taken to reach the maximum concentration (Tmax)
Timepoint [17] 0 0
Up to approximately 52 months

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/03/2028
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Chermside
Recruitment hospital [2] 0 0
Research Site - Clayton
Recruitment hospital [3] 0 0
Research Site - Melbourne
Recruitment hospital [4] 0 0
Research Site - Nedlands
Recruitment hospital [5] 0 0
Research Site - Westmead
Recruitment postcode(s) [1] 0 0
4032 - Chermside
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
Belgium
State/province [17] 0 0
Anderlecht
Country [18] 0 0
Belgium
State/province [18] 0 0
Antwerpen
Country [19] 0 0
Belgium
State/province [19] 0 0
Gent
Country [20] 0 0
Belgium
State/province [20] 0 0
Hasselt
Country [21] 0 0
Belgium
State/province [21] 0 0
Leuven
Country [22] 0 0
Belgium
State/province [22] 0 0
Sint-Niklaas
Country [23] 0 0
Brazil
State/province [23] 0 0
Barretos
Country [24] 0 0
Brazil
State/province [24] 0 0
Fortaleza
Country [25] 0 0
Brazil
State/province [25] 0 0
Joao Pessoa
Country [26] 0 0
Brazil
State/province [26] 0 0
Porto Alegre
Country [27] 0 0
Brazil
State/province [27] 0 0
Rio de Janeiro
Country [28] 0 0
Brazil
State/province [28] 0 0
Santo Andre
Country [29] 0 0
Brazil
State/province [29] 0 0
São Paulo
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
Canada
State/province [32] 0 0
Quebec
Country [33] 0 0
China
State/province [33] 0 0
Beijing
Country [34] 0 0
China
State/province [34] 0 0
Changsha
Country [35] 0 0
China
State/province [35] 0 0
Chengdu
Country [36] 0 0
China
State/province [36] 0 0
Guangzhou
Country [37] 0 0
China
State/province [37] 0 0
Hangzhou
Country [38] 0 0
China
State/province [38] 0 0
Harbin
Country [39] 0 0
China
State/province [39] 0 0
Kunming
Country [40] 0 0
China
State/province [40] 0 0
Lanzhou
Country [41] 0 0
China
State/province [41] 0 0
Nanchang
Country [42] 0 0
China
State/province [42] 0 0
Ningbo
Country [43] 0 0
China
State/province [43] 0 0
Shanghai
Country [44] 0 0
China
State/province [44] 0 0
Shenyang
Country [45] 0 0
China
State/province [45] 0 0
Taiyuan
Country [46] 0 0
China
State/province [46] 0 0
Tianjin
Country [47] 0 0
China
State/province [47] 0 0
Wuhan
Country [48] 0 0
China
State/province [48] 0 0
Xi'an
Country [49] 0 0
China
State/province [49] 0 0
Zhengzhou
Country [50] 0 0
Denmark
State/province [50] 0 0
Aarhus N
Country [51] 0 0
Denmark
State/province [51] 0 0
Copenhagen
Country [52] 0 0
France
State/province [52] 0 0
Brest
Country [53] 0 0
France
State/province [53] 0 0
Creteil Cedex
Country [54] 0 0
France
State/province [54] 0 0
Le Mans Cedex
Country [55] 0 0
France
State/province [55] 0 0
Lille
Country [56] 0 0
France
State/province [56] 0 0
Lyon
Country [57] 0 0
France
State/province [57] 0 0
Marseille Cedex 20
Country [58] 0 0
France
State/province [58] 0 0
Montpellier
Country [59] 0 0
France
State/province [59] 0 0
Paris
Country [60] 0 0
France
State/province [60] 0 0
Rouen
Country [61] 0 0
France
State/province [61] 0 0
Saint Herblain
Country [62] 0 0
France
State/province [62] 0 0
Strasbourg
Country [63] 0 0
France
State/province [63] 0 0
Toulouse
Country [64] 0 0
Germany
State/province [64] 0 0
Berlin
Country [65] 0 0
Germany
State/province [65] 0 0
Bochum
Country [66] 0 0
Germany
State/province [66] 0 0
Essen
Country [67] 0 0
Germany
State/province [67] 0 0
Gauting
Country [68] 0 0
Germany
State/province [68] 0 0
Georgsmarienhuette
Country [69] 0 0
Germany
State/province [69] 0 0
Hamburg
Country [70] 0 0
Germany
State/province [70] 0 0
Heidelberg
Country [71] 0 0
Germany
State/province [71] 0 0
Kiel
Country [72] 0 0
Germany
State/province [72] 0 0
Köln
Country [73] 0 0
Germany
State/province [73] 0 0
Muenster
Country [74] 0 0
Italy
State/province [74] 0 0
Alessandria
Country [75] 0 0
Italy
State/province [75] 0 0
Bari
Country [76] 0 0
Italy
State/province [76] 0 0
Bergamo
Country [77] 0 0
Italy
State/province [77] 0 0
Milan
