11
Participants
Start Date
December 31, 2015
Primary Completion Date
March 31, 2018
Study Completion Date
August 31, 2018
REOLYSIN®
4.5x10E10 TCID50 1 hour intravenous infusion, administered on Day 1 and 2 of a 21-day cycle
Chemotherapy
Patients may be treated with one of three chemotherapy backbone regimens. The decision on the chemotherapy backbone is based on physician preference.This includes either: a) Gemcitabine or b) Irinotecan or c)Leucovorin followed by 5-fluorouracil
Gemcitabine
1000 mg/m2 intravenous infusion over 30 minutes on Day 1 of a 21-day cycle or
Irinotecan
125 mg/m2 intravenous infusion over 90 minutes on Day 1 of a 21-day cyle or
Leucovorin
Leucovorin (LV) followed by 5-fluorouracil (5FU). LV 200 mg/m2 intravenous infusion over 2 hours on Day 1, 5FU 200 mg/m2 intravenous infusion bolus over 5-10 minutes on Day 1, followed by 5FU 1200 mg/m2 continuous intravenous infusion over 22 hours on Day 1 of a 21-day cycle
5-fluorouracil
Leucovorin (LV) followed by 5-fluorouracil (5FU). LV 200 mg/m2 intravenous infusion over 2 hours on Day 1, 5FU 200 mg/m2 intravenous infusion bolus over 5-10 minutes on Day 1, followed by 5FU 1200 mg/m2 continuous intravenous infusion over 22 hours on Day 1 of a 21-day cycle
Pembrolizumab
Pembrolizumab, 2 mg/kg intravenous infusion 30 minutes on Day 8 of a 21-day cycle
Cancer Therapy & Research Center at UTHSCSA, San Antonio
Lead Sponsor
Oncolytics Biotech
INDUSTRY