Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 1, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT04334759). This is a study registration, not published results. Lead sponsor: PrECOG, LLC.. Recruitment status: COMPLETED. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 214 participants (ACTUAL). Conditions: Mesothelioma, Pleural Mesothelioma, Malignant Pleural Mesothelioma. Interventions: DRUG: Durvalumab; DRUG: Standard Chemotherapy; DRUG: Ipilimumab and Nivolumab. Primary outcome measures: Median Overall Survival (OS) , Minimum follow-up is 24 months after randomisation. Median follow-up for survival is of 33 months with range (3 months - 47 months).. Brief summary: Patients with pleural mesothelioma (PM) that cannot be surgically removed will receive standard chemotherapy (cisplatin or carboplatin and pemetrexed) given with durvalumab, a type of immunotherapy, or a treatment chosen by the study doctor, which is either standard chemotherapy or immunotherapy combination (ipilimumab and nivolumab). Durvalumab is an antibody (a type of human protein) that works by blocking a body substance called Programmed Death-Ligand 1 (PD-L1). Blocking PD-L1 helps the body's immune system attack cancer cells. Research has shown that durvalumab can slow tumor growth and shrink tumors in some people with cancer. Previous studies of combining durvalumab and chemotherapy showed that this combination is active in advanced mesothelioma. The purpose of this study is to see whether adding durvalumab to standard chemotherapy will improve overall survival (OS) in patients with PM.