drugset / Trial / NCT04334759

DuRvalumab With chEmotherapy as First Line treAtment in Advanced Pleural Mesothelioma

NCT04334759

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-02-18
Primary completion
2025-06-20
Completion
2025-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Comparator Ipilimumab Monoclonal antibody 1 mg/kg
Comparator Nivolumab Monoclonal antibody 3 mg/kg
Comparator Nivolumab Monoclonal antibody 360 mg
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous