NCT02243371

GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab

A Randomized Phase 2 Study of the Safety, Efficacy, and Immune Response of GVAX Pancreas Vaccine (With Cyclophosphamide) and CRS-207 With or Without Nivolumab in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to compare the overall survival (OS) of subjects with previously treated metastatic pancreatic cancer treated with cyclophosphamide (CY)/nivolumab/GVAX pancreas vaccine followed by nivolumab/CRS-207 (Arm A) to subjects treated with CY/GVAX pancreas vaccine followed by CRS-207 (Arm B).

Conditions

• Previously Treated Metastatic Adenocarcinoma of the Pancreas

Interventions

Type	Name	Description
BIOLOGICAL	CRS-207	1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6
BIOLOGICAL	CRS-207	1 × 10\^9 CFU administered IV on Day 1 of Cycles 3-6
DRUG	nivolumab	3 mg/kg administered IV on Day 1 of Cycles 1-6
BIOLOGICAL	GVAX	5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
DRUG	CY	200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2

Timeline

• Start date: 2015-01-02
• Primary completion: 2017-07-21
• Completion: 2017-07-21
• First posted: 2014-09-17
• Last updated: 2021-04-06
• Results posted: 2019-10-08

Locations

5 sites across 1 country: United States