Education and Training

GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab

The primary objective of this study is to compare the overall survival (OS) of subjects with previously treated metastatic pancreatic cancer treated with cyclophosphamide (CY)/nivolumab/GVAX pancreas vaccine followed by nivolumab/CRS-207 (Arm A) to subjects treated with CY/GVAX pancreas vaccine followed by CRS-207 (Arm B).

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • biological: CRS-207
  • biological: GVAX
  • drug: nivolumab
  • drug: CY

Eligibility


Inclusion Criteria:

   - Age ≥18 years.

   - Have histologically- or cytologically-proven adenocarcinoma of the pancreas. Patients
   with mixed histology will be excluded.

   - Have metastatic disease.

   - Have failed only 1 prior chemotherapy regimen for metastatic pancreatic cancer.

   - Patients with the presence of at least one measurable lesion.

   - Patients acceptance to have a tumor biopsy of an accessible lesion at baseline and on
   treatment if the lesion can be biopsied with acceptable clinical risk (as judged by
   the investigator).

   - ECOG performance status 0 or 1.

   - Life expectancy of greater than 3 months.

   - Patients must have adequate organ and marrow function defined by study-specified
   laboratory tests.

   - Must use acceptable form of birth control while on study.

   - Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

   - known history or evidence of brain metastases.

   - Had surgery within the last 28 days

   - Have received any non-oncology vaccine therapy used for prevention of infectious
   diseases including seasonal vaccinations within 28 days of study treatment.

   - Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, GVAX or CRS-207

   - Systemic steroids within the last 14 days

   - Use more than 3 g/day of acetaminophen.

   - Patients on immunosuppressive agents.

   - Patients receiving growth factors within the last 14 days

   - Known allergy to both penicillin and sulfa.

   - Severe hypersensitivity reaction to any monoclonal antibody.

   - Have artificial joints or implants that cannot be easily removed

   - Have any evidence of hepatic cirrhosis or clinical or radiographic ascites.

   - Have significant and/or malignant pleural effusion

   - Infection with HIV or hepatitis B or C at screening

   - Significant heart disease

   - Conditions, including alcohol or drug dependence, intercurrent illness, or lack of
   sufficient peripheral venous access, that would affect the patient's ability to comply
   with study visits and procedures

   - Unable to avoid intimate contact with another individual known to be at high risk of
   listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the
   course of CRS-207 treatment until completion of antibiotic regimen.

   - Are pregnant or breastfeeding.

   - Have rapidly progressing disease

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting