Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin

Inclusion Criteria

• Histologically proven unresectable MPM of biphasic or sarcomatoid histology
• Naïve to chemotherapy or immunotherapy
• ECOG PS 0-1
• Expected survival of at least 3 months
• Age 18 years or over (there is no upper age limit)
• Measurable disease by modified RECIST criteria for MPM for local pleural disease and RECIST 1.1 criteria for metastatic lesions
• Written (signed and dated) informed consent and must be capable of co-operating with treatment and follow up
• Adequate hematologic, hepatic, and renal function

Exclusion Criteria

• Radiotherapy (except for palliative reasons) in the previous two weeks before study treatment
• History of unstable cardiac disease
• Ongoing toxic manifestations of previous treatments
• Symptomatic brain or spinal cord metastases (patients must be stable for > 1 month post radiotherapy or surgery)
• Major thoracic or abdominal surgery from which the patient has not yet recovered.