GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab
Trial ID or NCT#
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).
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
- - 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.
- - 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
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