©2022 Stanford Medicine
GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab
Not Recruiting
Trial ID: NCT02243371
Purpose
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
Stanford Investigator(s)
George A. Fisher Jr.
Colleen Haas Chair in the School of Medicine
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
Intervention(s):
biological: CRS-207
biological: GVAX
drug: nivolumab
drug: CY
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061