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

January 28, 2025 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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%

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other Names:
  • CY
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.
Other Names:
  • OPDIVO
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.
Other Names:
  • PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD8+ T Cell Density in Tumor Tissue
Time Frame: evaluated at time of surgery, approximately 2 months from first dose of study drug
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

Outcome Measure
Measure Description
Time Frame
Pathologic Complete Response (pCR) Rate at Surgical Resection
Time Frame: Assessed at time of surgical resection, approximately 2 months after first dose of study drug
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

Collaborators and Investigators

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

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Daniel Laheru, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Principal Investigator: Arsen Osipov, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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 Major Dates

Study Start (Actual)

February 2, 2018

Primary Completion (Actual)

February 20, 2024

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

May 18, 2017

First Submitted That Met QC Criteria

May 18, 2017

First Posted (Actual)

May 19, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J1756
  • IRB00130075 (Other Identifier: JHM IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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