Last updated 8 days ago
MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma
600 patients around the world
Available in Spain, Brazil, United States
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.
AstraZeneca
600Patients around the world
This study is for people with
Mesothelioma
Pleural Mesothelioma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Participant must be ≥ 18 years at the time of screeningHistologically 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 dosingHas measurable disease per modified RECIST1.1Has 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 disordersHistory of another primary malignancy with exceptions.Uncontrolled intercurrent illnessTuberculosis, hepatitis B (HBV) or hepatitis C (HCV), human immunodeficiency virus (HIV) infection that is not well controlledAny concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatmentUntreated or progressive CNS metastatic disease
StudyeVOLVE-Meso
SponsorAstraZeneca
Conditions
Pleural Mesothelioma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06097728
