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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
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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)
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Secondary ID [1]
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0
2023-000067-32
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Secondary ID [2]
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D7988C00001
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Universal Trial Number (UTN)
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Trial acronym
eVOLVE-Meso
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Unresectable Pleural Mesothelioma
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS) in experimental arm relative to comparator arm
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Assessment method [1]
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OS is defined as the time from randomization until the date of death due to any cause.
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Timepoint [1]
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up to approximately 52 months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from randomization until the date of death due to any cause.
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Timepoint [1]
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up to approximately 52 months
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Secondary outcome [2]
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Progression Free Survival (PFS)
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Assessment method [2]
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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.
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Timepoint [2]
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up to approximately 52 months
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Secondary outcome [3]
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Landmark OS
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Assessment method [3]
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Landmarks of OS12, OS18, OS24, and OS36.
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Timepoint [3]
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12, 18, 24, 36 months
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Secondary outcome [4]
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Landmark PFS
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Assessment method [4]
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Landmarks of PFS6, PFS12, PFS18, and PFS24
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Timepoint [4]
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6, 12, 18, 24 months
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Secondary outcome [5]
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Overall Response Rate (ORR)
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Assessment method [5]
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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.
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Timepoint [5]
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up to approximately 52 months
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Secondary outcome [6]
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Duration of Response (DoR)
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Assessment method [6]
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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.
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Timepoint [6]
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0
up to approximately 52 months
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Secondary outcome [7]
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PFS2
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Assessment method [7]
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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.
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Timepoint [7]
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0
up to approximately 52 months
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Secondary outcome [8]
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Patient-reported physical functioning
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Assessment method [8]
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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.
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Timepoint [8]
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0
up to approximately 52 months.
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Secondary outcome [9]
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Disease-related symptoms using EORTC IL305 (Q1)
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Assessment method [9]
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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.
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Timepoint [9]
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Up to approximately 52 months.
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Secondary outcome [10]
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Disease-related symptoms using PRO-CTCAE (Q1, 5, 6, 9)
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Assessment method [10]
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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.
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Timepoint [10]
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Up to approximately 52 months
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Secondary outcome [11]
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Patient-reported role functioning using EORTC QLQ-C30 RF subscale (IL305 Q2 3)
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Assessment method [11]
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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.
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Timepoint [11]
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up to approximately 52 months
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Secondary outcome [12]
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Patient-reported HRQoL (Health-related Quality of Life) using EORTC QLQ-C30 HRQoL subscale (IL305 Q7-8)
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Assessment method [12]
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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.
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Timepoint [12]
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Up to approximately 52 months
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Secondary outcome [13]
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Immunogenicity of volrustomig
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Assessment method [13]
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Incidence of Anti-Drug Antibodies against volrustomig.
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Timepoint [13]
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up to approximately 52 months
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Secondary outcome [14]
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Incidence of Adverse Events (AEs) AEs graded by CTCAE version 5.0
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Assessment method [14]
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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).
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Timepoint [14]
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Up to approximately 52 months
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Secondary outcome [15]
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Area under the curve (AUC)
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Assessment method [15]
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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.
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Timepoint [15]
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Up to approximately 52 months
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Secondary outcome [16]
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Maximum plasma concentration of the drug (Cmax)
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Assessment method [16]
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The concentration of MEDI5752 in serum will be determined (Cmax will be derived).
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Timepoint [16]
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Up to approximately 52 months
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Secondary outcome [17]
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The time taken to reach the maximum concentration (Tmax)
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Assessment method [17]
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The concentration of MEDI5752 in serum will be determined (Tmax will be derived).
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Timepoint [17]
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Up to approximately 52 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/11/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
13/03/2028
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Actual
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Sample size
Target
600
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Chermside
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Recruitment hospital [2]
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Research Site - Clayton
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Recruitment hospital [3]
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Research Site - Melbourne
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Recruitment hospital [4]
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Research Site - Nedlands
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Recruitment hospital [5]
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Research Site - Westmead
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Recruitment postcode(s) [1]
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4032 - Chermside
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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3000 - Melbourne
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment postcode(s) [5]
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2145 - Westmead
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Florida
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Illinois
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Gent
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Hasselt
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Belgium
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Leuven
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Harbin
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Kunming
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Lanzhou
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Wuhan
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Xi'an
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Zhengzhou
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Denmark
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Aarhus N
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Essen
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Gauting
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Heidelberg
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Kiel
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Köln
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Muenster
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Alessandria
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Italy
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Bari
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Italy
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Bergamo
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Italy
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Milan
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Italy
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Monza
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Italy
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Italy
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Padova
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Parma
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Italy
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Rozzano
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Italy
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Varese
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Japan
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Amagasaki-shi
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Japan
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Hiroshima-shi
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Kitakyushu-shi
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Japan
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Matsuyama-shi
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Okayama-shi
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Osakasayama-shi
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Tokyo
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Japan
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Ube-shi
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Korea, Republic of
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Cheongju-si
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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Netherlands
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Eindhoven
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Netherlands
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Rotterdam
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Norway
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Lørenskog
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Norway
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Oslo
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Poland
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Bydgoszcz
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Poland
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Bystra
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Poland
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Olsztyn
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Poland
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Poznan
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Poland
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Rzeszów
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Poland
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Warszawa
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South Africa
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Amanzimtoti
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South Africa
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Johannesburg
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South Africa
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Kraaifontein
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South Africa
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Parktown
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South Africa
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Pretoria
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Spain
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State/province [112]
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Barakaldo
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Oviedo
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Switzerland
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Baden
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
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Fribourg
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Switzerland
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St. Gallen
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan City
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Taiwan
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Taipei
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Diyarbakir
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Turkey
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Izmir
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United Kingdom
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Cambridge
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United Kingdom
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Cardiff, Wales
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United Kingdom
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Leeds
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Middlesborough
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United Kingdom
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Newcastle-upon-Tyne
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United Kingdom
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Portsmouth
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United Kingdom
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State/province [138]
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Taunton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT06097728
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Marjorie G Zauderer, MD
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Address
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Memorial Slone Kettering (MSK) Cancer Centre
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Fax
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Email
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Contact person for public queries
Name
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AstraZeneca Clinical Study Information Center
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Address
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Country
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Phone
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1-877-240-9479
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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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.
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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.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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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