Country [78] 0 0
Italy
State/province [78] 0 0
Monza
Country [79] 0 0
Italy
State/province [79] 0 0
Orbassano
Country [80] 0 0
Italy
State/province [80] 0 0
Padova
Country [81] 0 0
Italy
State/province [81] 0 0
Parma
Country [82] 0 0
Italy
State/province [82] 0 0
Rozzano
Country [83] 0 0
Italy
State/province [83] 0 0
Varese
Country [84] 0 0
Japan
State/province [84] 0 0
Amagasaki-shi
Country [85] 0 0
Japan
State/province [85] 0 0
Hiroshima-shi
Country [86] 0 0
Japan
State/province [86] 0 0
Kitakyushu-shi
Country [87] 0 0
Japan
State/province [87] 0 0
Matsuyama-shi
Country [88] 0 0
Japan
State/province [88] 0 0
Nagoya-shi
Country [89] 0 0
Japan
State/province [89] 0 0
Nishinomiya-shi
Country [90] 0 0
Japan
State/province [90] 0 0
Okayama-shi
Country [91] 0 0
Japan
State/province [91] 0 0
Osakasayama-shi
Country [92] 0 0
Japan
State/province [92] 0 0
Tokyo
Country [93] 0 0
Japan
State/province [93] 0 0
Ube-shi
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Cheongju-si
Country [95] 0 0
Korea, Republic of
State/province [95] 0 0
Seoul
Country [96] 0 0
Netherlands
State/province [96] 0 0
Amsterdam
Country [97] 0 0
Netherlands
State/province [97] 0 0
Eindhoven
Country [98] 0 0
Netherlands
State/province [98] 0 0
Rotterdam
Country [99] 0 0
Norway
State/province [99] 0 0
Lørenskog
Country [100] 0 0
Norway
State/province [100] 0 0
Oslo
Country [101] 0 0
Poland
State/province [101] 0 0
Bydgoszcz
Country [102] 0 0
Poland
State/province [102] 0 0
Bystra
Country [103] 0 0
Poland
State/province [103] 0 0
Olsztyn
Country [104] 0 0
Poland
State/province [104] 0 0
Poznan
Country [105] 0 0
Poland
State/province [105] 0 0
Rzeszów
Country [106] 0 0
Poland
State/province [106] 0 0
Warszawa
Country [107] 0 0
South Africa
State/province [107] 0 0
Amanzimtoti
Country [108] 0 0
South Africa
State/province [108] 0 0
Johannesburg
Country [109] 0 0
South Africa
State/province [109] 0 0
Kraaifontein
Country [110] 0 0
South Africa
State/province [110] 0 0
Polokwane
Country [111] 0 0
South Africa
State/province [111] 0 0
Pretoria
Country [112] 0 0
Spain
State/province [112] 0 0
Barakaldo
Country [113] 0 0
Spain
State/province [113] 0 0
Barcelona
Country [114] 0 0
Spain
State/province [114] 0 0
Madrid
Country [115] 0 0
Spain
State/province [115] 0 0
Oviedo
Country [116] 0 0
Switzerland
State/province [116] 0 0
Baden
Country [117] 0 0
Switzerland
State/province [117] 0 0
Basel
Country [118] 0 0
Switzerland
State/province [118] 0 0
Bern
Country [119] 0 0
Switzerland
State/province [119] 0 0
Fribourg
Country [120] 0 0
Switzerland
State/province [120] 0 0
St. Gallen
Country [121] 0 0
Taiwan
State/province [121] 0 0
Kaohsiung
Country [122] 0 0
Taiwan
State/province [122] 0 0
Taichung
Country [123] 0 0
Taiwan
State/province [123] 0 0
Tainan City
Country [124] 0 0
Taiwan
State/province [124] 0 0
Taipei
Country [125] 0 0
Turkey
State/province [125] 0 0
Adana
Country [126] 0 0
Turkey
State/province [126] 0 0
Ankara
Country [127] 0 0
Turkey
State/province [127] 0 0
Diyarbakir
Country [128] 0 0
Turkey
State/province [128] 0 0
Izmir
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Cambridge
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Cardiff, Wales
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Leeds
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Leicester
Country [133] 0 0
United Kingdom
State/province [133] 0 0
London
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Manchester
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Middlesborough
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Newcastle-upon-Tyne
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Portsmouth
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Taunton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT06097728
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marjorie G Zauderer, MD
Address 0 0
Memorial Slone Kettering (MSK) Cancer Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06097728