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

GlobeImmune

Status and phase: Completed; Phase 2

Conditions: Pancreas Cancer

Treatments: Biological: GI-4000; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00300950

GI-4000-02

Details and patient eligibility

About

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.

Enrollment: 176 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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176 participants in 2 patient groups

1

Active Comparator group

Description:

Gencitabine

Treatment:

Biological: GI-4000

2

Experimental group

Description:

Gemcitabine with GI-4000

Treatment:

Drug: Gemcitabine