Abstract
TPS7607 Background: CRS-207 is a live-attenuated Listeria monocytogenes (Lm) vaccine expressing the tumor-associated antigen mesothelin which is overexpressed in MPM. CRS-207 was well tolerated and induced Lm- and mesothelin-specific T cell immunity in a phase 1 study in adults with mesothelin-expressing cancers (Le et al., Clin. Cancer Res. 2012). Preclinical and clinical studies suggest that vaccines and chemotherapies work synergistically and augment anti-tumor effectiveness of subsequent chemotherapies. Methods: This phase 1B study is evaluating the safety and induction of mesothelin-specific immune responses by CRS-207 plus chemotherapy with pemetrexed (P) and cisplatin (C) in adults with newly diagnosed, unresectable MPM. Two doses of 1×109colony forming units (CFU) CRSE207 are administered intravenously two weeks apart followed two weeks later by up to six cycles of P (500 mg/m2) and C (75 mg/m2) given every 3 weeks. Two booster vaccinations of CRS-207 are administered three weeks apart 4 weeks after completing PC. Secondary and exploratory endpoints will assess objective tumor response, time to progression, overall survival and immune correlates. This is one of the first trials to assess the synergy between vaccines and chemotherapy in newly diagnosed patients with MPM. Sponsor: Aduro BioTech, Inc. ClinicalTrials.gov ID: NCT01675765. Clinical trial information: NCT01675765.
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