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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)
The purpose of the research study is to assess the effectiveness, safety and tolerability (good and/or bad effects) of the study drug ADI-PEG 20 when given in combination with pemetrexed and cisplatin to participants with mesothelioma. Investigators will also see how many people have tumor shrinkage, how long people live and how long they live without their tumors getting worse with both treatments.
The primary objective of this study is: Determine efficacy as determined by response rate (RR), measured by modified RECIST and RECIST 1.1 criteria (phase 2 portion), and PFS (phase 3 portion). The secondary objectives of this study are: Assessment of safety and tolerability of ADI-PEG 20 in combination with pemetrexed and cisplatin. Determine duration of response. Assess overall survival (OS). Determine the pharmacodynamics of ADI-PEG 20 in combination with pemetrexed and cisplatin. Determine the immunogenicity of ADI-PEG 20 in combination with pemetrexed and cisplatin.
ADI-PEG 20 (); Alimta (Pemetrexed); Paraplatin (carboplatin); Pemetrexed (); Placebo (); carboplatin (); cisplatin ()