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NCT Number: NCT06097728

MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Unresectable Pleural Mesothelioma Adenoma Lung Diseases Lung Neoplasms Mesothelioma Mesothelioma, Malignant Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Chermside, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Volrustomig

Drug

MEDI5752: Administered as IV infusion

Other names: MEDI5752

Pemetrexed

Drug

Alimta: Administered as IV infusion

Other names: Alimta

carboplatin

Drug

Paraplatin: Administered as IV infusion

Other names: Paraplatin

Cisplatin

Drug

Platinol: Administered as IV infusion

Other names: Platinol

Nivolumab

Drug

Opdivo: Administered as IV infusion

Other names: Opdivo

Ipilimumab

Drug

Yervoy: Administered as IV infusion

Other names: Yervoy

Primary outcomes

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

    Time frame: up to approximately 61 months

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

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: up to approximately 61 months

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

  2. Progression Free Survival (PFS)

    Time frame: up to approximately 61 months

    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.

  3. Landmark OS

    Time frame: 12, 18, 24, 36 months

    Landmarks of OS12, OS18, OS24, and OS36.

  4. Landmark PFS

    Time frame: 6, 12, 18, 24 months

    Landmarks of PFS6, PFS12, PFS18, and PFS24

  5. Overall Response Rate (ORR)

    Time frame: up to approximately 61 months

    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.

  6. Duration of Response (DoR)

    Time frame: up to approximately 61 months

    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.

  7. PFS2

    Time frame: up to approximately 61 months

    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.

  8. Patient-reported physical functioning

    Time frame: up to approximately 61 months.

    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.

  9. Disease-related symptoms using EORTC IL305 (Q1)

    Time frame: Up to approximately 61 months.

    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.

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

    Time frame: Up to approximately 61 months

    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.

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

    Time frame: up to approximately 61 months

    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.

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

    Time frame: Up to approximately 61 months

    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.

  13. Immunogenicity of volrustomig

    Time frame: up to approximately 61 months

    Incidence of Anti-Drug Antibodies against volrustomig.

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

    Time frame: Up to approximately 61 months

    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).

  15. Area under the curve (AUC)

    Time frame: Up to approximately 61 months

    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.

  16. Maximum plasma concentration of the drug (Cmax)

    Time frame: Up to approximately 61 months

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

  17. The time taken to reach the maximum concentration (Tmax)

    Time frame: Up to approximately 61 months

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Acronym: eVOLVE-Meso

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Oct 24, 2023
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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