J13108 - A Phase 2, Multicenter Study of FOLFIRINOX Followed by Ipilimumab in Combination with Allogeneic GM-CSF Transfected Pancreatic Tumor Vaccine in the Treatment of Metastatic Pancreatic Cancer
This research is being done to compare the effectiveness of ipilimumab and a pancreatic tumor vaccine in continuation of chemotherapy in people with stable metastatic pancreatic cancer after upfront FOLFIRINOX (5-fluorouracil/ irinotecan/oxaliplatin) treatment. We also want to understand the safetyand side effects of ipilimumab when given in combination with a pancreatic tumor vaccine. We want to see if this combination can help the bodyâ??s immune system recognize and attack its own pancreatic cancer cells.
Histologically proven adenocarcinoma of the pancreasMust be stable metastatic pancreatic cancer after receiving 8-12 cycles of FOLFIRINOXECOG 0-1Adequate organ and marrow functionNo evidence of brain metastasesCannot have pancreas cancer of the ampulla, distal bile duct or duodenumNo prior history of chemotherapy except for FOLFIRINOXNo radiographic ascitesNo prior treatment with Ipilumumab, anti-PD 1 antibody, CD137 agonist or other immune activating therapyNo non-oncology live vaccinations within the past 28 daysNo history of HIV, Hepatitis B or C
Patients are randomized into either getting Ipilimumab and the pancreas vaccine every 3 weeks for 4 doses (and then will enter maintenance dosing phase which is given every 8 weeks) or patients will continue on their FOLFIRINOX or other acceptable combination of chemotherapy.
12/18/2014 04:03 AM