A Phase 2B, Randomized, Controlled, Multicenter, Open

A Phase 2B, Randomized, Controlled, Multicenter, Open-Label Study of the
Efficacy and Immune Response of GVAX Pancreas Vaccine (with
Cyclophosphamide) and CRS-207 Compared to Chemotherapy or to CRS-207
Alone in Adults with Previously-Treated Metastatic Pancreatic Adenocarcinoma
This is a randomized Phase 2B trial that will evaluate the safety, immune response and efficacy of the
combination immunotherapy of GVAX Pancreas (with low dose cyclophosphamide) and CRS-207
compared to chemotherapy or to CRS-207 alone in adults who have failed prior treatment for metastatic
pancreatic cancer. The GVAX family of vaccines, administered as six intradermal shots, is derived from
human cancer lines that are genetically modified to secrete GM-CSF, an immune-stimulatory cytokine.
CRS-207 is given as an infusion and is based on attenuated Listeria monocytogenes strains that have
been genetically modified to induce potent innate and T cell-mediated immunity. A previous Phase 2
study demonstrated that treatment with GVAX Pancreas and CRS-207 imporved overall survival and
doubled the 1-year survival probability for patients with previously treated, metastatic pancreatic
Site PI: Andrew Ko, MD
Contacts: McKinley Nickerson, [email protected], 415.514.6314
Inclusion Criteria:
-Have histologically-proven, malignant metastatic adenocarcinoma of the pancreas (measurable disease
is not required; mixed histology is not allowed)
-Have failed at least one prior chemotherapy regimen for metastatic pancreatic cancer; note the
• Failure on prior treatment regimens includes progression of disease or discontinuation due to
unacceptable toxicity
• Systemic chemotherapy regimens received as adjuvant therapy or for locally advanced disease
on which the subject develops metastatic disease will be considered treatment for metastatic disease;
radiosensitizing doses of chemotherapy are not considered systemic chemotherapy
• For the Primary Cohort, at least one of the prior treatment regimens must be a gemcitabinebased regimen (subjects in the 2nd-line Cohort are not required to have a prior gemcitabine-based
-Have adequate organ function, as defined by the laboratory values:
WBC ≥3,500/uL
Hemoglobin≥9 g/dL
Creatinine≤2.0x ULN
Albumin≥3.0 g/dL
Alkaline phosphatase ≤2.5 x ULN or <5.0 x ULN for patients with no liver metastases
Bilirubin ≤ULN or ≤3 x ULN if due to Gilbert’s disease
Exclusion Criteria:
-Have a known history or evidence of brain metastases
-Have a known allergy to both penicillin and sulfa
- Have any evidence of hepatic cirrhosis or clinical or radiographic ascites
- Have had a pulmonary embolism or venous thromboembolism within 2 months of study enrollment
-History of any autoimmune disease, including patients with a history of inflammatory bowel disease
(including ulcerative colitis and Crohn’s Disease), patients with a history of symptomatic disease (e.g.,
rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus,
autoimmune vasculitis [e.g., Wegener’s granulomatosis]); central nervous system or motor neuropathy
considered of autoimmune origin (e.g., Guillain-Barre Syndrome, Myasthenia gravis, multiple sclerosis);
patients with Graves’ or Hashimoto’s Disease will be allowed