Status:
COMPLETED
GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Bristol-Myers Squibb
Stand Up To Cancer
Conditions:
Previously Treated Metastatic Adenocarcinoma of the Pancreas
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 2 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2017
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT02243371
Start Date
January 2 2015
End Date
July 21 2017
Last Update
April 6 2021
Active Locations (5)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
Stanford University
Stanford, California, United States, 94305
3
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21205
4
Providence Portland Medical Center
Portland, Oregon, United States, 97213