Safety and Efficacy of the Therapeutic Vaccine GI-4000 in Combination With Gemcitabine Versus Placebo for the Treatment of Non-metastatic, Post-resection Pancreas Cancer

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The GI-4000 therapeutic vaccine or placebo will be injected under the skin of post-resection, non-metastatic pancreas cancer patients. Patients will be monitored for recurrence as well as safety, and immune responses related to the injections.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlobeImmune
• Treatments: Gemcitabine; Pancreatin; Pancrelipase

Criteria

(A few general items required)

Inclusion Criteria:

• Patients with non-metastatic pancreas cancer post-resection that have a product-related ras mutation

• >18 years of age

• Negative skin test for hypersensitivity to Saccharomyces cerevisiae

Exclusion Criteria:

• Metastatic pancreas cancer patients post-resection

• Patients with no product-related ras mutation.