An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma

An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma

This research is being done to find out if pemetrexed and cisplatin work better when given together with an experimental drug called MORAb-009 in patients with malignant pleural mesothelioma.

Primary Inclusion Criteria:

• Confirmed diagnosis of malignant pleural mesothelioma (MPM) with the following characteristics: unresectable disease (or otherwise not a candidate for curative surgery); epithelial type or biphasic (mixed) type with low sarcomatous content.
• Measurable disease at Screening by computed tomography (CT)(or magnetic resonance imaging [MRI]).
• KPS of greater than or equal to 70% at Screening.
• Life expectancy of at least 3 months

Primary Exclusion Criteria:

• Sarcomatous type of mesothelioma
• Prior systemic therapy or radiotherapy for MPM; local radiotherapy for symptom control (ie, non-curative intent) is permitted.
• Confirmed presence of CNS tumor involvement.
• Evidence of other active malignancy requiring treatment.