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MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma (eVOLVE-Meso)

Primary Purpose

Unresectable Pleural Mesothelioma

Status

Not yet recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Volrustomig

Pemetrexed

Carboplatin

Cisplatin

Nivolumab

Ipilimumab

About this trial

This is an interventional treatment trial for Unresectable Pleural Mesothelioma focused on measuring Mesothelioma, Pleural Mesothelioma, Unresectable Pleural Mesothelioma, Advanced pleural mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Volrustomig + Carboplatin + pemetrexed

Investigator's choice of standard care

Arm Description

Volrustomig in combination with carboplatin plus pemetrexed

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival (OS)

OS is defined as the time from randomization until the date of death due to any cause.

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.

Landmark OS

Landmarks of OS12, OS18, OS24, and OS36.

Landmark PFS

Landmarks of PFS6, PFS12, PFS18, and PFS24

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.

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.

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.

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.

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.

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.

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.

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.

Immunogenicity of volrustomig

Incidence of Anti-Drug Antibodies against volrustomig.

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).

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.

Maximum plasma concentration of the drug (Cmax)

The concentration of MEDI5752 in serum will be determined (Cmax will be derived).

The time taken to reach the maximum concentration (Tmax)

The concentration of MEDI5752 in serum will be determined (Tmax will be derived).

Full Information

NCT ID

NCT06097728

First Posted

October 4, 2023

Last Updated

October 18, 2023

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT06097728

Brief Title

MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

Acronym

eVOLVE-Meso

Official 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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 30, 2023 (Anticipated)

Primary Completion Date

April 5, 2027 (Anticipated)

Study Completion Date

April 3, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unresectable Pleural Mesothelioma

Keywords

Mesothelioma, Pleural Mesothelioma, Unresectable Pleural Mesothelioma, Advanced pleural mesothelioma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

This is a randomized, open-label, Phase III trial in participants with untreated unresectable pleural mesothelioma. Approximately 600 participants across histology subtypes will be randomized in a 1:1 ratio to receive volrustomig in combination with carboplatin plus pemetrexed or 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.

Masking

Outcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Volrustomig + Carboplatin + pemetrexed

Arm Type

Experimental

Arm Description

Volrustomig in combination with carboplatin plus pemetrexed

Arm Title

Investigator's choice of standard care

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Volrustomig

Other Intervention Name(s)

MEDI5752

Intervention Description

MEDI5752: Administered as IV infusion

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

Alimta

Intervention Description

Alimta: Administered as IV infusion

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

Paraplatin

Intervention Description

Paraplatin: Administered as IV infusion

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

Platinol

Intervention Description

Platinol: Administered as IV infusion

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

Opdivo

Intervention Description

Opdivo: Administered as IV infusion

Intervention Type

Drug

Intervention Name(s)

Ipilimumab

Other Intervention Name(s)

Yervoy

Intervention Description

Yervoy: Administered as IV infusion

Primary Outcome Measure Information:

Title

Overall Survival (OS) in experimental arm relative to comparator arm

Description

OS is defined as the time from randomization until the date of death due to any cause.

Time Frame

up to approximately 52 months

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

OS is defined as the time from randomization until the date of death due to any cause.

Time Frame

up to approximately 52 months

Title

Progression Free Survival (PFS)

Description

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.

Time Frame

up to approximately 52 months

Title

Landmark OS

Description

Landmarks of OS12, OS18, OS24, and OS36.

Time Frame

12, 18, 24, 36 months

Title

Landmark PFS

Description

Landmarks of PFS6, PFS12, PFS18, and PFS24

Time Frame

6, 12, 18, 24 months

Title

Overall Response Rate (ORR)

Description

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.

Time Frame

up to approximately 52 months

Title

Duration of Response (DoR)

Description

Time Frame

up to approximately 52 months

Title

PFS2

Description

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.

Time Frame

up to approximately 52 months

Title

Patient-reported physical functioning

Description

Time Frame

up to approximately 52 months.

Title

Disease-related symptoms using EORTC IL305 (Q1)

Description

Time Frame

Up to approximately 52 months.

Title

Disease-related symptoms using PRO-CTCAE (Q1, 5, 6, 9)

Description

Time Frame

Up to approximately 52 months

Title

Patient-reported role functioning using EORTC QLQ-C30 RF subscale (IL305 Q2 3)

Description

Time Frame

up to approximately 52 months

Title

Patient-reported HRQoL (Health-related Quality of Life) using EORTC QLQ-C30 HRQoL subscale (IL305 Q7-8)

Description

Time Frame

Up to approximately 52 months

Title

Immunogenicity of volrustomig

Description

Incidence of Anti-Drug Antibodies against volrustomig.

Time Frame

up to approximately 52 months

Title

Incidence of Adverse Events (AEs) AEs graded by CTCAE version 5.0

Description

Time Frame

Up to approximately 52 months

Title

Area under the curve (AUC)

Description

Time Frame

Up to approximately 52 months

Title

Maximum plasma concentration of the drug (Cmax)

Description

The concentration of MEDI5752 in serum will be determined (Cmax will be derived).

