Trial Search Results

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

This is randomized Phase 2 research 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. We hope to learn whether it is safe to give cyclophosphamide, GVAX pancreas vaccine, CRS-207 and nivolumab to treat people with advanced pancreatic cancer who have received one prior chemotherapy treatment for metastatic cancer (cancer that has spread beyond the pancreas).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborator: Lustgarten Foundation

Stanford Investigator(s):

Intervention(s):

  • Biological: CRS-207
  • Biological: CRS-207
  • Drug: nivolumab
  • Biological: GVAX
  • Drug: CY

Phase:

Phase 2

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