NCT02004262

Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting

A Phase 2B, Randomized, Controlled, Multicenter, Open-Label Study of the Efficacy and Immune Response of GVAX Pancreas Vaccine (With Cyclophosphamide) and CRS 207 Compared to Chemotherapy or to CRS-207 Alone in Adults With Previously-Treated Metastatic Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Aduro Biotech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to chemotherapy or CRS-207 alone in adults with previously treated metastatic pancreatic adenocarcinoma

Conditions

• 2nd-line, 3rd-line and Greater Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	GVAX Pancreas Vaccine
BIOLOGICAL	CRS-207
DRUG	Chemotherapy	Investigator's choice of one of the following commercially available products: gemcitabine; capecitabine; fluorouracil with or without leucovorin; irinotecan; or erlotinib.
DRUG	cyclophosphamide

Timeline

• Start date: 2014-02-05
• Primary completion: 2016-01-01
• Completion: 2016-08-23
• First posted: 2013-12-09
• Last updated: 2018-06-04
• Results posted: 2018-05-03

Locations

21 sites across 2 countries: United States, Canada