Clinical Trials /

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

NCT03161379

Description:

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.

Related Conditions:
  • Pancreatic Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: J1756
  • SECONDARY ID: IRB00130075
  • NCT ID: NCT03161379

Conditions

  • Pancreatic Cancer

Interventions

DrugSynonymsArms
CyclophosphamideCYCY, Nivolumab, GVAX, and SBRT
NivolumabOPDIVOCY, Nivolumab, GVAX, and SBRT
GVAX Pancreas VaccinePANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccineCY, Nivolumab, GVAX, and SBRT

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
CY, Nivolumab, GVAX, and SBRTExperimentalCY, Nivolumab, GVAX, and SBRT
  • Cyclophosphamide
  • Nivolumab
  • GVAX Pancreas Vaccine

Eligibility Criteria

        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%
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pathologic complete response (pCR) rate at surgical resection.
Time Frame:4 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of subjects who receive an R0 surgical resection.
Time Frame:4 years
Safety Issue:
Description:
Measure:Objective response rate (ORR)
Time Frame:4 years
Safety Issue:
Description:
Measure:Overall survival (OS)
Time Frame:4 years
Safety Issue:
Description:
Measure:Distant metastasis free survival (DMFS)
Time Frame:4 years
Safety Issue:
Description:
Measure:Number of drug related adverse events
Time Frame:4 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Trial Keywords

  • Neoadjuvant therapy
  • immunotherapy
  • Cytoxan
  • Cyclophosphamide
  • Pancreatic Vaccine
  • SBRT
  • GVAX
  • Nivolumab
  • borderline resectable
  • Radioimmunotherapy
  • Vaccine
  • Antibody
  • Anti-PD-1

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