NCT03161379

GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer

A Phase II Clinical Trial of GVAX Pancreas Vaccine (With Cyclophosphamide) in Combination With Nivolumab and Stereotactic Body Radiation Therapy (SBRT) Followed by Definitive Resection for Patients With Borderline Resectable Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and clinical activity of FOLFIRINOX along with a whole cell vaccine with immune modulating doses of cyclophosphamide and nivolumab combined with Stereotactic Body Radiation Therapy (SBRT) in patients with pancreatic cancer.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Cyclophosphamide 200 mg/m2 will be administered one day prior to vaccination (day 0). First dose will be given within 4 to 6 weeks after chemotherapy. 3 weeks after the first dose of immunotherapy the second dose will be given.
DRUG	Nivolumab	Nivolumab (240 mg) will be administered one day prior to vaccination. First dose will be given within 4 to 6 weeks after chemotherapy. 3 weeks after the first dose of immunotherapy the second dose will be given.
DRUG	GVAX Pancreas Vaccine	Vaccine will be administered one day after cyclophosphamide and nivolumab. 3 weeks after the first dose of immunotherapy the second dose will be given.
RADIATION	Stereotactic Body Radiation (SBRT)	SBRT (6.6 Gy over 5 days) will be started during the second dose of immunotherapy (3 weeks after the first dose of immunotherapy).

Timeline

• Start date: 2018-02-02
• Primary completion: 2024-02-20
• Completion: 2024-02-28
• First posted: 2017-05-19
• Last updated: 2025-02-03
• Results posted: 2025-02-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study