Study With CY, Pembrolizumab, GVAX Pancreas Vaccine, and SBRT in Patients With Locally Advanced Pancreatic Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

July 18, 2016

Primary Completion Date

June 1, 2022

Study Completion Date

June 1, 2022

Conditions
Pancreatic Cancer
Interventions
DRUG

Cyclophosphamide

200 mg/m2 is to be administered as a 30 minute IV infusion one day prior to GVAX Pancreas Vaccine every 21 days for a total of 8 doses. In the extended treatment phase, eligible patients may receive 200 mg/m2 as a 30 minute IV infusion one day prior to GVAX Pancreas Vaccine every 6 months for an additional 4 doses.

DRUG

GVAX Pancreatic Cancer Vaccine

2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells is to be administered one day after CY and pembrolizumab for a total of 8 doses. In the extended treatment phase, eligible patients may receive 2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells administered one day after CY every 6 months for an additional 4 doses.

DRUG

Pembrolizumab

200 mg will be administered as a 30 minute IV infusion one day prior to the GVAX pancreas vaccine every 21 days for a total of 8 doses. In the extended treatment phase, eligible patients may receive 200 mg as a 30 minute IV infusion every 21 days for an additional 9 doses.

RADIATION

SBRT

Patients will receive SBRT (6.6 Gy for 5 days) with the second dose of combined immunotherapy (CY/Pembrolizumab/GVAX Pancreas Vaccine).

Trial Locations (1)

21231

The Sidney Kimmel Comprehensive Cancer at Johns Hopkins, Baltimore

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT02648282 - Study With CY, Pembrolizumab, GVAX Pancreas Vaccine, and SBRT in Patients With Locally Advanced Pancreatic Cancer | Biotech Hunter | Biotech Hunter