Time Frame

Up to approximately 52 months

Title

The time taken to reach the maximum concentration (Tmax)

Description

The concentration of MEDI5752 in serum will be determined (Tmax will be derived).

Time Frame

Up to approximately 52 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

AstraZeneca Clinical Study Information Center

Phone

1-877-240-9479

information.center@astrazeneca.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marjorie G Zauderer, MD

Organizational Affiliation

Memorial Slone Kettering (MSK) Cancer Centre, NY

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Arnaud Scherpereel, MD

Organizational Affiliation

Lille University

Official's Role

Principal Investigator

Facility Information:

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Research Site

City

Duarte

State/Province

California

ZIP/Postal Code

91010

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United States

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Research Site

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Santa Rosa

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California

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92805

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United States

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Aurora

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Colorado

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80045

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United States

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Chicago

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Illinois

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60637

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United States

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Commack

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New York

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11725

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United States

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Portland

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Oregon

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97239

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United States

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Philadelphia

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Pennsylvania

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19104

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United States

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Fairfax

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Virginia

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22031

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United States

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Clayton

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3168

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Australia

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Nedlands

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Australia

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Anderlecht

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1070

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Belgium

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Antwerpen

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2020

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Belgium

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Gent

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9000

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Belgium

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Hasselt

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3500

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Belgium

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Leuven

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3000

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Belgium

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Barretos

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14784-400

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Brazil

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Fortaleza

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60336-045

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Brazil

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Joao Pessoa

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58013-140

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Brazil

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Porto Alegre

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91350-200

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Brazil

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Rio de Janeiro

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22281-100

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Brazil

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Santo Andre

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09060-650

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Brazil

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Sao Paulo

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01246-000

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Brazil

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Edmonton

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London

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Ontario

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Canada

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Ottawa

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Ontario

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K1H 8L6

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Canada

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Toronto

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Ontario

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M5G 1X6

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Canada

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Montreal

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Quebec

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H2X 1P1

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Canada

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City

Quebec

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G1V 4G5

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Canada

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City

Beijing

ZIP/Postal Code

100142

Country

China

Facility Name

Research Site

City

Beijing

ZIP/Postal Code

100210

Country

China

Facility Name

Research Site

City

Changsha

ZIP/Postal Code

410013

Country

China

Facility Name

Research Site

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Chengdu

ZIP/Postal Code

610042

Country

China

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Research Site

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Guangzhou

ZIP/Postal Code

510060

Country

China

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Research Site

City

Guangzhou

ZIP/Postal Code

510180

Country

China

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Research Site

City

Hangzhou

ZIP/Postal Code

310022

Country

China

Facility Name

Research Site

City

Harbin

ZIP/Postal Code

150049

Country

China

Facility Name

Research Site

City

Kunming

ZIP/Postal Code

650118

Country

China

Facility Name

Research Site

City

Lanzhou

ZIP/Postal Code

730000

Country

China

Facility Name

Research Site

City

Nanchang

ZIP/Postal Code

330006

Country

China

Facility Name

Research Site

City

Ningbo

ZIP/Postal Code

315100

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China

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Research Site

City

Shanghai

ZIP/Postal Code

200032

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China

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Research Site

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Shenyang

ZIP/Postal Code

110044

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China

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Research Site

City

Taiyuan

ZIP/Postal Code

030032

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China

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Research Site

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Tianjin

ZIP/Postal Code

300052

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China

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Research Site

City

Tianjin

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300060

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China

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Research Site

City

Wuhan

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430030

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China

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Research Site

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Xi'an

ZIP/Postal Code

710061

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China

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Zhengzhou

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450008

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China

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Aarhus N

ZIP/Postal Code

8200

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Denmark

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City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

