Study of Pembrolizumab With REOLYSIN® and Chemotherapy in Patients With Advanced Pancreatic Adenocarcinoma

PHASE1CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

March 31, 2018

Study Completion Date

August 31, 2018

Conditions
Pancreatic Adenocarcinoma
Interventions
BIOLOGICAL

REOLYSIN®

4.5x10E10 TCID50 1 hour intravenous infusion, administered on Day 1 and 2 of a 21-day cycle

DRUG

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

DRUG

Gemcitabine

1000 mg/m2 intravenous infusion over 30 minutes on Day 1 of a 21-day cycle or

DRUG

Irinotecan

125 mg/m2 intravenous infusion over 90 minutes on Day 1 of a 21-day cyle or

DRUG

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

DRUG

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

DRUG

Pembrolizumab

Pembrolizumab, 2 mg/kg intravenous infusion 30 minutes on Day 8 of a 21-day cycle

Trial Locations (1)

78229

Cancer Therapy & Research Center at UTHSCSA, San Antonio

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Oncolytics Biotech

INDUSTRY