Purpose: This clinical trial will evaluate the safety and immune response of the sequential administration cancer vaccine CRS-207 followed by standard of care chemotherapy (pemetrexed and cisplatin). CRS-207 is a weakened (attenuated) form of Listeria monocytogenes that has been genetically-modified to reduce its capacity to cause disease, while maintaining its ability to stimulate potent immune responses. CRS-207 has been engineered to elicit an immune response against the tumor-associated antigen mesothelin, which has been shown to be present at higher levels on certain tumor cells (such asmesothelioma) than on normal cells. Pemetrexed and cisplatin are the standard chemotherapy regimen to treat malignant pleural mesothelioma. This trial will evaluate whether giving CRS-207 cancer vaccine with chemotherapy will induce anti-tumor immune responses and/or objective tumor response.
- Experimental Arm: Vaccine plus chemotherapy
- Weeks 1 and 3: CRS-207 (1 × 10^9 CFU)
- Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): Pemetrexed (500 mg/m2) and cisplatin (75 mg/m2)
- Weeks 23 and 26: CRS-207
- Maintenance Vaccinations: CRS-207 every 16 weeks (starting at Week 30) until disease progression
- Assigned Interventions: Biological: Vaccine plus chemotherapy
- CRS-207
- Listeria
- Pemetrexed
- Cisplatin
- ALIMTA
- Platinol