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.
Interventional
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)
Yes
Raffit Hassan, MD
Principal Investigator
National Cancer Institute (NCI)
United States: Food and Drug Administration
ADU-CL-02
NCT01675765
August 2012
June 2014
Name | Location |
---|---|
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 |