Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Aduro Biotech, Inc.
With
Johns Hopkins University
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Have histologically proven malignant adenocarcinoma of the pancreas; measurable disease is not required. (Subjects with mixed histology will be included if the predominant component is adenocarcinoma. Subjects must have metastatic disease.)
Have received or refused at least one chemotherapy regimen
At least 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Anticipated life expectancy of \>12 weeks
For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormone implants) must be used throughout the study period and for 28 days after their final vaccine administration. (A barrier method of contraception must be employed by all subjects \[male and female\], regardless of other methods.)
Be willing and able to give written informed consent, and be able to comply with all study procedures
Have adequate organ function as defined by specified laboratory values
You may not be if
Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
Known history or evidence of brain metastases
Have any evidence of hepatic cirrhosis or clinical or radiographic ascites
Have clinically significant and/or malignant pleural effusion
Known or suspected hypersensitivity to any component of GVAX Pancreas vaccine or CRS-207, or known allergy to both penicillin and sulfa
Received an investigational product within 28 days of study treatment or planned to receive within 28 days after vaccine administration
Used any systemic steroids within 28 days of study treatment
Use more than 3 g/d of acetaminophen
Prosthetic joint or other artificial implant or device that cannot be easily removed (there are some exceptions)
Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug, or planned surgery requiring general anesthesia
Infection with HIV or hepatitis B or C at screening
Any immunodeficiency disease or immunocompromised state or active autoimmune disease or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment
Be pregnant or breastfeeding
Unable to avoid close 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
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
