GVAX Pancreas Vaccine (With CY) In Combination With Nivolumab And SBRT For Patients With Borderline Resectable Pancreatic Cancer

Study Overview

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

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.

N/A

Pancreatic Cancer

DRUG: Cyclophosphamide
DRUG: Nivolumab
DRUG: GVAX Pancreas Vaccine
RADIATION: Stereotactic Body Radiation (SBRT)

J1756
IRB00130075 (OTHER Identifier) (OTHER: JHM IRB)

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 2017-05-18	Results First Submitted 2025-01-02	Last Update Submitted that met QC Criteria 2025-01-28
First Submitted that Met QC Criteria 2017-05-18	Results First Submitted that Met QC Criteria 2025-01-28	Last Update Posted (ACTUAL) 2025-02-03
First Posted (ACTUAL) 2017-05-19	Results First Posted 2025-02-03	Last Verified 2025-01

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: CY, Nivolumab, GVAX, and SBRT CY, Nivolumab, GVAX, and SBRT	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).

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: CY, Nivolumab, GVAX, and SBRT

CY, Nivolumab, GVAX, and SBRT

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).

Primary Outcome Measures	Measure Description	Time Frame
CD8+ T Cell Density in Tumor Tissue	Mean CD8+ T cell density [log(cells per mm^2)], found in resected surgical tissue by Immunohistochemistry (IHC).	evaluated at time of surgery, approximately 2 months from first dose of study drug

Secondary Outcome Measures	Measure Description	Time Frame
Pathologic Complete Response (pCR) Rate at Surgical Resection	Number of patients with a pathologic complete response (pCR) rate at surgical resection. A pCR is defined as no viable residual tumor remaining at the time of evaluation.	Assessed at time of surgical resection, approximately 2 months after first dose of study drug

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:

Have histologically proven pancreatic cancer that is borderline resectable
No more than 1 month/cycle (28 days) of systemic therapy for pancreatic cancer
Age >18 years old.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
Woman of child bearing potential must have a negative pregnancy test.
Must use an acceptable form of birth control while on study.
Must be candidate for Stereotactic Body Radiation Therapy (SBRT)
Ability to understand and the willingness to sign a written informed consent document.

Had major surgery within the last 28 days
Had an investigational drug or device within the past 28 days
Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc)
Completed more than 1 month/cycle (28 days) of chemotherapy for pancreas cancer
Patient on an immunosuppressive systemic treatment, such as steroids, in the past 2 years.
Other cancer diagnosis requiring treatment within two years
History of allergic reactions related to the drugs (Nivolumab, Cyclophosphamide, GM-hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of the GVAX vaccine) in this study.
Patients receiving growth factors within the last 14 days.
Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, psychological, immune or other medical conditions.
Pregnant or breastfeeding.
Have known history of infection with HIV, hepatitis B, or hepatitis C.
Unwilling or unable to follow the study schedule for any reason.
Presence of tissue or organ allograft, regardless of need for immunosuppression (including corneal allograft)
Squamous pancreatic cancer or adenosquamous pancreatic cancer with malignant squamous cells >30%

Collaborators and Investigators

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

Bristol-Myers Squibb

Investigators

PRINCIPAL_INVESTIGATOR: Daniel Laheru, 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

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Resources

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Clinical Trial Record