RECRUITING

MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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)

Quick Facts

Study Start:2023-11-09
Study Completion:2028-03-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06097728

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant must be ≥ 18 years at the time of screening
  2. * Histologically proven diagnosis of pleural mesothelioma with known histology (epithelioid vs. non-epithelioid)
  3. * Advanced unresectable disease that cannot be treated with curative surgery (with or without chemotherapy)
  4. * 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
  5. * Has measurable disease per modified RECIST1.1
  6. * Has adequate bone marrow reserve and organ function at baseline
  1. * As judged by the investigator, any condition that would interfere with evaluation of the investigational product or interpretation of participant safety or study results.
  2. * Active or prior documented autoimmune or inflammatory disorders
  3. * History of another primary malignancy with exceptions.
  4. * Uncontrolled intercurrent illness
  5. * Tuberculosis, hepatitis B (HBV) or hepatitis C (HCV), human immunodeficiency virus (HIV) infection that is not well controlled
  6. * Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment
  7. * Untreated or progressive CNS metastatic disease

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Principal Investigator

Marjorie G Zauderer, MD
PRINCIPAL_INVESTIGATOR
Memorial Slone Kettering (MSK) Cancer Centre
Arnaud Scherpereel, MD
PRINCIPAL_INVESTIGATOR
Lille University

Study Locations (Sites)

Research Site
Phoenix, Arizona, 85054
United States
Research Site
Duarte, California, 91010
United States
Research Site
Santa Rosa, California, 95403
United States
Research Site
Aurora, Colorado, 80045
United States
Research Site
Jacksonville, Florida, 32224
United States
Research Site
Atlanta, Georgia, 30322
United States
Research Site
Chicago, Illinois, 60637
United States
Research Site
Baltimore, Maryland, 21231
United States
Research Site
Rochester, Minnesota, 55905
United States
Research Site
Saint Louis, Missouri, 63110
United States
Research Site
East Brunswick, New Jersey, 08816
United States
Research Site
Commack, New York, 11725
United States
Research Site
Valhalla, New York, 10595
United States
Research Site
Cleveland, Ohio, 44111
United States
Research Site
Cleveland, Ohio, 44124
United States
Research Site
Cleveland, Ohio, 44195
United States
Research Site
Columbus, Ohio, 43210
United States
Research Site
Independence, Ohio, 44131
United States
Research Site
Portland, Oregon, 97213
United States
Research Site
Portland, Oregon, 97239
United States
Research Site
Philadelphia, Pennsylvania, 19104
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: AstraZeneca

  • Marjorie G Zauderer, MD, PRINCIPAL_INVESTIGATOR, Memorial Slone Kettering (MSK) Cancer Centre
  • Arnaud Scherpereel, MD, PRINCIPAL_INVESTIGATOR, Lille University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-09
Study Completion Date2028-03-13

Study Record Updates

Study Start Date2023-11-09
Study Completion Date2028-03-13

Terms related to this study

Keywords Provided by Researchers

  • Mesothelioma
  • Pleural Mesothelioma
  • Unresectable Pleural Mesothelioma
  • Advanced pleural mesothelioma

Additional Relevant MeSH Terms

  • Unresectable Pleural Mesothelioma