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Research Site

City

Brest

ZIP/Postal Code

29200

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France

Facility Name

Research Site

City

Creteil Cedex

ZIP/Postal Code

94010

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France

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Research Site

City

Le Mans Cedex

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72037

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France

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Research Site

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Lille

ZIP/Postal Code

59037

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France

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Lyon

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69373

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France

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Marseille Cedex 20

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13015

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France

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Montpellier

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34298

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France

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Rouen

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76031

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France

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Saint Herblain

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44800

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France

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Strasbourg

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67091

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France

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Toulouse

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31059

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France

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Berlin

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13125

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Germany

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Essen

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45130

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Germany

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Gauting

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82131

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Germany

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City

Georgsmarienhuette

ZIP/Postal Code

49124

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Germany

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City

Heidelberg

ZIP/Postal Code

69126

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Germany

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City

Köln

ZIP/Postal Code

51109

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Germany

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City

Münster

ZIP/Postal Code

48163

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Germany

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Alessandria

ZIP/Postal Code

15100

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Italy

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Bari

ZIP/Postal Code

70124

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Italy

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Research Site

City

Bergamo

ZIP/Postal Code

24125

Country

Italy

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Research Site

City

Milan

ZIP/Postal Code

20141

Country

Italy

Facility Name

Research Site

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Monza

ZIP/Postal Code

20052

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Italy

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Research Site

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Orbassano

ZIP/Postal Code

10043

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Italy

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Research Site

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Padova

ZIP/Postal Code

35128

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Italy

Facility Name

Research Site

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Parma

ZIP/Postal Code

43100

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Italy

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Research Site

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Rozzano

ZIP/Postal Code

20089

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Italy

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Research Site

City

Varese

ZIP/Postal Code

21100

Country

Italy

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Research Site

City

Hiroshima-shi

ZIP/Postal Code

734-8551

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Japan

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Research Site

City

Nagoya-shi

ZIP/Postal Code

466-8560

Country

Japan

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Research Site

City

Nishinomiya-shi

ZIP/Postal Code

663-8501

Country

Japan

Facility Name

Research Site

City

Okayama-shi

ZIP/Postal Code

702-8055

Country

Japan

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Research Site

City

Osakasayama-shi

ZIP/Postal Code

589-8511

Country

Japan

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Research Site

City

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

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City

Ube-shi

ZIP/Postal Code

755-0241

Country

Japan

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City

Cheongju-si

ZIP/Postal Code

28644

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Korea, Republic of

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Research Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Research Site

City

Amsterdam

ZIP/Postal Code

1066CX

Country

Netherlands

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Research Site

City

Eindhoven

ZIP/Postal Code

5623EJ

Country

Netherlands

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Research Site

City

Rotterdam

ZIP/Postal Code

3015 GD

Country

Netherlands

Facility Name

Research Site

City

Lørenskog

ZIP/Postal Code

1478

Country

Norway

Facility Name

Research Site

City

Oslo

ZIP/Postal Code

450

Country

Norway

Facility Name

Research Site

City

Bydgoszcz

ZIP/Postal Code

85-796

Country

Poland

Facility Name

Research Site

City

Bystra

ZIP/Postal Code

43-360

Country

Poland

Facility Name

Research Site

City

Olsztyn

ZIP/Postal Code

10-357

Country

Poland

Facility Name

Research Site

City

Poznań

ZIP/Postal Code

60-569

Country

Poland

Facility Name

Research Site

City

Rzeszów

ZIP/Postal Code

35-241

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Research Site

City

Amanzimtoti

ZIP/Postal Code

4126

Country

South Africa

Facility Name

Research Site

City

Johannesburg

ZIP/Postal Code

2013

Country

South Africa

Facility Name

Research Site

City

Kraaifontein

ZIP/Postal Code

7570

Country

South Africa

Facility Name

Research Site

City

Parktown

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Research Site

City

Pretoria

ZIP/Postal Code

0002

Country

South Africa

Facility Name

Research Site

City

Pretoria

ZIP/Postal Code

0081

Country

South Africa

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Research Site

City

Barakaldo

ZIP/Postal Code

48903

Country

Spain

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

8035

Country

Spain

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Research Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Research Site

City

Oviedo

ZIP/Postal Code

33011

Country

Spain

Facility Name

Research Site

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Research Site

City

Basel

ZIP/Postal Code

CH-5405

Country

Switzerland

Facility Name

Research Site

City

Bern

ZIP/Postal Code

CH-3010

Country

Switzerland

Facility Name

Research Site

City

Fribourg

ZIP/Postal Code

1700

Country

Switzerland

Facility Name

Research Site

City

St. Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Research Site

City

Kaohsiung

ZIP/Postal Code

80756

Country

Taiwan

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

Research Site

City

Tainan City

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Research Site

City

Adana

ZIP/Postal Code

01060

Country

Turkey

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06280

Country

Turkey

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06800

Country

Turkey

Facility Name

Research Site

City

Diyarbakir

ZIP/Postal Code

21280

Country

Turkey

Facility Name

Research Site

City

Izmir

ZIP/Postal Code

35110

Country

Turkey

Facility Name

Research Site

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Research Site

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

Research Site

City

Leicester

ZIP/Postal Code

LE1 5WW

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

NW1 2PG

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Research Site

City

Manchester

ZIP/Postal Code

M23 9LT

Country

United Kingdom

Facility Name

Research Site

City

Middlesbrough

ZIP/Postal Code

TS4 3BW

Country

United Kingdom

Facility Name

Research Site

City

Newcastle-upon-Tyne

ZIP/Postal Code

NE2 4HH

Country

United Kingdom

Facility Name

Research Site

City

Portsmouth

ZIP/Postal Code

PO6 3LY

Country

United Kingdom

Facility Name

Research Site

City

Taunton

ZIP/Postal Code

TA1 5DA

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 approved.

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 URL

https://vivli.org/

Learn more about this trial

MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

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MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma (eVOLVE-Meso)

Unresectable Pleural Mesothelioma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial