A Phase 1B Study to Evaluate the Safety and Induction of Immune Response of CRS-207 in Combination With Pemetrexed and Cisplatin as Front-line Therapy in Adults With Malignant Pleural Mesothelioma
Up to 16 subjects will be enrolled in this study. Eligible subjects will receive 2 prime
vaccinations of CRS-207 (1×10^9 colony-forming units [CFU] given intravenously [i.v.] over 2
hours) 2 weeks apart followed 2 weeks later by up to 6 cycles of pemetrexed and cisplatin 21
days apart. Three weeks after completion of chemotherapy, subjects will receive an
additional 2 infusions (boost vaccinations) of CRS-207 3 weeks apart. Subjects will be
followed every 8 weeks until disease progression by immune-related response criteria.
Subjects who continue to meet dosing eligibility may receive additional CRS-207 infusions
(maintenance vaccinations) every 16 weeks.
Study assessments include blood draws for safety and immune response monitoring and CT scans
[with optional fluorodeoxyglucose positron emission tomography (FDG-PET)] or magnetic
resonance imaging (MRI) to monitor disease status. In addition, optional tumor biopsies may
be performed before, during and after treatment.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of subjects reporting adverse events
From first study dose through duration of study (up to 30 weeks or longer)
Raffit Hassan, MD
National Cancer Institute (NCI)
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center||Tampa, Florida 33612|
|University of Chicago Medical Center||Chicago, Illinois 60637|
|University of Pennsylvania Abramson Cancer Center||Philadelphia, Pennsylvania 19104|
|National Cancer Institute||Bethesda, Maryland 20892-1922|