RWF_J14113 ADU-CL-06

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

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).

Inclusion 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.

Exclusion Criteria:
• 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
Phase II
Todd Crocenzi, M.D.
Johns Hopkins University
Yue-Yun To
  • Oncology and Hematology Care Eastside