Study With CY, Pembrolizumab, GVAX Pancreas Vaccine, And SBRT In Patients With Locally Advanced Pancreatic Cancer

Study Overview

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

This study will be looking at whether combining cyclophosphamide, pembrolizumab (an antibody that blocks negative signals to T cells), GVAX (pancreatic cancer vaccine), and SBRT (focused radiation) is effective (anti-tumor activity) and safe in patients with locally advanced pancreatic cancer.

N/A

Pancreatic Cancer

DRUG: Cyclophosphamide
DRUG: GVAX Pancreatic Cancer Vaccine
DRUG: Pembrolizumab
RADIATION: SBRT

J15237
IRB00083132 (OTHER Identifier) (OTHER: JHMIRB)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-01-05	Results First Submitted 2023-01-31	Last Update Submitted that met QC Criteria 2024-08-30
First Submitted that Met QC Criteria 2016-01-06	Results First Submitted that Met QC Criteria 2023-02-01	Last Update Posted (ACTUAL) 2024-09-05
First Posted (ACTUAL) 2016-01-07	Results First Posted 2023-02-28	Last Verified 2024-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT	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 GV 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 (Pa 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 a RADIATION: SBRT Patients will receive SBRT (6.6 Gy for 5 days) with the second dose of combined immunotherapy (CY/Pembrolizumab/GVAX Pancreas Vaccine).

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT

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 GV

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 (Pa

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 a

RADIATION: SBRT

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

Primary Outcome Measures	Measure Description	Time Frame
Distant Metastasis Free Survival (DMFS)	DMFS is defined as the duration of time from start of treatment to identification of distant metastases on imaging or death, whichever occurs first. Estimation based on the Kaplan-Meier curve.	62 months

Secondary Outcome Measures	Measure Description	Time Frame
Number of Participants Experiencing a Grade 3 or Above Treatment Related Toxicities	When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject.	41 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Merck Sharp & Dohme LLC

Investigators

PRINCIPAL_INVESTIGATOR: Valerie Lee, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

Patients

Caregivers

Clinical Trial Record