At a glance
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Randomized, Double-Blind, Phase 2/3 Study in Subjects With Malignant Pleural Mesotheliomato Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study)
In Brief
A Phase 3 clinical trial evaluating ADI-PEG 20 plus Pem Platinum and Placebo plus Pem Platinum for Mesothelioma. Completed, enrolled 249 participants across 45 sites in 5 countries.
Detailed Summary
This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma. Malignant pleural mesothelioma have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the malignant pleural mesothelioma cells will starve and die.
Study Details
Timeline
Interventions
Investigational Drug in combination approved standard of care treatment for this indication
Placebo in combination approved standard of care treatment for this indication