MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

Description

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.

Conditions

Unresectable Pleural Mesothelioma

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Study Overview

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Study Details

Study overview

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.

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)

MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

Condition
Unresectable Pleural Mesothelioma
Intervention / Treatment

-

Contacts and Locations

Phoenix

Research Site, Phoenix, Arizona, United States, 85054

Duarte

Research Site, Duarte, California, United States, 91010

Santa Rosa

Research Site, Santa Rosa, California, United States, 95403

Aurora

Research Site, Aurora, Colorado, United States, 80045

Jacksonville

Research Site, Jacksonville, Florida, United States, 32224

Atlanta

Research Site, Atlanta, Georgia, United States, 30322

Chicago

Research Site, Chicago, Illinois, United States, 60637

Baltimore

Research Site, Baltimore, Maryland, United States, 21231

Rochester

Research Site, Rochester, Minnesota, United States, 55905

Saint Louis

Research Site, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Marjorie G Zauderer, MD, PRINCIPAL_INVESTIGATOR, Memorial Slone Kettering (MSK) Cancer Centre

Arnaud Scherpereel, MD, PRINCIPAL_INVESTIGATOR, Lille University

Study Record Dates

2028-03-13