GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab
Trial ID or NCT#
Status
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
Eligibility 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.
- * 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
Investigator(s)
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Contact
CCTO
650-498-7061
View on ClinicalTrials.gov