Full TitlePOLARIS2015-003: Randomized, Double-Blind, Phase 2/3 Study in Subjects with Malignant Pleural Mesothelioma with Low Argininosuccinate Synthetase 1 Expression to Assess ADI-PEG 20 with Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study)
Arginine is a nutrient that makes up proteins. Laboratory studies show that an investigational drug called ADI-PEG 20 can break down arginine, destroying cancer cells. In this study, researchers want to see if adding ADI-PEG 20 to chemotherapy for malignant pleural mesothelioma is more effective against the cancer than chemotherapy alone.
Patients will receive chemotherapy with pemetrexed and cisplatin or carboplatin. They will also be randomly assigned to receive ADI-PEG 20 or a placebo. Pemetrexed and cisplatin/carboplatin are given intravenously (by vein), and ADI-PEG 20 is given by injection.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have malignant pleural mesothelioma that has not yet been treated with chemotherapy or immunotherapy.
- If a patient has had major surgery, at least 4 weeks must pass between the surgery and entry into the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.