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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

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
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Portsmouth
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Taunton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06097728