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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)

Considering a clinical trial is an important option when deciding on your treatment course of action. If interested in the study detailed below, please follow up with your care team to learn if it may be right for you. Note that the enrollment status of the study may change.

About This Trial

    Conditions
    • Unresectable Pleural Mesothelioma

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.

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.

Eligibility Criteria

Ages Eligible for Study:
18 Years and older

Genders Eligible for Study:
All

Accepts Healthy Volunteers:
No

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