for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:



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).

Official Title

A Randomized Phase 2 Study of the Safety, Efficacy, and Immune Response of GVAX Pancreas Vaccine (With Cyclophosphamide) and CRS-207 With or Without Nivolumab in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma


Previously Treated Metastatic Adenocarcinoma of the Pancreas Adenocarcinoma Vaccines Cyclophosphamide Antibodies, Monoclonal Nivolumab Pancrelipase Pancreatin CRS-207 GVAX CY CY/ GVAX/ CRS-207/ nivolumab CY/ GVAX/ CRS-207


You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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


  • University of California, San Francisco
    San Francisco California 94143 United States
  • Stanford University
    Stanford California 94305 United States


in progress, not accepting new patients
Start Date
Completion Date
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase 2
Study Type
Last Updated