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

MORAb-009-003 Amatuximab

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.

2008-12-31

2011-06-30

2014-01-10

Completed

Early phase I

89

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 89, 'type': 'ACTUAL'}}

2022-09-22